Product Analytical Strategy Lead- Cell Therapy (R1557590-en-us)
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.
The Product Analytical Strategy Lead will drive technical strategy, knowledge and deliverables related to cellular drug product development that are required for Chemical Manufacturing Control (CMC) program milestone achievement. The ideal candidate has a proven track record of technical proficiency, experience with matrix team leadership, product analytical strategy, understanding of technical capabilities of contract manufacturing organizations and contract test laboratories and demonstrated skillset/knowledge of analytical development. This position will serve as Product and Analytical Development (P&AD) department single point of contact for technical aspects of a program and lead analytical strategy in a matrix team supporting product release, characterization and in-process testing of cellular drug product.
- Develop actionable strategies and plans that ensure alignment with short-term and long-term objectives developed in tandem with P&AD leadership.
- Direct analytical strategy implementation, resources and overall project execution
- Work with P&AD department and functional partners to build cellular process and product understanding that serves as a foundation of the analytical strategy
- Partner with P&AD, Process Development, Quality, Manufacturing leaders to foster cross-functional collaboration and appropriate alignment
- Exemplify and drive technical excellence through portfolio analytical strategy development and advocacy
- Contribute to DP analytical risk identification, assessment and mitigation
- Ensure strategy/status/summary data/issues/plans for functional areas are presented at relevant meetings and governance board
- Accountable for drug product specifications and justification of specifications for clinical programs
- Serve as author/reviewer for analytical sections of CMC submissions and responses to regulatory questions
Qualifications & Experience
- Ph.D. or Master degree in analytical sciences or related fields with minimum 5 (for Ph. D.) or 8 (for Master) years of experience in the development and approval of cell & gene therapy products or biologics or other relevant fields.
- Extensive experiences with CMC analytical strategy and demonstrated technical proficiency.
- Demonstrated ability to attention to scientific details and to multi-task in a high paced environment
- Extensive experience and knowledge with engineered T cells and gene editing technologies are preferred
- Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships and influencing scientific rigor
- Demonstrated ability to draw insights from large data quickly, perform analysis, and present scientific rationale.
- Experience in authoring technical and Regulatory documents. Experience in drafting, reviewing, approving and supporting regulatory filings including IND amendments, BLAs, briefing books, and regulatory responses.
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.
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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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