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Merck Sharp & Dohme Farmaceutica3 weeks ago

Principal Scientist, Upstream Development

$173,200–$272,600 year

On-site · Rahway, New Jersey, United States

Type
Full Time
Level
Senior Level
Education
Doctorate Or Professional Degree
Company size
Unknown

Job Summary

Lead biologics upstream process development for first-in-human and commercial processes, providing technical direction for process development, characterization, and regulatory filings to ensure a smooth path to PPQ and BLAs. Develop strategies for upstream process technology and foster collaborations to adopt new technologies. Collaborate with academia, industry partners, and vendors to drive development and innovation. Maintain awareness of external patents and literature; actively publish and pursue patenting strategies. Supervise, coach, and educate junior scientists and drive career development; work in a matrixed team with internal and external partners. Qualifications include Ph.D. with 8+ years (or equivalent), strong CHO fed-batch know-how, cell culture bioreactors, CFD, DOE, and data-science-enabled process optimization. Preferred experience in early/late-stage development, technology transfer, high-throughput systems, and advanced analytics for process monitoring.

Required Qualifications

  • Ph.D. in Chemical Engineering, Bioengineering, Biochemistry or related field with 8+ years of industry experience; or Master’s with 10+ years; or Bachelor's with 14+ years; Proven upstream process development experience; CHO fed-batch expertise; scale-up/tech transfer experience; strong publication/presentation record; ability to lead cross-functional teams; strong data science and CFD experience
  • Experience in regulatory filings (PPQ, BLAs) and interface with regulatory processes
  • Experience mentoring junior scientists and leading projects
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$173k – $273k / yr

Principal Scientist, Upstream Development · Merck Sharp & Dohme Farmaceutica

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