Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Manager, Clinical Manufacturing, Cell Therapy supports the clinical operations of the facility. The Manager will be responsible for the people manufacturing both clinical and commercial product with oversight of shifts that cover up to 24/7 cell therapy manufacturing unit operations such as media preparation, cell selection, cell processing, or product fill, all of which are executed in accordance with Current Good Manufacturing Practices (cGMP’s).  

Shifts Available:

TBD

Responsibilities:

• Supporting the development, implementation and compliance of manufacturing documentation, procedures and policies.
• Operating within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility.
• Maintaining operating and storage areas that are compliant, efficient, effective and safe.
• Identifying strategic and operational issues to prevent deviations and maintain a compliant environment. Leading and managing the development of corrective and preventative actions, deviation responses and investigations.
• Creating an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
• Efficiently coordinating, communicating, and providing Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines.
• Overseeing operators on daily basis as they:
• Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Maintain training assignments to ensure the necessary technical skills and knowledge.
• Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities.
• Be trained and proficient for floor operations.
• Hiring, mentoring and developing exceptional people
• Conducting performance reviews and identifying opportunities for career growth for manufacturing associates.

Knowledge, Skills, Abilities:

• Experience in cell therapy manufacturing techniques, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment is highly preferred.
• Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is highly preferred.

Minimum Requirements:

• 5+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelors in relevant science or engineering discipline, or equivalent in work experience.

Working Conditions:

• This position will require shift work, including holidays and weekends.
• This position will require you to work in a clean room environment, with exposure to human blood components and in close proximity to strong magnets.

BMSCART

#LI-ONSITE

GPS_2025

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Medical Director RPI has responsibility for the development of RayzeBio’s diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio’s diagnostic imaging portfolio. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates

• Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents.

• Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents

• Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators

• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets

• Translate findings from research and nonclinical studies into diagnostic imaging development opportunities

• Oversee Data Review and Independent Data Monitoring Committees as applicable

• Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines

• Establish and maintain positive relationships with clinical trial investigators and thought leaders

• Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.

• Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging.

• Willing to travel approximately 30% of the time. Evening and weekend work will be involved.

Education and Experience

• MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years’ experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process.

Skills and Qualifications

• Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics

• Motivated to work in a fast-paced, high accountability, and small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.

• Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail.

• Demonstrated ability to collaborate successfully with multiple functions in a team environment.

• Intellectually curious with courage to challenge and seek new ways to improve work.

• Strong written and oral communication skills, including presentation skills.

• Ability to analyze and interpret data and develop written reports and presentations of those data.

• Strong critical, strategic, and analytical thinking skills.

• Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting.

• Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials.

• Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval.

• Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).

• Solid understanding of GCP and ICH guidelines.

Physical demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

The noise level in the work environment is usually moderate.

#RayzeBio

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

Cell Therapy Network Lead investigator will support the commercial and late stage clinical cell therapy network for complex trend investigations stemming from deviations and SAEs.  The lead investigator will assemble and lead cross functional matrix teams necessary to close complex trend investigations. He/she will participate in strategic discussions, anticipate bottlenecks, technical risks, and address issues proactively, while fostering an environment of teamwork.  The person will collaborate with SMEs, user groups, quality groups, and other stakeholders to complete complex trend deviations and CAPAs

Key Responsibilities

• Serve as lead investigator for global trend investigations and global SAE events. 
• Support site based investigators for complex trend investigations
• Manage complex cross-functional projects/programs using project management techniques and tools that is appropriate for the given project

Qualifications & Experience

• Bachelor’s degree or equivalent in relevant discipline with a minimum of 5 years of relevant experience. Masters preferred (but not required).  Time spent in advanced degree programs may be considered as equivalent relevant experience
• Green Belt or Black belt is preferred but not required
• Expert understanding of cGMP regulations and/or business and documentation processes.
• Expert in root cause analysis, CAPA and risk mitigation
• Proficient in project and portfolio management skills

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

We are seeking a highly motivated professional to join the Cell Therapy Analytical Development team, specializing in cell line engineering and potency method development for viral vector applications. The ideal candidate will contribute to the optimization and qualification of cell-based viral vector transduction assays measured by flow cytometry and luminescent reporter genes. This position demands a strong foundation in cell culture, keen attention to detail, and enthusiasm for solving scientific challenges in a fast-paced, collaborative environment.

Successful candidates will demonstrate competency in these areas and contribute to breakthrough developments in cell therapy.

Key Responsibilities

• Generate monoclonal cell lines and establish cell banks by transducing cells with viral vectors, expanding the cultures, isolating monoclonal populations through cell sorting, banking the validated cell lines, and performing functional qualification using lot-release potency and flow cytometry assays. Design and execute laboratory experiments to optimize DNA/RNA transfection, viral transduction, flow cytometry and plate based potency reporter gene assay parameters and procedures to meet the pre-defined analytical target profile.
• Contribute to method qualification and transfer activities based on ICH/USP guidelines.
• Analyze complex data sets, perform data trending and visualization, and maintain detailed experimental records in ELN for reproducibility and quality assurance.
• Document cell line generation processes and experimental findings, contributing to SOPs, technical reports, and regulatory filings to ensure compliance and support innovation.
• Cultivate and maintain cell lines and primary cells essential for innovative assay development.
• Manage lab operations by overseeing inventories, scheduling equipment maintenance, and implementing process improvements for efficiency and productivity.

Qualifications & Experience

• Ph.D. in Immunology, Cell Biology, Bioengineering, or a related field with 0–3 years of industry experience; or an MS/BS with 5+ years of relevant laboratory experience.

• Proficiency in cell culture, viral vector transduction, cell line engineering, flow cytometry, and relevant analytical assays (e.g., ELISA).
• Experience with JMP and SoftmaxPro softwares is preferred. 
• Experience with vector construct design is highly desirable.
• Background in DNA/RNA transfection, viral vector transduction, and potency release method development is preferred.
• Strong organizational, documentation, and communication skills.
• Ability to thrive in a collaborative, fast-paced, and dynamic environment.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Senior Corporate Counsel, Disclosure & Securities Law will provide legal counsel on securities and disclosure matters for a public company, managing the voluntary and required public disclosures initiated by Corporate Affairs and Investor Relations, among others, managing appropriate knowledge groups for highly sensitive and material information and implementing trading holds as appropriate. This role supports key governance functions and SEC-related activities, ensuring compliance and advising senior leadership.

Key Responsibilities

• Provide legal guidance on appropriate method and timing of public disclosures, ensuring legal review and compliance with all statements made, including securities and regulatory law compliance for a public company.

• Establish and enforce unblinding lists and processes for all highly sensitive and material information within the company; implement securities trading holds as appropriate.

• Support SEC filings, including Forms 10-K, 10-Q, 8-K, Schedule 13D/G, Forms 3 and 4, and investor disclosures.

• Support corporate finance transactions, including securities offerings, debt/equity repurchases, and credit agreements.

• Collaborate with senior leadership, finance, and legal teams to align governance strategy with regulatory obligations.

Qualifications & Experience

• 10-12 years of experience at a law firm and/or a public company, preferably pharmaceutical experience.

• J.D. from an accredited U.S. law school and license to practice law in the U.S.

• Strong organizational acumen and maturity within a highly complex matrixed organization.

• Expertise in U.S. Securities and Exchange Commission (SEC) reporting requirements and governance principles.

• Strong judgment, execution, communication, and cross-functional collaboration skills.

• Experience supporting senior leadership and corporate transactions.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

HCP Strategy Lead is a core member of the brand team, responsible for scientific, non-promotional and educational interactions with healthcare practitioners and supporting tactic execution to achieve brand objectives.

HCP Strategy Lead owns the end-to-end HCP customer journey and strategy that ladders into overarching brand strategy. This individual maintains a deep understanding of HCP customer needs and leverages insights and analytics to build strategic initiative for the development of the Disease Strategy. HCP Strategy Lead collaborates closely with cross-functional leaders (Medical, Commercial, Access, WCE) to ensure strong strategic planning and execution.

Key Responsibilities

Strategy Development

• Builds and delivers the TA strategy and plan that drives success

• Owns the end-to-end HCP customer journey and it’s a key partner for the Brand Lead in defining educational needs and driving scientific initiatives to secure proper understanding of the disease and treatment options.

• Interacts with HCP for defined activities in alignment to strategic needs.

• Fosters collaborative working relationships with the Brand Lead and cross-functional brand team members to ensure creation of a unified brand strategy

• Integrates insights from advanced analytics models and market research to develop HCP customer journey, customer segments and create tailored omnichannel strategies, optimizing channel selection, actively working with Brand Lead, Omnichannel strategist and all team stakeholders

• Leverages omnichannel capabilities and rapid, personalized content creation processes to enhance customer experience and engagement

• Utilizes engagement and performance feedback to improve customer engagement strategies and campaigns

• Defines KPIs of success for the HCP customer segment​ activities and for the Omnichannel interactions.

Execution Excellence

• Secure reporting of focused and On label HCP interactions in line with Brand Lead

• Collaborates with Access, Commercial and Medical teams to translate insights into compliant Brand strategic imperatives and strategic initiatives

• ​Plans and delivers content across personal and non-personal channels in alignment with brand goals,

• Works with analytics and market research teams to define and implement performance metrics

• Setting up strategies and execute key projects in the TA to secure Scientific Leadership

• Champions modular content production and omnichannel deployment in collaboration with Omnichannel COE, BI&A, and agencies, focusing on nonpromotional initiatives

Required Qualifications & Experience

• Strong scientific experience with a track record of leading and executing HCP-focused strategies

• Experience in Cardiovascular preferred

• Ability to work in Matrix and have managed one or more direct reports

• Knowledge of HCP customer journeys, preferences, and needs​ within Cardiovascular

• Fluency in interpreting analytical models and ability to translate analytics from BI&A teams into actionable strategies​

• Familiarity with omnichannel strategy and modular content production

• Ability to navigate and build relationships across teams and functions (e.g., Medical, Commercial, Access, Sales)​

• Ability to collaborate with new capability centers (e.g., Omnichannel COE) and adapt new processes (e.g., iterative MLR process)   

• Demonstrated leadership experience and ability to lead teams​

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Responsibilities:

• Tracks, collects, and reviews all components for submission to Health Authorities.

• Perform submission publishing activities

• Interacts with responsible parties for quality submission documents for submissions.

• Facilitate submission team meetings with team support.

• May participate in focused projects related to their scope of work.

• Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission).

• Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines.

• Coordinate Initial IND Kick off meeting submission.

• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.

• Develop/Update job aid documents for departmental process.

• Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist).

• Coordinate non-eCTD submissions with International Regulatory Team lead.

Requirements :

•  2-4 years relevant experience in regulatory submissions.

•  Foundational knowledge of global regulatory practices, submission guidelines and requirements.

• Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint).

• Hands-on experience in submission publishing activities using DocuBridge, Lorenz and other relevant software (e.g., Veeva)

•  Assists in the implementation of short- and long-term goals within own work group within RISM.

• Come prepared with a solution to questions and issues as they arise.

• Engages relevant stakeholders to help address the problem.

• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.

• Demonstrates basic presentation skills needed to deliver content to a variety of audiences.

• Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.

• Communicates project status and updates, as appropriate, to relevant stakeholders.

• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.

• Proposes alternative solutions for submission-related and/or project situations.

• Seeks to understand stakeholder needs, priorities, working processes, and activities.

• Understands and embraces the use of specific regulatory systems and associated tools based on area of expertise or job function.

• Has intermediate-level working knowledge of common desktop software (eg, Microsoft Office Suite, Adobe Acrobat, and SharePoint).

Educational Qualifications:

• BA/BS degree, science / technology field preferred.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

概要 (High-level Description; including manage team/individuals or not)

シニアスペシャリストの役割は、個々の役割に応じて、中間製品及び原材料の試験を実行する責任がある。また、必要に応じて、ハウスキーピング、プロジェクトなどの試験室運用活動もサポートする。下位職位者のメンターとトレーニングを支援し、スケジューリングと計画にインプットし、必要に応じて試験室管理の代理人として機能する。

役割と責任範囲 (Roles & responsibilities)

その業務に従事する場合にカバーする全範囲、責任が及ぶ範囲、成/否時のビジネスインパクト、グローバルチームとの関わり度合い、対応するステークホルダーの種類と範囲、どの程度上位者のサポートを受けないと期待値を満たさないか、チーム/部の構成員に対するパフォーマンスの極大化（評価/育成/モチベーション/職場環境の適正化）を図る場合に必要な要素、レポート関係に無いチームの取りまとめがある場合はその旨記載し必要な要素を含める。

・SMEとして下記の役割を上位者のアドバイスを得ながらも、自らの判断に基づいて独立して実行できる。

• 中間製品及び原材料の複雑及び非複雑な方法の試験（ルーチンテスト、環境モニタリング、安定性試験等）を個々の役割に応じて実施する。
• 試験法、SOP等の技術文書を必要に応じて作成し、レビュー及び改訂を行う。
• 以下の1～7の業務を行い、試験機器の導入から廃棄までのライフサイクルマネジメントを主導する。
• 1 試験機器の導入計画を主導し、要求仕様を作成する。
• 2 試験機器の導入・変更・廃止に伴う変更管理を作成し、プロジェクトを主導する。
• 3 試験機器導入に関するバリデーション計画書及び報告書の作成及びバリデーションの実施を主導する。
• 4 試験機器/操作の原理を十分に理解し、機器操作手順書の作成を主導する。
• 5 試験機器の定期的な校正/保守点検のシステムを確立する。また、定期校正/保守点検のスケジュール管理を行い、点検報告書を作成する。
• 6 試験機器に関するユーザー管理及びデータ管理を主導する。
• 7 試験機器の故障時の場合は適切な対応をとる。
• 外部業者に委託する試験機器の校正/保守点検業務に関して、日本のGMP要求事項及びBMS要求事項に適合させる。
• 試験機器の校正/保守点検のためのMaximo等のITシステムの活用を主導し、システムデータ等の維持管理を行う。
• 必要な場合は、BMS他サイトとのコミュニケーションをほぼ独立して行う。
• 上記以外の割り当てられたタスクを実行する。

・チーム内のプロジェクトを主導する。必要な場合は、複雑なプロジェクトに貢献する、または主導する。

・チーム内外のオペレーショナルエクセレンス(OpEx)および継続的改善(CI)活動に積極的に参加する。

・チーム外のクロスファンクショナルな活動に積極的に参加する。

・BMSバリューを一貫して意図的に体現し、必要な全てのタスクをコンプライアンス及び安全に準拠し、完了する。

必要な知識/スキル (Required knowledge/skills)

その業務に従事する場合に必要な知識、スキル、経験、コミュニケーション（言語力含む）/協力のレベル、深さ、範囲と言った要素を含む。

(Range of knowledge/skills/experience required and degree/depth/scope of communication (Inc. language skill)/corroboration.)

• 国内外のGMP要求事項及びBMS社内GMP要求事項を理解し、適用できるスキル
• 日本薬局方を理解し、適用できるスキル
• 業界のベストプラクティスを情報収集し、適用できるスキル
• 技術文書（バリデーション文書、操作手順書等）を作成できるスキル
• 問題解決能力・メンタリティを持ち、技術的に精通し、論理的思考を持つ
• タスクの完了、ニーズに関して、同僚またはステークホルダーと効果的にコミュニケーションをとるスキル
• ペースの速いチーム環境で業務を遂行し、複数のタスクの期限を管理し、優先順位を付けできるスキル
• 英語で読み書き、会話ができるスキル
• 関連分野で5年以上の経験を持つ学士号、または3年以上の経験を持つ修士号、または1年以上の経験を持つ博士号、または 非関連分野で9年以上の経験を持つ学士号、または同等の教育と経験の組み合わせの知識

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Responsibilities:

• Tracks, collects, and reviews all components for submission to Health Authorities.

• Perform submission publishing activities

• Interacts with responsible parties for quality submission documents for submissions.

• Facilitate submission team meetings with team support.

• May participate in focused projects related to their scope of work.

• Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission).

• Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines.

• Coordinate Initial IND Kick off meeting submission.

• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.

• Develop/Update job aid documents for departmental process.

• Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist).

• Coordinate non-eCTD submissions with International Regulatory Team lead.

Requirements :

•  5+ years relevant experience in regulatory submissions.

•  Foundational knowledge of global regulatory practices, submission guidelines and requirements.

• Proficient working knowledge of common desktop applications (e.g., Microsoft Office Suite, Adobe Acrobat, SharePoint).

• Hands-on experience in submission publishing activities using DocuBridge, Lorenz and other relevant software (e.g., Veeva)

•  Assists in the implementation of short- and long-term goals within own work group within RISM.

• Come prepared with a solution to questions and issues as they arise.

• Engages relevant stakeholders to help address the problem.

• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.

• Demonstrates basic presentation skills needed to deliver content to a variety of audiences.

• Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.

• Communicates project status and updates, as appropriate, to relevant stakeholders.

• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.

• Proposes alternative solutions for submission-related and/or project situations.

• Seeks to understand stakeholder needs, priorities, working processes, and activities.

• Understands and embraces the use of specific regulatory systems and associated tools based on area of expertise or job function.

• Has intermediate-level working knowledge of common desktop software (eg, Microsoft Office Suite, Adobe Acrobat, and SharePoint).

Educational Qualifications:

• BA/BS degree, science / technology field preferred.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Senior Scientist will serve as the designated point of contact for Aichi and the analytical network, frequently interaction with global analytical science and product development teams. The incumbent will be subject matter expert for the analytical portion of new product introduction and for a number of test methods/processes across multiple products, anticipate and perform complex troubleshooting and problem-solving independently.

The incumbent will manage and deploy, in collaboration with other QC members, continuous improvement and simplification initiatives. 

This role will own generation of protocols and reports, and other documents aligned with regulatory and corporate guidelines. The Senior Scientist will also represent the department in product review boards and regulatory inspections, both internal and external, and may author responses to regulatory requests.

They will lead transfers, validations, projects, CAPAs, and deviations/investigations, and continuous improvement efforts.Furthermore, the Senior Scientist will train and mentor others on multiple QC test methods, processes, and procedures and perform other tasks as assigned.

Duties/Responsibilities
 

General Level Responsibilities

• Designated Subject matter expert for a number of test methods/processes across multiple products
• Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
• May own scheduling of assignments in consultation with manager.
• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
• Represent the department in product review boards and regulatory inspections (internal and external audits).
• May author responses to regulatory requests.
• Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts.
• Anticipate and perform complex troubleshooting and problem solving independently.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes and procedures.
• Perform other tasks as assigned.
• Owns and contributes to change controls.
• May act as delegate for laboratory management, as required. 
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
• Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation.
• Champion and foster a positive, supportive, and collaborative quality culture.
• Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion).

Key Job Competencies

• Advanced ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements accurately and completely.
• Demonstrated advanced technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Excellent attention to detail and demonstrated organizational skills.
• Ability to communicate effectively with peers, senior leaders and stakeholders across multiple departments and sites also in English
• Demonstrated strategic & enterprise thinking
• Advanced ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced use and knowledge of LIMS, ELN and laboratory data analysis.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

Role Specific Assignments:

• Lead analytical test method transfer for new product launch
• Lead alignment of CoA and test method of DP site with External Manufacturing or BMS sites for MRA application
• Lead introduction of analytical instruments
• Lead Continuous Improvement Initiatives and enhancement of GMP compliance in QC lab

Qualifications

• Bachelors Degree in a non-technical discipline with ≥13 years experience, or
• Bachelors Degree in a Scientific or relevant Technical area  with ≥9 years experience, or
• Masters Degree in a Scientific or relevant Technical area with ≥7 years relevant experience, or
• PhD in a Scientific or relevant Technical area with ≥5 years relevant experience.
• Able to write, read, and speak English fluently
• An equivalent combination of education and experience, preferably in a regulated environment will be considered.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.