Senior Principal Scientist, Technical Operations

Loyal

7d • $175,000 - $230,000

About The Position

The Senior Principal Scientist will serve as the technical authority and strategic leader for drug product development. This role is responsible for defining and driving formulation and manufacturing strategy from preclinical development through early clinical stages, ensuring technical excellence, regulatory alignment, and execution across external partners.
This individual will act as the internal subject matter expert for drug product CMC, influencing cross-functional decision-making and shaping long-term development strategy.
You will be reporting to our VP of manufacturing.

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.
• Demonstrated ability to operate effectively in a dynamic, fast-paced startup environment.

Nice To Haves

• Veterinary dosage form experience preferred but not required.

Responsibilities

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree