Scientist, Upstream Process Development (3-6 Month Contract)

Rentschler Biopharma • Milford, MA

2d • Onsite

About The Position

This Scientist position is in the Upstream Process Development group within the Process Sciences Team. The person in this role designs and executes cell culture processes development including technology transfer activities both from the client(s) and internally to GMP manufacturing facility.

Requirements

• A university degree and 5+ years of related experience
• A Master’s degree and 3+ years
• A PhD and 1+ years(s) of experience
• Solid theoretical knowledge and hands-on experience cell culture process development, including aseptic technique and bioreactor operation
• Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)
• Demonstrates ability to work both independently and as a member of local / global teams
• Excellent customer service skills and ability to meet client project deadlines

Nice To Haves

• Cell Banking, Harvest Unit Operations, AMBR operation, MODDE statistical tools, ICH guidelines

Responsibilities

• Development of scale-able and robust upstream processes including process characterization, and/or technology transfer to clinical and commercial GMP manufacturing while meeting the project deliverables
• Use QbD principles to design and execute experiments related to development, optimization, and scale down/ scale-up of all mammalian cell culture unit operations utilizing shake flasks, high-throughput AMBR systems, and bench scale to 200L pilot scale bioreactors
• Design and execute experiments related to development, optimization, and scale down/ scale-up of all mammalian cell culture unit operations
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
• Ability to work in a team environment and drive the success of the team
• 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 related documents (e.g. process description, process flow diagram)
• Review batch records and provide comments
• Support MFG floor activities and process deviations including effective CAPAs
• Provide technical support (e.g. process/operational gap identification and troubleshooting) to MSAT and the manufacturing group
• Compile and present data at client project teams and author reports
• Contribute to the overall operations of process sciences lab and infrastructure improvements
• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
• Train and/or lead Associate Scientists

Benefits

• annual discretionary bonus program
• medical insurance
• generous 401K program
• a host of other benefits to aligned to support our employees’ personal and professional wellness

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level