Scientist/Sr. Scientist - PD&MSAT
Germantown, MD
Full Time
Experienced
About the job
We are looking for a scientist/Sr. Scientist to join our Cell Therapy Process Development & Manufacturing Science & Technology (MSAT) team. In this role, you'll be instrumental in supporting the manufacturing process of cell therapy products. This is an opportunity to work with curious minds in an inclusive culture, where you'll be evaluating process and technology improvements, contributing to process understanding and characterization, and providing manufacturing support and technology transfer in a cGMP environment.
Position title
Scientist/Sr. Scientist
Role:
The role will be responsible for tech transfer, implementing, and executing manufacturing processes for cellular therapy programs. This role will receive tech transfers, implement them into our in-house GMP manufacturing facility, and be a hands-on operator for the manufacturing campaign. This role requires extensive collaboration with internal and external teams. The successful candidate will need a strong scientific background, interpersonal skills, and the ability to work collaboratively with internal and external teams.
Responsibilities:
- Leads, and executes laboratory- based activities in supporting the tech transfer of new equipment and processing steps into GMP manufacturing.
- Leads and executes at-scale end-to-end runs in the PD labs to demonstrate process manufacturability and generate materials to support clinical trials.
- Lead technology transfer to internal manufacturing facility by collaborating with cross-functional teams, e.g., MFG, QA, QC.
- Develops and reviews SOPs, MFG batch records.
- Serves as the primary MSAT subject matter expert in support of GMP manufacturing, facilitates manufacturing decision-making, problem-solving process.
- Manage and maintain the routine operation of the process instrument.
- Prepare progress reports, technical reports, and other status updates to other functional leads.
- BS degree in Pharmaceutical Sciences, Biomedical Engineering, Pharmaceutics, or related field with a minimum of six (8) years OR MS degree with a minimum of four (5) years OR PhD with a minimum of two (2) year of relevant proven experience.
- Hands-on experience in cell therapy process and analytical assay development.
- Hands-on experience with automation equipment used for cell therapy manufacturing: G-Rex, Prodigy, LOVO, etc.
- Proficient in laboratory skill sets including aseptic techniques, cell culture is required.
- Experience in analytical techniques for cell therapy, such as flow cytometry, ELISA is highly preferred.
- Experience in technical development of cell and gene therapy or biologics in early and late-stage development settings.
- Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations.
- Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
- Highly organized, able to work in a fast-moving environment and prioritize work to achieve goals.
- Strong verbal and written communication skills, including technical writing.
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