$200K — $250K *
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 Senior/Principal 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/Principal 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/Principal 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:
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.
Qualifications and Education Requirements
DUTIES AND RESPONSIBILITIES:
The Senior Senior/Principal Scientist will be an individual contributor, leader of a matrix team of analytical scientists, and a contributor on the CMC team. The Senior/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):
Valid through: 8/6/2020
$100K — $150K
22 days ago