Senior Principal Scientist, Technical Operations
Loyal
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $175,000 - $230,000 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug product developmentformulation developmentscale-upclinical manufacturingraw material sourcingproduct quality risk assessmentsdesign of experiments (DoE)CMC regulatory submissionsGMP manufacturingdata-driven decision frameworks
Soft Skills
leadershipmentoringstrategic guidanceproblem-solvingcommunicationorganizational capabilitiesrisk mitigationtechnical oversightcollaborationadaptability
Certifications
Ph.D. in Material SciencePh.D. in Chemical Engineering