Scientist, Upstream Process Development

Responsibilities

• Develop scalable and robust upstream processes, including process characterization and technology transfer to clinical and commercial GMP manufacturing, meeting project deliverables.
• Use QbD principles to design and execute experiments related to development, optimization, scale down and scale up of mammalian cell culture unit operations, utilizing shake flasks, high‑throughput AM  systems, and bench‑scale to 200 L pilot‑scale bioreactors.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
• Apply advanced statistical techniques to design experiments related to process development and characterization.
• Author high‑quality documents including technical reports, SOPs, and experimental protocols.
• Serve as a Process Development representative and participate in cross‑functional meetings.
• Contribute to scale‑up activities and draft technical transfer documents such as process descriptions and flow diagrams.
• Review batch records and provide comments.
• Support manufacturing floor activities and process deviations, including effective CAPAs.
• Provide technical support (process/operational gap identification and troubleshooting) to MSAT and the manufacturing group.
• Compile and present data to client project teams and author reports.
• Contribute to overall operations of the process sciences laboratory and infrastructure improvements.
• Provide technical and strategic planning support to business development activities related to new client projects and initiatives.
• Train and/or lead Associate Scientists.

• Minimum of 5 years of related experience with a university degree, or 3 years with a master's degree, or 1 year with a PhD.
• Solid theoretical knowledge and hands‑on experience in cell culture process development, aseptic technique, and bioreactor operation.
• Desirable experience with cell banking, harvest unit operations, AM  operation, MODDE statistical tools, and ICH guidelines.
• Self‑motivated, accountable, inquisitive, with excellent organization and communication skills.
• Advanced proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Ability to work independently and as part of local/global teams.
• Excellent customer‑service skills and ability to meet client project deadlines.
• Flexibility in working hours to support laboratory and manufacturing floor activities, including compensated weekend and holiday hours per company policies.

• Laboratory environment with chemical reagents and genetically modified cells; normal office conditions with computer, phone, files.
• Personal protective equipment required as applicable.
• Fast pace; high demand for timely completion.

• Frequent lifting up to 10 lbs.
• Frequent standing/walking in lab environment for extended periods.
• Frequent sitting for extended periods to use computer.
• Wearing PPE as required.

Base Pay Range: $43/hr – $52/hr.

Rentschler Biopharma is an equal opportunity employer and encourages applicants of all backgrounds.