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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.

Job Description

Duties and Responsibilities:

• Oversee day-to-day operations in a QC laboratory, providing both technical and operational oversight to the lab, for effective operation of the biologics manufacturing facilities at Devens and/or the Global Biologics Network.
• Subject matter expert with methodologies associated with the Chemistry QC lab.
• Execute troubleshooting techniques independently, and help support junior analysts.
• Trainer for multiple methodologies within the lab area of focus.
• May perform routine testing to support team in times of elevated testing volumes.
• Investigate out-of-specification results and leads low risk deviations. Execute routine cGMP compliance in all aspects of assigned laboratory operations.
• Author/lead revisions to SOPs for managerial review and approval.  Author protocols/reports as required
• Provide technical leadership to the assigned QC laboratories. Serve as Subject Matter Expert in cross- functional / cross-departmental work teams, and participate in site team supporting and managing regulatory inspections and findings.
• Participate on method transfer teams, including performing lab work required to support method transfers or validations for assigned QC lab.
• Lead continuous improvement efforts within assigned lab. Evaluate and suggest improvements to standard methods/procedures/processes. Support data trending, analysis and reporting of team KPIs.
• May represent QC on site or network project teams.
• Develops methods and procedures, to ensure compliance with corporate policies and procedures.
• Reviews data obtained for compliance to specifications and reports abnormalities.
• Back up to Lab manager

Knowledge and Skills:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred
• Minimum of 6 years of experience as a senior analyst in Biologics QC lab or GMP laboratory.
• Operational knowledge  of some or all of the following analytical methodologies: Appearance (color/clarity/visual particulates), Free Thiols, Protein Concentration, and particle analysis procedures (HIAC, Semi-quantitative )
• Experience with LIMS and Smart lab computer applications a plus.
• Proficient in common computer software applications.
• Strong general laboratory and organizational skills, effective communication skills, both oral and written.
• Extensive knowledge of regulatory requirements (e.g., US, EU, USP) and industry best practices. Prior experience supporting regulatory agency inspections preferred.
• Demonstrated ability to schedule and plan work for a team a plus
• Demonstrated interpersonal, communication, and problem solving skills. Strong attention to detail.
• Previous method transfer/validation experience desired.
• Operational Excellence experience

Contacts:

• Incumbents have daily interaction with their staff and other members of the site Quality organization.  Associate Scientists may interact with any employee at any level of the Devens Facility, with daily interactions with other departments on site.  Occasional contact with outside vendors and infrequent contact with representatives from health authorities / regulatory agencies.

Working Conditions:

• Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.  Work may include night shift or weekend assignments.

Decision Making:

• May work on assignments that are basic in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.  Exercises judgment within specifically defined practices and policies in selecting methods and techniques for obtaining solutions.  Coordinates with higher level managers on decisions, and applies appropriate notification to management as appropriate.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays.

Supervision:

• Receives assignments in the form of objectives and establishes goals. Determines and develops an approach to solutions, with input from supervisor/manager. Provides guidance to subordinates to achieve goals in accordance with established policies.  Work is reviewed and measured based on meeting established objectives and schedules.  Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
• Oversees and provides guidance to non-exempt staff as required in daily laboratory procedures.
• No formal supervisory responsibilities

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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 biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  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.

Responsibilities:

• Work cross-functional and globally as required to support the country, region and/or products assigned.
• Works under the guidance of the International Labeling Operations Lead or with Senior Specialists
• Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.
• Notifies appropriate groups or changes or recent source/reference labeling approvals.
• Prepares country-specific labeling in support of safe and appropriate use of BMS products for in-scope countries; maintains country specific translation mastercopy to meet labeling responsibilities.
• Prepares, tracks, maintains and reviews required labeling documents (e.g. physician’s label, patient insert, carton, label, blister, tenders) using Text verification Tools, PRISM / CARA workflow and additional software or process tools to maintain change history for all labeling documents.
• Ensures all labeling supporting documentation and final approved labeling documents (HA approved content and final artwork) match, are status updated and tracked in the electronic data management system or systems.
• Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
• Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives as needed of upcoming changes to labeling and provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.

Required:

• Bachelor’s degree - or Master’s Degree, preferred in sciences with 2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.*
• Must possess an excellent command of language (English) and professional knowledge of medical terms,
• Good communication and organizational skills and a meticulous eye for details
• Good understanding of pharmaceutical or medical terminology
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed
• Experience working on multi-disciplinary teams and projects
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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.

Summary:

The Director Strategy & Operations shall work closely with the Head of Strategy & Operations to drive key regional priorities and strategic projects. This individual shall closely collaborate with local markets, the Intercon Leadership Team as well as WW stakeholders, to ensure robust launch planning, capability enhancement, commercial model evolution, and overall business performance.

Key Role Accountabilities:

• Support 5 year Intercon Strategy execution including:

  • Assessment of local and global op model, capabilities, and resources needed to deliver on growth

  • Securing commitment for early consideration of global pipeline

• Collaborate with Worldwide Brand Teams to:

  • Ensure Intercon markets are included in launch footprint

  • Prioritize Intercon markets for regulatory submission, resources, and engagement

  • Tailor Worldwide strategy for priority markets

  • Ensure robust pre-launch and launch planning activities

• Collaborate with Worldwide Value, Access, and Payment to:

  • Evaluate access & pricing strategy adaptations to meet unique challenges of Intercon priority markets

  • Enhance op model, resources, and local capabilities

• Monitor achievement of portfolio sales goals and OPEX efficiency through partnership with finance and BI&A on business reviews, budget presentations, and region analytics

• Support operational excellence by:

  • Coordinating the development and roll out of region objectives and talent review timing

  • Managing market visit scheduling and agendas to ensure engagement with key markets

  • Coordinating congress activities to ensure appropriate representation and engagement from leadership

• Lead Intercon S&O forum to facilitate shared learnings across markets. Define regional S&O priorities and work with market S&O leads to pull through region strategy

Experience Desired:

• 6+ years experience

• Strong analytics, finance background

• Marketing, sales, medical, or operations experience preferred

• Consulting/strategy experience preferred

• Demonstrated ability to develop meaningful and trusted relationships with all levels of an organization

• Demonstrated ability to effectively communicate ideas and influence others to accomplish goals and objectives

• Proven ability to use resources effectively to overcome challenges and complexities and achieve business objectives

• Proven ability to bring strategy and analysis to a tactical, executable level; results-oriented

• Demonstrated ability to work in a fast-paced, changing environment and design and implement multiple projects simultaneously

• Demonstrated ability to partner, lead, and influence cross functional teams virtually

Minimum Requirements/Knowledge Desired:

• Candidate must have a BA/BS degree or equivalent; MBA is preferred

• 6+ years of Pharmaceutical Management/Leadership experience

• Consulting skills/ impact and influence abilities/ strong stakeholder management skills

• Excellent written and verbal communication skills, strong analytical, problem-solving, interpersonal, planning and organizational 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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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.

• Duties and Responsibilities:
• Performs routine testing and data review of raw materials, in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant environment.
• Executes routine procedures based on methodologies/responsibilities of the specific QC sub-team.  Assignments are made in the LMS, by the hiring manager, based on applicable curricula map(s).
• Author revisions to SOPs for managerial review and approval.
• Trained on multiple methodologies, and provides support to a broader spectrum of testing responsibilities.
• Executes troubleshooting techniques with guidance of supervisor or senior team members.
• SME on specific methodology.
• Trainer for specific methodology, responsible for training less experienced analyst on assay of expertise.
• May support qualification and validation testing for QC methods in area of expertise.
• May lead investigations for sub-team.
• Knowledge and skills:
• Knowledge of science generally attained through studies resulting in a BS degree, preferably in Chemistry, Molecular Biology, or related discipline.
• A minimum of 4 years experience in cGMP Biologics QC Laboratory or related cGLP or cGMP lab.
• Experience in analytical test methods such as  UV/Vis, Osmolality, pH, Appearance testing, Karl Fischer moisture analysis is highly preferred.
• Attention to detail and demonstrated organizational skills
• Ability to work independently as well as part of a team, to complete assignments within defined time constraints
• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
• Ability to execute problem solving with support of area lead or management.
• Proficiency with basic electronic system (email, MS Office, etc.)
• Experience with LIMS and ELN computer applications preferred.
• Work Environment:
• Will work in teams and have continual interaction with members of his/her team as well as other sub-tems within QC, in order to exchange information regarding testing completed, in process and planned.
• Daily contact with her/his supervisory staff for work assignments. Routine contact with supervisor for coaching and general performance management discussions.
• Occasional contact with other line management staff relating to specific project responsibilities may be expected.
• Specialist primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.
• Overtime work may be required on weekdays, weekends, holiday, and during adverse weather conditions in support of manufacturing facility.
• Decision Making:
• Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending corrective action.
• Supervision:
• Incumbents normally receive general instructions on routine work and general instructions on new assignments.
• No direct supervision, but the Specialist will be expected to participate in the training of less experienced staff in normal operational task.

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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:
The Incoming Lab Analyst is responsible for sampling, testing of all components (Printing, Packaging, Medical Devices, Material Requirement Sheet (MRS), Sterile materials) and sampling of all excipients, drug substances and API for the use of the manufacturing and packaging areas to assure compliance of applicable regulations per EU, Japan, Brazil and FDA requirements.
1.    Performs sampling and inspection for raw materials (RM) / excipients / Active Pharmaceutical Ingredients (API) / Drug Substances (DS). 
2.    Performs sampling of retain samples for raw materials and drug substances to fulfill retain sample program requirements.
3.    Performs sampling, inspection and testing for packaging components, including visual, dimensional and functional tests.
4.    Performs inspection and sampling (when applicable) for sterile materials, sterile garments and material requirement sheet.
5.    Supports Material/Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable).
6.    Performs investigations of non-conforming results and resolution of investigations.
7.    Performs and reviews required testing of materials and products in accordance with BMS specifications and/or applicable compendia. 
8.    Performs the disposition of packaging components according to results obtained.
9.    Processes and reports analytical data utilizing computer systems (e.g. TrackWise (TW), Infinity, Maximo, Ariba, SAP, LIMS, Scan TVS Proof Reader, Vision System, Bluehill Software, etc.) and verifies data generated by other peers. Issue change request to create new items in LIMS system.
10.    Operates laboratory equipment, such as: Ruler, Caliper, Instron, Optical Comparator, Vision System, Scan TVS, Barcode Reader (Cognex), Micrometers, gauges, Go-No Go gauges and others.  
11.    Recommends and make changes to documents such as:  SOPs, protocols, methods, work instructions, operational procedures, etc.
12.    Monitors laminar flow hood sample area parameters (e.g., humidity, temperature, differential pressure, etc.) and communicates excursions to supervisor.
13.    Participates in process validation, laboratory equipment qualification, and analytical method transfers. 
14.    Coordinates with Microbiology and /or Analytical Laboratory the required testing corresponding to Active Product Ingredients, excipients and packaging components.
15.    Coordinates sampling and sample delivery to outside laboratories for testing that cannot be performed in-house.
16.    Provides training to new members on applicable OJT, tasks and SOPs.
17.    Ensures that approved validated methods and specifications, robust system and adequate facilities are used to perform requires testing for RM, API, Excipients, Drug Substances, Packaging Components among others.
18.    Assures to be qualified in the use of Incoming Laboratory equipment and that the Incoming equipment is formally qualified before releasing materials such as RM, API, Drug Substances, Excipients, Packaging Components among others. 
19.    Assures to be formally qualified before performing any release testing of materials.
20.    Verifies consistency with other site procedures and/or specifications and verifies compliance with BMS Policies and Guidelines.
21.    Performs adjustments in SAP system to maintain inventory and change material status in SAP according to applicable procedures.
22.    Performs cleaning on API and Raw Materials Rooms.
23.    Generates Work order in Maximo system for equipment repairs, facility repairs, etc.
24.    Tracks materials status through the QA 33 report from SAP to maintain Incoming Attainment metrics within business goals.
25.    Participate in daily Tier 1 meeting.
26.    Execute approve supplier list verification against SAP system.

Knowledge/Skill:
•    Bachelor’s degree in Natural Sciences 
•    One (1) year of experience within Quality Control Laboratory in a Pharmaceutical Industry.
•    Working knowledge of computer and appropriate software packages. (e.g., Trackwise, SAP, LIMS and Microsoft Office (Word , Excel, Power Point), 
•    Knowledge to collect and document data and or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.).
•    Ability to perform basic troubleshooting of Incoming Laboratory equipment including but not limited to system check, setting and daily verification. 
•    In-depth knowledge in the use and interpretation of Testing Standards and a working knowledge of QC SOP’s, cGMP’s, federal and other countries regulatory requirements.
•    Ability to conduct a variety of analytical techniques including but not limited to visual, dimensional and functional tests for packaging components.
•    Knowledge of cGMPs, EU and other regulatory requirements.
•    Basic mathematical, statistical, and analytical skills.
•    Thorough understanding of cGMP and laboratory documentation procedures (e.g., good documentation practices, SOP’s, etc.).
•    Knowledge of sampling plans (e.g., ANSI/ASQ Z1.4 /Z1.9).
•    Knowledge of the SAP System.
•    Proficiency in oral and written communication skills both English and Spanish.
•    Good organizing and planning skills.
•    Capacity to use Safety Respirator and capacity to perform the Safety gowning.
•    Disposed to work irregular hours, rotation shifts, weekends, and holidays, when necessary
•    Inspection tasks require 20/20 visual eye accuracy and color detection with or without correction
 

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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.

Scientific Director, Discovery Analytical Sciences, Leads Discovery and Optimization

Leads Discovery and Optimization (LDO) is a dynamic organization that supports the entire continuum of drug discovery from lead identification to clinical candidate delivery at Bristol Myers Squibb. LDO leverages state of the art technologies, complemented by deep subject matter expertise and broad scientific knowledge, to deliver innovative and comprehensive preclinical in vitro datasets to support our drug discovery pipeline in disease areas such as oncology, immunology, fibrosis, cardiovascular diseases, and cell therapy. 

The role of Scientific Director, Discovery Analytical Sciences presents an exciting and challenging opportunity for an experienced senior-level scientist and mentor with broad and in-depth experience implementing biophysical solutions to support small molecule drug discovery. Persuasive communication and strategic thinking will be essential to understand the needs of biologists and chemists and guide them towards appropriate strategies to triage and advance compounds. The Scientific Director, Discovery Analytical Sciences will lead a team responsible for deploying a variety of biophysical techniques (TSA, SPR, ITC, MST, etc.) and advanced mass spectrometry platforms (RapiFlex, LC and SAMDI affinity selection MS) for lead discovery, target engagement confirmation, mechanistic profiling, and molecular characterization.

Responsibilities:
•    Lead Discovery Analytical Sciences team of 10 or more experienced scientists and contractors based in Lawrenceville NJ
•    Manage a large portfolio of programs across all therapeutic areas consistent with LDO portfolio strategy and priorities 
•    Prioritize screening (fragment-based lead discovery, covalent binding screens, and affinity selection MS) and compound profiling (target engagement, binding kinetics and thermodynamics, mechanism of action) activities across biophysical and mass spectrometry platforms
•    Provide mentorship and career development opportunities to all team members; foster an environment that promotes cross-functional collaboration and creative problem solving
•    Report to Head of Automation and Assay Technologies as part of leadership team comprising automation and HTS, compound management, data sciences, and high-content screening
•    Represent biophysical and mass spectrometry solutions in collaborations with project teams and in LDO leadership discussions
•    Serve as key contact with Contract Research Organizations and other collaborators; enable efficient use of external resources to complement internal efforts
•    Evaluate technology solutions and scientific advances; engage innovators and vendors to create and implement a vision for future growth

Qualifications:
•    Ph.D. in biophysics, biochemistry, or related subject with 10+ years of experience mentoring and leading teams in pharmaceutical or biotechnology companies or B.S./M.S. with extensive pharmaceutical/biotech industry experience
•    In-depth knowledge of biophysical techniques, scientific principles of molecular interactions, and binding kinetics and thermodynamics
•    Experience in biophysical characterization of protein reagents to assess solution state properties including folding, thermodynamic stability, and aggregation behavior
•    Experience with the application of mass spectrometry to compound screening (e.g., affinity selection MS, SAMDI)
•    Working knowledge of NMR methods to study protein-ligand interactions to inform collaborative projects with NMR group
•    A consistent track record of scientific achievement and communication demonstrated by publications and presentations
•    Experience working in a matrixed, distributed organization, and with external partners

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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.

• Lead, develop, implement and perform quality monitoring activities with respect to Safety Aggregate Reports (SARs) for Worldwide Patient Safety (WWPS)
• Work with Safety Aggregate Reports Global Process Owner and Global Process Leads in developing, implementing and conducting quality monitoring and compliance monitoring programs
• Develop and monitor Key Performance Indicators to determine thresholds to trigger potential Deviations for the purpose of continuous quality improvement
• Work with the Inspection Readiness and Deviation management team members to investigate issues, review quality trends
• Contribute toward the management of SAR quality monitoring related procedural documents and training relating to core responsibilities as needed
• Contribute Safety Aggregate Report related quality monitoring results, trends, deviations and remediation actions as needed in the GVP Quality Council (quality system management governance) and the Pharmacovigilance Master File
• Maintain an in-depth knowledge of global pharmacovigilance regulations that impact the research, development and marketing of medicines and devices as well as relevant Bristol-Myers Squibb Company policies and procedures 
• Within the area of expertise, maintains awareness of industry trends and developments
• Contributes to WWPS inspections and audits both proactively in terms of readiness preparation and post-evaluation ensuring implementation of corrective and preventative actions within areas of expertise.

Requirements:

• Minimum of a Bachelor's degree required
• Minimum of eight years pharmaceutical industry experience, including 5 years of pharmacovigilance, drug development, clinical development or regulatory affairs experience.
• Strong scientific background in a life science related field
• Prior quality monitoring experience in pharmacovigilance
• Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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 biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  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.

Responsibilities:

• Work cross-functional and globally as required to support the country, region and/or products assigned.
• Works under the guidance of the International Labeling Operations Manager or with Senior Specialists
• Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.
• Notifies appropriate groups or changes or recent source/reference labeling approvals.
• Prepares country-specific labeling in support of safe and appropriate use of BMS products for in-scope countries; maintains country specific translation mastercopy to meet labeling responsibilities.
• Prepares, tracks, maintains and reviews required labeling documents (e.g. physician’s label, patient insert, carton, label, blister, tenders) using Text verification Tools, PRISM / CARA workflow and additional software or process tools to maintain change history for all labeling documents.
• Ensures all labeling supporting documentation and final approved labeling documents (HA approved content and final artwork) match, are status updated and tracked in the electronic data management system or systems.
• Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
• Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives as needed of upcoming changes to labeling and provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
• Maintains an understanding of regulatory labeling requirements of assigned region or countries.

Required:

• Bachelor’s degree - or Master’s Degree, preferred in sciences with 2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.*
• Must possess an excellent command of language (English) and professional knowledge of medical terms,
• Good communication and organizational skills and a meticulous eye for details
• Good understanding of pharmaceutical or medical terminology
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed
• Experience working on multi-disciplinary teams and projects
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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.

The BMS Immuno-Oncology and Cell Therapy Thematic Research Center is dedicated to research supporting development of novel cellular therapies.  Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

The CAR and TCR Biology team is seeking a highly motivated immunologist to help us deliver on this critical goal.  The successful candidate will innovate preclinical in vitro methods for identification and optimization of lead T cell therapeutic candidates.  The ideal candidate will have in depth conceptual understanding of tumor-associated T cell biology and be able to identify relevant assays, as well as recognize the need for novel technologies, for assessing functionality of the engineered T cells.

Responsibilities include and are not limited to:

o   Identification and conception of novel methods and tools for improving the T cell characterization workflow and for improving functions of engineered T cells; apply science-driven decision making on complex problems.

o   Designing and executing studies required to drive hypothesis-driven research, through interpretation and synthesis of available data sets.

o   Application of extensive knowledge of T cell biology including activation pathways, signaling pathways, and T cell differentiation.

o   Managing and/or coordinating workflows in projects.

o   Timely communication of study design and data in verbal and written forms; provide well prepared data packages for internal team meetings, external scientific reports, patent applications, and Investigational New Drug applications.

o   Act as a functional mentor to team members, especially more junior colleagues.

o   Represent the project team/sub-team in meetings.  Work with collaborators, both external and internal.

Qualifications:

o   Ph.D. in immunology, immune-oncology, or tumor immunology, with a successful publication record and 2+ years of post-doctorate, drug R&D experience in industry.

o   Experience with in vitro technologies typically employed to assess T cell functionality, including, and not limited to MSD, IncuCyte-based assays, imaging and multi-parameter flow cytometry for immuno-phenotyping, T cell activation and proliferation analysis.

o   T cell biology expertise, able to apply skills, experience, and theoretical knowledge from relevant literature to shape scientific direction and approach on projects.

o   Able to recognize problems and then recommend/develop appropriate solutions, to iteratively test specific hypotheses or innovate through a series of related experiments.

o   Self-motivated and focused, with project management-oriented thinking and growth-oriented mindset.

o   Ability to work productively both as team member and as individual contributor.

o   Strong interpersonal skills for working with cross-functional teams.  Good at listening to and coordinating with colleagues in a matrix environment.

o   Strong organizational and prioritization skills to ensure thorough and timely documentation of experiments, as well as preparation of data for compiling reports.

o   Able to conceptualize broader impacts of personal activities on projects and teammates.

Additional desired qualifications:

o   Bioinformatics experience with NGS or related data sets.

o   Candidates with scripting experience in R, Python and/or MATLAB for data-driven analytics are preferred.

o   Assay development experience with CAR T or TCR T cells.

o   Experience with high throughput screens, CRISPR screens, high-throughput functional T cell analysis, and experimental automation.

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. 

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

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.

Representante de Alta Especialidad de preferencia en el Área de Oncología que domine el mercado Público y Privado en León Guanajuato, con conocimiento de inclusiones en Cuadros Básicos, relación con Distribuidores y con alto desempeño en ventas de drogas huérfanas y /o productos de Alta Especialidad. 

Implementará planes estratégicos para aquellas cuentas claves del territorio asignado. Es el principal punto de contacto con el cliente/médico, creará una relación de socio con clientes claves, construirá relaciones sostenibles y se apoyará con información del cliente de tal forma que se puedan generar soluciones, propuestas de valor y estrategias para encontrar o solucionar necesidades no satisfechas o evolucionar nuevas oportunidades. Además, en su territorio deberá buscar y desarrollar nuevos clientes/médicos potenciales. 

Responsabilidad

• Promoción y venta de los medicamentos oncológicos bajo su responsabilidad, (Opdivo y Yervoy )

• Implementación del plan táctico diseñado para los productos bajo su responsabilidad

• Posicionar a BMS como compañía líder en Inmuno Oncología en México

• Iniciar y Mantener Planes Comerciales con Médicos, clientes, cuentas claves de su territorio asignado

• Participación activa en el diseño de estrategias de marketing y acceso, para la indicación bajo su responsabilidad.

• Desarrollo del plan táctico, para su territorio y cuentas claves

• Identificación oportunidades de mercado, manteniendo un conocimiento profundo y acercamiento con sus clientes.

• Apego , seguimiento y cumplimiento de políticas y procedimientos de BMS

• Asegurar cumplimiento de los objetivos de venta

Habilidades, Competencias y Conocimientos

• Conocimiento del mercado de Oncología y alta especialidad

• Relación estrecha con líderes de opinión y prescriptores

• Manejo de Office, auditorías de mercado y otros (Excel, PowerPoint, Base de Datos)

• Conocimiento y experiencia en promoción y manejo de productos de Inmuno oncología

• Solido conocimiento del mercado oncológico en México

• Capacidad de relacionamiento y trabajo en equipo

• Excelentes relaciones interpersonales Capacidad de negociación

• Capacidad de trabajo bajo presión

• Capacidad de planeación, organización y control de sus actividades.

Requiere viajar: Si

indispensable radicar en León, Guanajuato.

Educación: Licenciatura en áreas afines a Salud y/o Administrativas Experiencia: Experiencia mínima de 5 años en la industria farmacéutica en el área de Ventas de Oncología.

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.