About the job

We are looking for an Associate 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 and gene therapy products. This is an opportunity to work with curious minds in an inclusive culture, where you'll be working alongside PD Scientists and other core teams in supporting process and technology improvements, contributing to process understanding and characterization, and providing manufacturing support and technology transfer in a cGMP environment.

Position title

Associate Scientist

Role:

The role will be responsible for supporting PD Scientists in tech transfer activities and executing manufacturing processes for cell and gene therapy programs. This role will contribute in tech transfers driven by PD Scientists, support implementation in our in-house GMP manufacturing facility, and be a hands-on operator for the manufacturing campaign. This role requires support and 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:

· Assists and executes laboratory- based activities in supporting the tech transfer of new equipment and processing steps into GMP manufacturing.

· Supports PD Scientists and executes at-scale end-to-end runs in the PD labs to demonstrate process manufacturability and generate materials to support clinical trials.

· Assists in technology transfer to internal manufacturing facility by collaborating with cross-functional teams, e.g., SC, MFG, QA, QC.

· Support drafting of SOPs and MFG batch records.

· Manage and maintain the routine operation of the process equipment.

Qualifications:

· BS degree OR MS degree in Pharmaceutical Sciences, Biomedical Engineering, Biology or related field with one to two (1-2) year(s) of academia or industry experience.

· Hands-on experience in supporting cell and gene therapy process development.

· Hands-on experience with automation equipment used for cell and gene therapy manufacturing: Prodigy, LOVO, Sepax, bioreactors etc are a plus.

· Proficiency in laboratory skill sets including aseptic handling and cell culture techniques are required.

· Experience in assisting technical development of cell and gene therapies ranging from early to late-stage development.

· Knowledge of cGMP manufacturing, regulations and practical experience in GMP operations are a plus.

· Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.

· A team player, 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.