Upstream Bioprocess Development Lead

Rentschler Biopharma; Milford (MA); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

401K plan

Discretionary bonus program

Job summary

Rentschler Biopharma is seeking an experienced professional to lead downstream/upstream process development at our Milford, MA site. The role focuses on developing clinical and commercial bioprocesses, scaling experiments, and collaborating with MSAT to ensure robust processes.

The candidate should have extensive experience in bioreactor operation, DoE, and regulatory dossier preparation, with strong cross-functional communication skills and a track record of delivering complex projects on time.

Qualifications

• Experience leading bioprocess development and manufacturing projects.
• Strong collaboration with MSAT and other departments.
• Ability to prepare CMC dossiers and regulatory submissions.

Responsibilities

• Develop clinical and commercial upstream processes including harvest.
• Design experiments to optimize and scale processes.
• Lead, train, and mentor junior lab staff.
• Collaborate with MSAT on change controls and CAPAs.
• Interface with clients and prepare data for presentations.
• Transfer programs to manufacturing.

Skills

Bioreactor operation

Scale-up/scale-down principles

DoE (Design of Experiments)

CMC dossier knowledge

Statistical data analysis

Interdepartmental collaboration

Microsoft Office

Education

PhD with 5+ years

Master’s degree with 7+ years

Bachelor’s degree with 10+ years

Tools

Ambr

Single-use vessels

Process characterization tools

Job description

Rentschler Biopharma is seeking an experienced professional to lead downstream/upstream process development at our Milford, MA site. The role focuses on developing clinical and commercial bioprocesses, scaling experiments, and collaborating with MSAT to ensure robust processes.

The candidate should have extensive experience in bioreactor operation, DoE, and regulatory dossier preparation, with strong cross-functional communication skills and a track record of delivering complex projects on time.