Manager, Drug Product and Viral Vector Life Cycle Management Cell Therapy

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 Cellular Therapies, Quality organization is seeking a Manager who will be responsible for analytical lifecycle activities to support Cell Therapy drug product and vector programs. Reporting into the commercial Analytical Sciences & Technology (AS&T) function, this role is accountable for managing analytical life cycle activities with a focus on coordination of method transfer and validation activities.

Responsibilities:

• Represent the AS&T function on tech transfer teams as the method transfer lead for drug product and vector programs.
• Partner with internal analytical teams to manage method transfer and validation activities at external, contract testing labs as well as internal QC labs.
• Create project plans, monitor progress, identify risks to project deliverables, and communicate progress to project leadership.
• Function as the Quality liaison with contract test labs during QC investigations.
• Coordinate internal cross-functional team members on project deliverables to maintain overall project timelines.

Qualifications and Education Requirements

• BS in relevant scientific discipline and 5+ years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy organization. Work experience within a commercial QC organization is preferred.
• Knowledge of analytical method lifecycle, including assay transfer, validation and maintenance. Experience with implementing release methods in a commercial QC facility is required.
• Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, vaccines and/or biological products.
• Excellent verbal and written communication skills and the ability to work effectively at a fast pace will be an asset.
• Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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