Senior Upstream Process Development Lead (Scale-Up)

Rentschler Biopharma Inc.

Milford (CT)

On-site

USD 120,000 - 145,000

Full time

7 days ago

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Job summary

Rentschler Biopharma Inc. is seeking a senior process expert to advance upstream development at our Milford site. You will design experiments, apply QbD for PPQ campaigns, and collaborate with MSAT and manufacturing to ensure smooth tech transfers.

Strong bioreactor and DoE expertise are essential. Ideal candidates bring 10+ years in biotech process development, solid data-analysis skills, and a track record of cross-functional leadership, enabling delivery of high-quality documentation for

Qualifications

University degree with 10+ years related experience or graduate degrees with commensurate experience.
Expertise in bioreactor operation, scale-up/scale-down, DoE, and CMC dossier sections.
Strong communication, planning and cross-functional collaboration skills.
Ability to work independently and in global teams with client interfaces.

Responsibilities

Develop clinical and commercial upstream processes including harvest.
Design experiments to optimize, characterize, or scale processes.
Apply QbD principles for PPQ campaigns and CAPA-based improvements.
Collaborate with MSAT, other departments, and clients; prepare technical data and reports.
Transfer programs to manufacturing and author necessary documents.