Principal Scientist, Analytical Development, Cell Therapy

Bristol Myers Squibb•Seattle, WA

16d•$127,000 - $159,000

About The Position

We are looking a highly motivated and self-driven professional to join our Cell Therapy Analytical Development (CTAD) department as a Senior or Principal Scientist. The successful candidate will play a crucial role in developing, validating, transferring, and troubleshooting plate-based assays to advance cell therapy development deliverables. The highly experienced assay developer will independently develop and execute plate-based assays to support process development, as well as the characterization and release of autologous and allogenic cell therapies which are undergoing clinical trials. The Senior/Principal Scientist will design and analyze experiments with minimal supervision, leading to the development of robust analytical methods. They will be responsible for developing QC methods for lot release testing, characterization methods for product understanding, and routine testing to support process development and comparability assessments. The Senior/Principal Scientist should possess significant hands-on experience in ligand binding/antibody assay development and demonstrate capability in collaborating with other groups, such as discovery research, product sciences, process development, and QC. Additional preferred experience includes working in a cGMP environment and/or performing analytical method validation and transfers to a QC facility. The ideal candidate will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of like-minded Scientists. This is a lab-based position, with the level commensurate with experience.

Requirements

A PhD with 5+ (BS with 12+) years of experience in pharmaceutical research, development, or related industry experience.
In-depth knowledge and hands-on experience in development and validation of ligand binding assays (e.g., ELISA, MSD, AlphaLISA, Simple Plex, Luminex).
Proven experience with data analysis and interpretation using software (e.g., Softmax Pro, Gen5, MSD Workbench, Excel).
Ability to work effectively in a collaborative team setting and in a rapidly changing environment with frequent changes in priorities, which require strong organizational skills.
Strong written and oral communication skills.

Nice To Haves

Experience in cGMP environment is a preferred.

Responsibilities

Act as subject matter expert to develop, optimize, validate, and troubleshoot assays used for vector and cell therapy products.
Design and execute phase appropriate validation, and manage method transfer from CTAD to internal or external QC/testing groups.
Maintain meticulous laboratory notebooks and manage routine sample analysis requests.
Represent the group and present data to cross functional meetings.
Author, review and approve technical documents, including methods, protocols, reports, and regulatory submissions.
Good knowledge of cGMP and ICH/FDA/EMEA guidance.
Facilitate smooth operation of the laboratory, including ordering, assisting in the cryopreservation of cellular material, sample management, etc.
Complete regulatory, site, and department training requirements on a timely basis.

Benefits

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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