Senior Scientist - Principal Scientist, Analytical CMC Strategy

Job Description

PURPOSE AND SCOPE OF POSITION:

Bristol-Myers Squibb Global Cell Therapy Development Operations (CTDO) 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.

The Senior Scientist/Prinicpal Scientist will be the analytical lead for late stage and commercial Cell & Gene Therapy Products (CGTP) and gene delivery modalities including lentiviral vector. The Senior Scientist/Prinicpal Scientist will lead the post-commercial strategy for managing analytical method lifecycles, refining analytical control strategies, and developing analytical target profiles for new methods. The incumbant will also contribute to updates to the Specification (analytical procedures and acceptance criteria) and enable regulatory filing, including IND amendments, BLA fillings, responding to regulatory agencies, and drafting, reviewing, and approving documents that support filings. The Senior Scientist/Prinicpal Scientist will be familiar with CGTPs and CAR T cell therapy products, experienced in QC Release & Stability methods, have expertise implementing alternative compendial methods, and highly proficient in the latest FDA and EMA regulatory guidance on CGTPs.

The incumbent will be a member of a cross functional team responsible for the CMC strategy and lifecycle management of late stage and commercial CGTP. This position requires strong partnership and collaboration with multiple stakeholders including Process Development, Quality, Regulatory, Manufacturing Sciences and Technology, CMC Strategy and LCM.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

Senior Scientist: A PhD, MS, or BS in Biology, Cell Biology, Biochemistry, Immunology, Virology or related disciplines with at least 4, 10, or 13 years of industry experience in relevant fields, respectively.

Principal Scientist: A PhD, MS, or BS in Biology, Cell Biology, Biochemistry, Immunology, Virology or related disciplines with at least 8, 12, or 15 years of industry experience in relevant fields, respectively.

Experience

Qualifications and Education Requirements

• CMC team experience. Demonstrated knowledge of and analytical development and control strategy for CMC programs to support post-commercial method life cycle management
• Broad expertise and knowledge in analytics routinely used for in-process, release, and stability testing of CGTPs, and specifically, CAR T cell therapies
• Experience in product characterization and strategies to establish process and product knowledge.
• Proficient in ICH, FDA, EMA, and JP regulations and guidance
• Expertise in USP, EP, JP, etc. regulations and guidance
• Experience in drafting, reviewing, approving, and supporting regulatory filings, including IND amendments, BLAs, and regulatory responses
• Demonstrated collaboration skills working cross functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.
• Outstanding written and oral communication skills
• Work effectively in a collaborative team setting
• Ability to work in a rapidly changing environment with frequent changes in priorities
• Experience with MS Office suite of software

Preferred Qualifications

• Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software.
• Understanding of tools and methods of statistical analysis of stability data

DUTIES AND RESPONSIBILITIES:

The Senior Scientist/Principal Scientist will be an individual contributor, leader of a matrix team of analytical scientists, and a contributor on the CMC team. The Senior Scientist/Principal Scientist will collaborate across BMS sites with Analytical Development, Manufacturing Science and Technology, Product Quality Leads, CMC teams, and Regulatory leads to generate and execute commercial strategies for methods and specifications, analytical control strategies, and support of product lifecycle regulatory filings. This position will be located at the Bristol-Myers Squibb site in Seattle, Washington.

WORKING CONDITIONS (US Only):

• Office and laboratory environments with a mix of natural and LED lighting with low level of background noise. Required computer and conferencing hardware are provided. 40% seated at a desk with ergonomic and sit/stand desks and 60% time in laboratory or meetings.
• Local, national, and international travel up to 10%
• 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.