Principal Scientist I, Biologics Drug Product Development

Added
24 minutes ago
Type
Full time
Salary
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regulatory filings process development scale-up cgmp cmc
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📋 Description

  • Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and
  • Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders
  • Support scale-up and technology transfer activities to internal and external manufacturing sites.
  • Lead the design and execution of biologics drug product formulation and process development
  • Initiate and/or support scientific initiatives to drive innovation, continuously enhance

🎯 Requirements

  • BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or
  • Proven ability to solve critical scientific problems.
  • Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic
  • Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration
  • Experience leading drug product development as the functional lead within cross-functional teams.
  • Preferred: Hands-on experience with authoring regulatory filings for biologics and sterile

🎁 Benefits

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick)
  • This job is eligible to participate in our short-term incentive programs.
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