Scientist Biostatistics, CPV-MSAT

Shift Available:
- Monday–Friday, Hybrid Day Shift, 8:00 a.m.–4:30 p.m.

Responsibilities:
- Assist in maintaining the site SPC program and support manufacturing performance trending/reporting.
- Support multivariate analysis (MVA) modeling to improve process understanding/robustness.
- Collaborate cross-functionally; support investigations with relevant data/analysis.
- Support CPV and APQR by completing assigned tasks accurately and on schedule.
- Develop/maintain process monitoring analytics under senior guidance.
- Investigate/proactively address drift in product performance.
- Represent MSAT CPV team in cross-functional forums as needed; prepare/review CPV/APQR site documents.
- Support safe, compliant cGMP operations and inspection readiness.
- Interact with Operational Excellence, PMO, site MSAT, Quality, Process Support/Engineering, Manufacturing Ops, and Supply Chain.
- Stay current via training/best-practice forums; support Opex opportunities via data-driven evaluations.

Knowledge & Skills (required/preferred):
- Statistical methods/tools for data-driven decisions in manufacturing.
- Proficiency in statistical software/languages (R, JMP, Minitab, SAS; JMP preferred).
- Detail oriented; strong time management.
- Verbal/written communication; cross-functional teamwork.
- cGMP and biopharmaceutical/cell therapy regulatory knowledge.
- Familiarity with clean room/facility operations and manufacturing workflows.
- Plus: single-use/closed systems/cold chain-cryogenic; Operational Excellence/Lean.

Minimum Requirements:
- Bachelor’s required (science/engineering preferred); graduate degree preferred.
- 4+ years biopharmaceutical/related manufacturing support.
- 1+ year direct CPV and/or APQR reporting exposure (or relevant quality monitoring/trending).
- 1+ year cell therapy/biologics/vaccine manufacturing/support exposure.

Working conditions:
- Adhere to BMS policies/procedures; gown to access classified manufacturing areas as needed.