Senior Scientist, Upstream MSAT
Onsite Requirement
100% onsite
Location
On-site, PA 19406
Position Id
2692
Recruiter Contact
SARAH
Job Description
The Senior Scientist, Upstream MSAT reports 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.Primary 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.
Education, 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.
• Technical leadership without direct people management.
• Ability to follow procedures with attention to detail and successfully troubleshoot.
• 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.
• Knowledge or experience with gene therapy manufacturing in the biotech industry is preferred.
• Strong communication skills (e.g., clear and concise) and a team player.
• Strong time and project management skills.
• Critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
• Ability to prioritize multiple programs in a fast-paced environment.
• Leads and takes ownership of the assigned projects.
• Able to understand and interpret data/information and its practical application.