Senior Principal Scientist, Technical Operations jobs in United States
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Loyal · 3 hours ago

Senior Principal Scientist, Technical Operations

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, aiming to help them live longer, healthier lives. The Senior Principal Scientist will serve as the technical authority and strategic leader for drug product development, overseeing formulation and manufacturing strategy from preclinical development through early clinical stages.

BiotechnologyPetVeterinary
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Comp. & Benefits

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

Qualification

Drug product developmentFormulation developmentCMC regulatory submissionsStatistical design of experimentsCDMO managementSmall molecule formulationTechnical risk mitigationMentoringLeadershipCollaboration

Required

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

Preferred

Veterinary dosage form experience preferred but not required

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

Company

Loyal

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Loyal is a biotechnology company developing medicines to extend dogs lifespan and maintain their quality of life.

Funding

Current Stage
Growth Stage
Total Funding
$137.07M
Key Investors
Collaborative Fund,Valor Equity PartnersBain Capital VenturesBridge Bank
2025-02-26Series B· $22M
2024-03-21Series B· $45M
2024-03-21Debt Financing· $12M

Leadership Team

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Celine Halioua
Founder & CEO
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Sudharika Gogna
Chief Operating Officer
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Company data provided by crunchbase