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Senior Principal Scientist, Technical Operations

Location

United States

Posted

123 days ago

Salary

$175K - $230K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglish

Job Description

Senior Principal Scientist, Technical Operations

Loyal

• Own and lead the end-to-end drug product development strategy, including pre-formulation, formulation development, scale-up, and clinical manufacturing. • Serve as the technical lead for all drug product activities with CDMOs, including selection, oversight and troubleshooting • Provide strategic guidance on raw material sourcing, manufacturability, product quality risk assessments, and lifecycle management considerations. • Identify and proactively mitigate technical, regulatory, and supply risks; develop contingency strategies to ensure program continuity. • Author, review, and approve drug product CMC sections for regulatory submissions (IND/CTA and amendments), and represent Drug Product CMC in regulatory agency interactions. • Lead technical due diligence efforts, including CDMO evaluation, proposal review, data integrity assessments, and master batch record approval. • Establish and implement robust experimental strategies, including design of experiments (DoE), to optimize formulation and process development. • Mentor and provide scientific leadership to internal team members and consultants; elevate organizational capabilities in drug product development. • Lead process readiness activities for Pre-Approval Inspections (PAIs), ensuring manufacturing processes, documentation, validation packages, and technology transfer records are inspection-ready and aligned with regulatory expectations

Job Requirements

  • Ph.D. in Material Science, Chemical Engineering, or related physical science.
  • 10+ years of industry experience in preferably small molecule oral solid dosage formulation development, with demonstrated ownership of drug product strategy through clinical stage development.
  • Proven experience leading development of novel molecular entities.
  • Significant experience selecting, managing, and overseeing CDMOs for formulation development, technical transfer, scale-up, and GMP manufacturing.
  • Deep expertise in preferably small molecule oral tablet formulation, process development, compaction fundamentals, and manufacturing science.
  • Demonstrated experience authoring and defending CMC regulatory submissions.
  • Significant hands-on experience designing and executing statistically sound development programs using DoE and data-driven decision frameworks.
  • Experience supporting technical diligence and external partnership evaluations.
  • Veterinary dosage form experience preferred but not required.
  • Demonstrated ability to operate effectively in a dynamic, fast-paced startup environment.

Benefits

  • Full-coverage health insurance — medical, dental and vision — for you and your dependents
  • $1,000 home office equipment stipend
  • $1,200/year learning budget for books, courses, etc.
  • $250/month wellness budget for gym, cleaners, spa, food, etc.
  • All 3-day weekends are turned into 4-day weekends 🎉
  • Unlimited vacation and paid holidays
  • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
  • Competitive salary
  • Company equity options grant for new hires

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