(Sr.) Process Engineer, MSAT - Upstream
About The Position
Aura Biosciences is seeking a (Sr.) Process Engineer, MSAT – Upstream to support external drug substance manufacturing activities across clinical and commercial programs. This individual will report to the MSAT Lead, External Manufacturing and will play a critical role in tech transfer execution, engineering runs, and process performance oversight at CDMOs. This role will serve as the technical subject matter expert (SME) for upstream manufacturing operations including cell culture, viral production, harvest, and related unit operations. The candidate will act as Person-in-Plant (PIP) during GMP manufacturing campaigns and will ensure successful execution of engineering, PPQ, and commercial runs. This is a high-visibility role requiring strong cross-functional leadership, hands-on technical depth, and the ability to operate with urgency in a fast-paced environment.
Requirements
- B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related Life Sciences discipline.
- 4+ years (Process Engineer) or 6–8+ years (Senior Process Engineer) of relevant industry experience in biologics upstream manufacturing.
- Direct experience with cell culture, bioreactors, viral production systems, transient transfections or biologics fermentation platforms.
- Demonstrated experience working with external CDMO s and supporting GMP manufacturing.
- Strong knowledge of cGMP regulations and global regulatory expectations.
- Ability to interpret and trend process data to support root cause investigations.
- Strong written and verbal communication skills.
- Ability to travel ~20–30% as required for manufacturing oversight.
Nice To Haves
- Experience supporting engineering runs and/or PPQ campaigns preferred.
Responsibilities
- Lead and support tech transfer of cell culture and harvest processes to and within external partners, including gap assessments and readiness evaluations.
- Serve as upstream technical SME during engineering runs, GMP campaigns, and PPQ execution.
- Act as Person-in-Plant (PIP) at CDMOs providing front-line technical oversight.
- Drive resolution of manufacturing deviations, investigations, and change controls related to upstream unit operations.
- Collaborate cross-functionally with PD, AD, QA, QC, Supply Chain and Regulatory teams to ensure alignment through tech transfer and lifecycle management.
- Support development and execution of control strategies, risk assessments (FMEA), and continued process verification.
- Review and approve batch records, SOPs, and technical documentation.
- Analyze process performance data using statistical tools to monitor robustness and identify improvement opportunities.
- Support authoring and review of CMC sections related to upstream manufacturing for regulatory filings.
- Contribute to process scalability strategies and manufacturing readiness for commercial launch.
Benefits
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
