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At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities:

Working with the Group Director, Medical Education you will be expected to manage and implement a digital collaboration capability and lead communications to the broader organization that highlight the value of Medical Education.  Additionally you will be responsible for evaluating opportunities for department innovation, continuous improvement, and process enhancements.  As the Technology champion for the team you will be responsible for learning about the new technology rollouts and implementing to team, as appropriate.

Programs and tools may include but are not limited to: 

• Managing SharePoint sites

• Building/Maintaining Sub sites 

• Configuring Sites (included enhanced site setups)  

• Creating/Maintaining Security Model 

• Creating/Maintaining Documentation  

• Site Health Checks 

• Metrics 

• Working with the TA IME Managers, Maintain calendar of live IME events

• Overhaul and maintain the IME Program Evaluation, enhancing usability and increasing participation from matrix partners

• Build and maintain IME presence on Yammer

• Plan annual poster gallery day, managing timelines and tasks, keeping the team on schedule and identifying any issues

In delivering this work, you will be expected to: 

• Manage multiple projects simultaneously 

• Create tactical project timelines 

• Provide recommendations that support the overall strategy 

• Maintain partnerships with clients 

• Troubleshoot user challenges with SharePoint Sites and other tools/resources

• Share best practices that apply across TAs  

• Communicate clearly, apply strong writing and presentation skills  

• Balance working independently and working within the team structure  

• Understand and support SharePoint services model 

• Understand (at a high level) the Medical Education Grant Process and Outcomes dissemination

In addition to the above job responsibilities, the position will be required to provide administrative support to the team, including calendar management and cross coverage for the broader portfolio strategy team when need to cover administrative vacation/absence.

Experiences Desired:

• Bachelor's Degree

• Minimum 2-3 years of medical and/or industry experience preferred. Medical Education experience a plus.

• Proficient in building and Maintaining SharePoint Online Collaboration Sites.    

• Excellent project management, customer service, and organization skills with the ability to manage multiple activities simultaneously.    

• Familiarity with social media platforms and practices. 

• Strong computer skills including MS Office 365 and especially a demonstrated mastery of SharePoint Online.  Knowledge of HTML, JavaScript and other scripting languages a plus.

• Possess strong verbal and written communication skills; strong attention to detail

• Possess strong collaboration skills within a matrix environment

• Strong analytical and problem solving abilities

• Experience partnering with vendors

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Title:

Manufacturing Associate, CAR T Media and Solution Preparation, Manufacturing Operations Quad 1, 2, 3 or 4

Direct Manager:

Manager, CAR T Media and Buffer Preparation

Division:

CTDO Manufacturing Services

Grade:

B22

Direct Reports:

N/A

Location:

Summit West, S12

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

Formulation of cell culture media and solutions in support of S12 CAR T manufacturing per Standard Operating Procedures (SOPs) in a controlled, cleanroom environment. This position is for the This position is for one of the following shifts, Quad 1 (Sunday – Every other Wednesday 5:00 am - 5:30 pm), Quad 2 (Sunday – Every other Wednesday 5:00 pm - 5:30 am), Quad 3 (Every other Wednesday - Saturday 5:00 am - 5:30 pm) or Quad 4 (Every other Wednesday - Saturday 5:00 pm - 5:30 am). Start and end times are subject to change based on business demands.

This position is for the Manufacturing Organization.

This position requires Manufacturing Associate or equivalent experience.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

- Understanding of media and solution preparation requirements for cell culture.

- Aseptic processing and lab techniques.

- Advanced proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.

- Familiarity with cGMP/FDA regulated industry.

- Basic mathematical skills.

- Ability to read, execute and document steps in a GMP batch record.

- Proficient in MS Office applications.

- Background to include a basic understanding of biology, chemistry, or pharmaceutical processing

Education and Experience:

Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience

OR

High School diploma/GED and 3 years of Manufacturing or Operations experience.

DUTIES AND RESPONSIBILITIES:

- Maintain up to date records for training on controlled, approved GMP procedures for Media and Solution preparation to support CAR T manufacturing.

 - Assist with Lab Support activities: Coordinate with Warehouse Operations to move materials into the process suites and serve as a runner when needed.

 - Participate in shift exchanges of information to ensure seamless operations.

 - Other duties may be assigned, as necessary.

WORKING CONDITIONS (US Only):

- Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.  

- Physical dexterity sufficient to use computers and documentation.

- Sufficient vision and hearing capability to work in job environment. 

- Ability to lift up to 25 pounds. 

- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.

- Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.

- Flexibility to don clean room garments and personal protective equipment (PPE).

- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.

- Use of reagents, chemicals, and exposure to sanitization agents are expected. 

 - Ability to work in the vicinity of strong magnets.

- Potential routine exposure to human blood components is possible.

- Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum. 

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Bristol Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Profile Description:

The Senior Manager, Clinical Trial Business Delivery will be supporting the Global Development Organization (GDO) in delivering BMS’ clinical development portfolio. This role will be working both within the GDO team as well as other functions across the broader R&D organization.

This role will drive activities in two key areas: governance and metrics/KPIs. From a governance perspective, this position will enable the tools, processes, and framework that empower the business leaders to effectively manage their responsibilities as it relates to the achievement of business deliverables. In regard to metrics and KPIs, the incumbent will work with internal stakeholders to understand and develop requirements for the data required to effectively oversee and proactively manage the book of work.

Additionally, the Senior Manager, Clinical Trial Business Delivery will be interfacing with other functions across R&D to support any governance processes and metric/KPI needs as they arise.

Key Responsibilities and Major Duties

GDO governance oversight and execution:

• Support stakeholders to develop materials in support of governance reviews (e.g. study dashboards, reports)
• Support the creation and assessment of portfolio-level information for senior management to review for strategic and tactical decision-making
• Support the assessment of operational data across different parameters (e.g. therapeutic areas, geographies)
• Meeting management & support. This includes the management of the following key items: SharePoint, Calendar, Agenda creation and finalization, Material collection
• Track and manage governance actions to ensure follow through to completion

Metrics and KPIs

• Support GDO business stakeholders to identify metrics and KPIs that enable proactive management and execution of the book of work
• Maintain the metrics and KPIs related to operational performance of the GDO organization to senior management teams
• Support the assessment of trends to develop recommendations for continuous improvement
• Partner with the Business Information and Analytics (BI&A) organization to implement metrics and dashboards

Requirements

• Bachelor’s degree required with an advanced (Masters) degree preferred.
• Minimum of 8 years of experience within a clinical development organization
• Experience working with operational clinical trial data
• Robust understanding of biopharmaceutical industry, clinical trial conduct, regulatory and safety processes, and the external and internal Business Environment
• Knowledge of GCP/ICH guidelines and regulations
• Proven ability to build strong relationships with external stakeholders and partners
• Experienced in preparing content for and interacting with Senior Executive stakeholders
• Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
• Experience working and influencing in a matrix environment
• Strong project management and planning skills
• Effective oral and written communication skills to influence, inform, or guide
• Ability to travel as required.

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 the resources to pursue their goals, both at work and in their personal lives.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Associate Director, Regional Marketing -  Zeposia UC

Department – US Marketing

Direct Manager- Senior Director, Field Marketing, Zeposia

Location- Field covering KY, OH, WV, and Western PA

Direct Reports- N/A

Summary

The Associate Director, Regional Marketing -  Zeposia UC role is a senior in-market position within the US commercial organization that will focus on commercial KOL engagement to gain insights into regional opportunities and provide a bridge between regional markets and headquarters, speaker development and refresher training for disease state (and product, when appropriate), and will support the execution of approved patient programs. Regional Marketing will liaise with other field-based professionals, within approved SOPs, including but not limited to RSDs, DMs, Market Access Account Executives and RMLs, as appropriate, in addition to home office-based colleagues in Marketing, Sales, Market Access and Medical Affairs, as appropriate.  The position will report to the Director, Regional Marketing and be part of the US GI Marketing team. 

Responsibilities- include but are not limited to the following;

• Establish BMS as a credible and trusted partner amongst the thought leaders in GI
  • Engage with assigned KOLs and solicit feedback, as necessary
  • Supports disease state or product, when appropriate conversations focused on key topics
  • Executes physician engagement activities in the field and at key congresses
• Advance Organizational Capabilities and Effectiveness by embedding the Regional Marketing function
  • Works with cross-functional teams to provide key customer insights and input on strategy, tactics, and messaging, and program execution
  • Provides input and support in developing account plans for Sales
  • Provides field-based training for Sales when needed
• Achieve Day 1 Launch Readiness in GI
• Speaker Program Management & Engagement
  • Provides field-based training to speakers on speaker programs when needed
  • Monitors speaker performance at live programs
  • Ensures appropriate and compliant execution of speaker programs
  • Provides refresher and follow up training to speakers on PACT-approved speaker materials
  • Develops physician speakers to provide high-quality speaker programs on disease state and product, when appropriate
• Conduct all aspects of business in compliance with BMS’s values, policies, SOPs, and the laws, regulations and codes that apply to our business.

Skills/Knowledge Required:

• Minimum 5 years of experience in one of the following: product marketing, field sales or medical affairs
• Minimum 5 years specialty experience. UC or Gastroenterology strongly preferred
• Marketing, Sales Management, and / or launch experience strongly preferred
• Experience with thought leader engagement, ad boards and speaker’s bureau strongly preferred
• Proven ability to manage large geographical territory
• Demonstrated ability to build productive stakeholder relationships and effectively meet their needs
• Ability to inform strategies, develop tactics and execute against strategic plans under short timelines that will help to achieve the desired goals
• Strong business acumen. Understands market dynamics, business drivers, corporate goals and impact on strategy
• Clinical knowledge and aptitude in complex disease states. Desire to continuously learn and improve by applying new knowledge and skills on the job
• Effective verbal and written communication skills and organizational abilities
• Self-driven with strong organizing and planning skills. Able to determine effective approaches and take the appropriate action based on the available information and consistent with the over-arching strategy
• Ability to leverage appropriate interpersonal styles and techniques to gain acceptance of ideas or plans
• Highly collaborative with the ability to manage multiple projects simultaneously
• Willingness to try different and novel ways to deal with work problems and opportunities.
• Business travel, by air or car, is regularly required
• Willingness to work evenings and select weekends is required
• Must live in territory: KY, OH, WV, and Western PA (Pittsburgh, Cleveland, Cincinnati preferred)
• Relocation not available
• As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and 3) a driving risk level deemed acceptable by the Company.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Associate Director, Regional Marketing -  Zeposia UC

Department – US Marketing

Direct Manager- Senior Director, Field Marketing, Ozanimod

Location- Field covering VA, NC, SC, and eastern TN

Direct Reports- N/A

Summary

The Associate Director, Regional Marketing -  Zeposia UC role is a senior in-market position within the US commercial organization that will focus on commercial KOL engagement to gain insights into regional opportunities and provide a bridge between regional markets and headquarters, speaker development and refresher training for disease state (and product, when appropriate), and will support the execution of approved patient programs. Regional Marketing will liaise with other field-based professionals, within approved SOPs, including but not limited to RSDs, DMs, Market Access Account Executives and RMLs, as appropriate, in addition to home office-based colleagues in Marketing, Sales, Market Access and Medical Affairs, as appropriate.  The position will report to the Director, Regional Marketing and be part of the US GI Marketing team. 

Responsibilities- include but are not limited to the following;

• Establish BMS as a credible and trusted partner amongst the thought leaders in GI
  • Engage with assigned KOLs and solicit feedback, as necessary
  • Supports disease state or product, when appropriate conversations focused on key topics
  • Executes physician engagement activities in the field and at key congresses
• Advance Organizational Capabilities and Effectiveness by embedding the Regional Marketing function
  • Works with cross-functional teams to provide key customer insights and input on strategy, tactics, and messaging, and program execution
  • Provides input and support in developing account plans for Sales
  • Provides field-based training for Sales when needed
• Achieve Day 1 Launch Readiness in GI
• Speaker Program Management & Engagement
  • Provides field-based training to speakers on speaker programs when needed
  • Monitors speaker performance at live programs
  • Ensures appropriate and compliant execution of speaker programs
  • Provides refresher and follow up training to speakers on PACT-approved speaker materials
  • Develops physician speakers to provide high-quality speaker programs on disease state and product, when appropriate
• Conduct all aspects of business in compliance with BMS’s values, policies, SOPs, and the laws, regulations and codes that apply to our business.

Skills/Knowledge Required:

• Minimum 5 years of experience in one of the following: product marketing, field sales or medical affairs
• Minimum 5 years specialty experience. UC or Gastroenterology strongly preferred
• Marketing, Sales Management, and / or launch experience strongly preferred
• Experience with thought leader engagement, ad boards and speaker’s bureau strongly preferred
• Proven ability to manage large geographical territory
• Demonstrated ability to build productive stakeholder relationships and effectively meet their needs
• Ability to inform strategies, develop tactics and execute against strategic plans under short timelines that will help to achieve the desired goals
• Strong business acumen. Understands market dynamics, business drivers, corporate goals and impact on strategy
• Clinical knowledge and aptitude in complex disease states. Desire to continuously learn and improve by applying new knowledge and skills on the job
• Effective verbal and written communication skills and organizational abilities
• Self-driven with strong organizing and planning skills. Able to determine effective approaches and take the appropriate action based on the available information and consistent with the over-arching strategy
• Ability to leverage appropriate interpersonal styles and techniques to gain acceptance of ideas or plans
• Highly collaborative with the ability to manage multiple projects simultaneously
• Willingness to try different and novel ways to deal with work problems and opportunities.
• Business travel, by air or car, is regularly required
• Willingness to work evenings and select weekends is required
• Must live in territory:  VA, NC, SC, or Eastern TN (Virginia Beach, Raleigh, or Charlotte preferred)
• Relocation not available
• As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and 3) a driving risk level deemed acceptable by the Company.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities for this position include, but are not limited to, the following:

• Translational Development Functions: · Part of the TD Leadership team responsible for defining and positioning the early oncology portfolio in collaboration with VP, Translational Development and colleagues in research, clinical development, and marketing
• Medical lead for clinical trials in hematology and oncology from Candidate Nomination (pre-IND) through Proof-of-Concept including: · Articulating the clinical development strategy · Design, implementation and analysis of early stage clinical trials · Clinical leadership on cross-functional Early Development project teams
• Close liaison with Translational Development Scientists, Discovery and Development Teams for defining Clinical PD or Biomarker assays.
• Responsible for clinical drug safety monitoring and management, in conjunction with the drug safety physician.
• Ad Hoc member of the Candidate Development Committee, that evaluates all IND candidates and Early Development programs.
• Key resource for disease area expertise for the TD team.
• Liaise with clinical and laboratory-based academic investigators in Early Oncology and be a focal point for defining and establishing relationships with key Global Phase 1 Centers.
• Part of the team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies for cost effective implementation of Celgene’s R&D and early development strategy.
• Participate in formulating disease area strategy for target selection and validation.
• Provide support to Business Development and the established teams, for potential in-licensing opportunities that may include potential therapeutics, emerging technologies, processes or capabilities that will enhance our Drug Discovery and Early Development efforts.

  
Skills/Knowledge Required:

• MD or M.D./PhD,
• MD is required.
• 3 years relevant experience in translational research/Phase 1 clinical trials  (e.g., IND submittals, Proof-of-Concept studies, first-in-patient studies, adaptive design studies, biomarker development, companion diagnostics, mechanism of action studies). Industry experience preferred but not required. Subspecialty board certification in hematology/oncology preferred.
• Experience in leading innovative efforts to deploy technologies and assays for enhanced translational capabilities.
• Superior leadership, management and organizational skills, and a reputation as an open, available and transparent communicator.
• Science and patient driven.
• Ability to interact effectively across boundaries using influencing and relationship building skills.
• Ability to function at the interface of both the Discovery and Development teams, with the aim of providing the successful implementation of stratification strategies, clinical biomarker and pharmacodynamic assays in the early clinical studies.
• Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals.
• Domestic and international travel is expected as required.

Prerequisites:

• Advanced degree(s) in relevant field (Hematology, Oncology): MD or MD/PhD. .
• 3 years relevant experience in translational research/Phase 1 clinical trials  (e.g., IND submittals, Proof-of-Concept studies, first-in-patient studies, adaptive design studies, biomarker development, companion diagnostics, mechanism of action studies). Industry experience preferred but not required. Subspecialty board certification in hematology/oncology preferred. MD is required.
• MD required.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible

Purpose of the Position:

The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, and small-scale projects in order to complete departmental objectives.

Essential Functions:

Historical Performance Review:

• Execute the historical performance review (HPR), a periodic review of equipment performance and use.
• Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
• Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
• Identify and recommend actions to take as a result of the completed HPR.
• Write deviation and perform investigation per internal procedure.
• Track HPR recommendations and remediation actions.

Ensure ECQ Departmental Compliance:

• Participate in revisions to departmental procedures to ensure compliance.
• Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines.

Compliance Projects:

• Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
• Lead projects both small and large in scope required to keep equipment or the department in compliance.

Ensure Equipment Compliance:

• Receive and review revisions to USP, EP, JP, FDA regulatory guidelines. Provide guidance to the team if changes are required.
• Perform gap analysis on existing equipment and technologies to ensure compliance.
• Review new equipment and technologies as it comes to site to ensure compliance.

Regulatory Responsibilities:

• Assist in the preparation for both internal and external audits.

Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:

• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Strong attention to detail.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Strong presentation development and delivery skills.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Ability to organize and present data and findings clearly.

Competencies:

• Professional Knowledge
• Action and detail oriented
• Team Player / Building Relationships
• Multi‐tasking
• Customer Focus
• Problem Solving
• Active Listening

Education & Experience:

• BS degree or equivalent experience
• Minimum 5 years of experience in FDA-regulated industry

Working Conditions:

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.

Environmental Conditions:

• Primarily an office environment.  Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

POSITION SUMMARY: 

The primary role of the Bioprocess Associate II is following detailed procedures and batch records ensuring compliance with

cGMP and safety requirements.  The Bioprocess Associate works on assignments that are moderately complex in nature, where

judgment is required in resolving problems and making routine recommendations.  Work is performed in a team environment

within a medium-scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). 

Additional gowning through the processing areas and maintaining clean hygiene is a requirement to control established

environmental specifications.

Duties/Responsibilities: 

· Operates control systems and processes supporting biologics process manufacturing.

· Operates primary production equipment and completes process operations within the assigned functional area (i.e.

bioreactors, chromatography skids, media or buffer preparation equipment, aseptic handling of mammalian cell culture,

conducting scale-up operations, etc.).

· Maintains files, records data, logs activities, and monitors processes

· Prepares process buffers, media and reagents.

· Cleans and Steam sterilizes equipment and maintains area in a clean and orderly fashion to support the manufacturing

schedule. 

· Maintains area in a clean and orderly fashion to support the manufacturing schedule. 

· Recognizes and reports safety, maintenance and quality events to area management. 

· Communicates status of operations to area management in a timely manner.

· Achieves and maintains proficiency through training.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc: 

· Prior job related experience required along with demonstrated mechanical aptitude and high level of attention to detail.

· Prior job related experience required along with demonstrated aseptic technique including manual dexterity, pipetting into

small vials and being able to close small caps in an aseptic manner is desirable.

· Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.

· Familiarity with general chemistry, mathematics, microbiology and cGMP operations is desirable.

· Work/study experience where attention to detail, adherence to written instruction, and personal accountability were critical

to success

· Demonstrates good interpersonal skills, is attentive and approachable with the ability to embrace a team based culture.

· Demonstrated ability to communicate expectations and results to the operating staff and management as needed to

maintain production timelines and organizational goals.  

Education/Experience/ Licenses/Certifications: 

The successful candidate will have a high school diploma.  Knowledge of science generally attained through studies resulting in a

B.S. in science, engineering, biochemistry, or related discipline or its equivalent is desired. Experience in aseptic technique and

mammalian cell culture is desired.  A minimum of 1 year of experience in biotechnology manufacturing facility or related industry

subject to current Good Manufacturing Practices (cGMP) regulations.

Physical Demands:  This position is located a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE).  This role will require contact with hazardous materials such as caustic, acids and steam.  Frequent bending, twisting, squatting, kneeling, climbing and reaching is required. Role also requires infrequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hand/wrists, grasping is also required.  This position is a team based position that requires shift work, weekends, holidays and overtime. Work Environment:  The work environment involves activities in a medium scale manufacturing facility, lab space and office space. The environment includes limited exposure to noise ( > 85 dBA), hazardous chemicals and equipment temperature extremes.

Travel:  ·

This position requires up to _0_% of travel

Supervisory Responsibilities: 

None

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Associate Manager, Regional Operations (AMRO) – Immunology (MS – West)

We are seeking an individual with a track record of strong leadership, compliant execution, and a winning mindset to join our Immunology Sales Operations team at our Princeton Pike Headquarters.  This individual will partner with the West Region Business Director (RBD) on all business related functions to continue the successful launch of Ozanimod in the US. The selected candidate will have a high level of exposure to senior sales and marketing leadership across our business unit and will be a key member of the operations team. 

Even more specifically, the successful candidate will excel at:

• Collaborating with RBD on the development and execution of the regional business plan and providing recommendations to improve regional sales performance  

• Leading the planning and execution of the West region’s communication plan, including regional meetings, e-mails, slide decks, teleconferences, and associated compliance/legal (PReP) review (e.g. RBD leadership meetings, regional POA meetings, etc.)
• Leading the inquiry/resolution process for field sales (e.g. triaging and following up on Clarity tickets created by DBMs, ad hoc requests from home office and field, etc.)
• Providing subject matter expertise on all sales systems (e.g. OneLook Specialty (OLS), Veeva/InterAct, Call Planning Process, e-Roster, HCP Connect, MS Teams, a:Coach, Inkling, SharePoint, p-value, Survey Monkey etc.)
• Tracking the allocation and utilization of resources (e.g. promotional program and D&E budgets, marketing materials, sample request forms, etc.) and region adherence to BMS policies and procedures
• Partnering with the home office operations team and necessary functional areas to troubleshoot regional operations issues (e.g. issues with OneLook, call planning, samples, Veeva/Interact, Targeting & Alignment, etc.)
• Providing proactive analysis of region and district performance
• Assisting with the new hire on-boarding process as it relates to operational analytical systems and business processes
• As needed, leads projects to support brand (e.g. field/tactical component to local professional society meetings or walks), roll out of new technology, and assist with POA planning

Qualifications

• 5+ years of pharmaceutical or relevant sales experience
• Well documented examples of strong leadership, strong compliant execution, and a winning mindset
• Demonstrated ability to deliver on sales objectives with a track record of strong sales performance
• Experience with MS / Immunology customer base and market industry knowledge preferred (but not necessary)
• Successful experience working with local sales matrix team to accomplish business objectives.
• Demonstrated experiences partnering with DBM to support the execution of approved brand tactics, onboarding of new representatives, and assisting with training sales skills and product knowledge
• Ability to impact and influence others with no direct reporting relationship
• Ability to communicate effectively and clearly
• Demonstrated planning and project management skills

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.