MSAT Senior Scientist, Upstream

#2692 MSAT Senior Scientist, Upstream

Our client is looking to hire a Senior Scientist, Upstream MSAT. This role will report to the Lead Scientist, MSAT and serves as the technical lead for complex upstream technology transfer activities supporting viral vector pilot and GMP manufacturing campaigns. This role independently leads multiple client programs, provides technical mentorship to junior scientists, drives process robustness and continuous improvement initiatives, and serves as the primary upstream subject matter expert during GMP manufacturing. The Senior Scientist collaborates closely with Process Development, Manufacturing, Engineering, Quality, and clients to ensure successful implementation of clinical and commercial manufacturing processes.

Responsibilities:

• Lead multiple upstream technology transfer programs from process handoff through GMP execution.
• Serve as the primary upstream technical subject matter expert for internal and client-facing
• meetings.
• Develop and review technology transfer plans, process risk assessments, fit-to-plant assessments, sample plans, process flow diagrams, and bills of material.
• Lead authoring and review of GMP protocols, technical reports, process summaries, investigations, CAPAs, and change controls.
• Provide technical leadership during GMP manufacturing campaigns, including on-floor support and troubleshooting.
• Lead complex process investigations using data-driven root cause analysis.
• Mentor Scientist I and Scientist II personnel and provide technical coaching.
• Support development of process control strategies and continued process verification activities.
• Drive standardization and continuous improvement of upstream MSAT processes and
• documentation.
• Partner with Manufacturing, Engineering, QA, QC, Validation, Supply Chain, and Process
• Development to ensure successful campaign execution.
• Support resource planning and act as delegate for the Lead Scientist when appropriate.
• Provide technical support for process-related issues or investigations.
• Lead standardization efforts for Upstream tech transfer activities

Experience and Qualifications:

• BS (7 years experience), MS (3 years experience), or PhD (1-2 years experience) in Chemical Engineering, Biology, or similar life sciences degree with experience in Upstream technologies and demonstrated laboratory proficiency.
• Demonstrated experience supporting viral vector GMP manufacturing and technology transfer.
• Extensive experience with single-use bioreactors, adherent and suspension cell culture, seed train scale-up, media preparation, and upstream process troubleshooting.
• Advanced hands-on experience with common upstream pilot equipment and operations (i.e Single Use Bioreactors, adherent and suspension vector processes) and ability to train junior staff.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Demonstrated ability to maintain detailed execution records and perform data analysis.