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Bristol-Meyers Squibb, Co.

Principal Scientist/Sr Principal Scientist GDE analytical strategy

Pharmaceuticals

All

Full Time

On Site

No

Seattle, Washington, United States

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.

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.

Bristol-Myers Squibb (BMS) is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

Gene Delivery Product and Analytical Development (GDPAD) leadership seeks applicants for the Product and Analytical Lead role to drive strategy and deliverables related to lentiviral, AAV vector, RNP and raw materials analytics development that are required for CMC milestone achievement of clinical program. The ideal candidate has a proven track record in matrix team leadership, CMC strategy, relationship-building with contract manufacturing organizations (CMOs) and contract test laboratories (CTLs), with a demonstrated skill set/knowledge of analytical development. This is a highly visible role that will serve as the GDPAD single point of contact for program vector analytics strategy, for CMOs/CTLs, and across our partner organizations (Process Sciences & Technology, Drug Product Development; Product and Analytical Development, Quality, Regulatory, Program teams). The candidate will be accountable for the analytical strategy that supports QC release, characterization, and in-process testing of viral vectors used for CART and/or TCR gene deliver. The candidate will lead a cross-functional team to deliver vector characterization and QC release assays, successfully transfer methods to CMOs and CTLs, and coordinate the qualification thereof.

This position requires CMC strategy experience, project and cross-functional leadership skills, prioritization and technical writing, attention to scientific detail and ability to multitask in high-paced environment.

Responsibilities:

  • Lead the development of vector control strategy within a cross-functional team in support of clinical engineered T cell programs. Establish phase appropriate analytical development, characterization, and release strategies related to vector, RNP or raw materials that is aligned across cellular therapeutics programs.
  • Manage CMO/CTL relationships to ensure development and qualification of appropriate analytical methods to enable vector process development, release and stability testing at CMOs/CTLs
  • Work with Process and Analytical Development (P&AD) departments and cross functional partners to build vector process and product understanding that serves as the foundation of the analytical strategy including establishing and iterating QTPP, CQAs, and specifications throughout development.
  • Establish a flexible and agile matrixed P&AD team that supports both line function and program deliverables. Lead this team to ensure on-time CMC deliverables. Summarize and present data in cross-functional team meetings
  • Partner with process development and provide vector technical expertise required to support vector and drug product process development.
  • Contribute to regulatory submissions
  • Accountable for CMC analytical data– type, documentation, integrity, organization, and integration of datasets with cross functional partners for development needs and resource allocations.
  • Develop and implement planning tools required for timely communication, efficient prioritization, and resource allocation.
  • Identify the opportunities for, and drive alignment of best practices in policy and strategy across GDPAD and P&AD departments areas to streamline practices and increase efficiencies

Basic Qualifications:

  • Ph.D. degree in virology, analytical sciences, or related field with experience with CMC strategy and/or drug development
  • Experience interfacing with GMP contract test laboratories and contract manufacturing organizations
  • Demonstrated experience in cross-functional and functional leadership roles.
  • Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.
  • Experience authoring technical and regulatory documents. Experience in drafting, reviewing, approving, and supporting regulatory filings, including IND amendments, BLAs, and regulatory responses
  • Proficient in ICH, FDA, EMA, and JP regulations and guidance.
  • Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects.
  • Strong interpersonal skills including verbal and written communication are essential in a collaborative work environment.

If you have a passion for taking on new challenges in a fast-paced and dynamic environment, are dedicated to excellence and want to make a difference, we're excited to hear from you! The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge of viral vectors, in gene editing, analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.

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.

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