MSAT Principal Scientific Associate (Contract) 28160
About The Position
The MSAT Lab Sciences Principal Scientific Associate will be part of a team responsible for supporting process improvement studies, taking part in laboratory investigations, as well as characterization of cell product for ongoing and future projects. Reporting to the MSAT Lab Sciences Manager or designee. The ideal candidate will have experience in a cell and gene therapy lab, working with CRISPER-Cas9, Miltenyi & Cytivia products, aseptic techniques, lab notebook and cell culture. Key Duties & Responsibilities Supports life cycle management of approved cell and gene therapy projects conducting process improvement studies Participates in the development of protocols and technologies in support of post commercial improvement initiatives. Applies DOE/QBD principals to process development and characterization, establishing process parameters, and contributing to CMC sections of regulatory filings May contribute to parts of technology transfer to manufacturing and CMOs and provides informal guidance and training for GMP production, as required Makes significant contributions to the design, planning, execution, and documentation of experiments and data analyses in support of process improvement with minimal supervision Drafts and reviews study protocol and reports while ensuring data integrity Prepares and presents data summaries to the team and department Work with Scientist and Engineers to address and solve complex problems through in-depth troubleshooting Works within departmental teams, develops cross-departmental collaborations, supports deliverables, and participates in or leads team discussion on experimental design, planning, and issue resolution Participates in weekend work rotation with the broader team
Requirements
- Bachelor's or Master’s degree in a relevant scientific/engineering field is required
- Excellent communication skills to exchange technical/scientific information to a wide variety of audiences
- Ability to build collaborative relationships and work effectively as a member of a multidisciplinary team
- Direct industry experience developing early and/or late phase clinical/commercial cell or gene therapies
- Excellent organizational skills and high attention to detail
Nice To Haves
- Prior experience with human sourced material preferred.
Responsibilities
- Supports life cycle management of approved cell and gene therapy projects conducting process improvement studies
- Participates in the development of protocols and technologies in support of post commercial improvement initiatives.
- Applies DOE/QBD principals to process development and characterization, establishing process parameters, and contributing to CMC sections of regulatory filings
- May contribute to parts of technology transfer to manufacturing and CMOs and provides informal guidance and training for GMP production, as required
- Makes significant contributions to the design, planning, execution, and documentation of experiments and data analyses in support of process improvement with minimal supervision
- Drafts and reviews study protocol and reports while ensuring data integrity
- Prepares and presents data summaries to the team and department
- Work with Scientist and Engineers to address and solve complex problems through in-depth troubleshooting
- Works within departmental teams, develops cross-departmental collaborations, supports deliverables, and participates in or leads team discussion on experimental design, planning, and issue resolution
- Participates in weekend work rotation with the broader team
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What This Job Offers
Job Type
Full-time
Career Level
Principal
