VP, Manufacturing jobs in United States
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Loyal · 2 months ago

VP, Manufacturing

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. The Vice President of Manufacturing will lead all aspects of drug product manufacturing and packaging operations, ensuring late-stage manufacturing execution and product launch readiness.

BiotechnologyPetVeterinary
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Comp. & Benefits

Responsibilities

Lead all drug product manufacturing and packaging operations from late-stage development through commercial launch and ongoing commercial supply
Oversee process validation, PPQ, and commercial technology transfer to commercial manufacturing sites
Provide oversight and technical guidance for early-stage drug product process development, ensuring scalable, robust, and well-controlled processes
Drive CDMO selection, contracting, and governance, ensuring strong technical performance, quality, and supply reliability
Ensure manufacturing and packaging operations meet GMP compliance, process robustness, and global regulatory expectations
Author and review manufacturing-related CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and container–closure documentation
Lead technical interactions with regulatory authorities, including preparing briefing materials, responding to inquiries, and representing manufacturing during regulatory meetings
Support preparation and readiness for pre-approval inspections (PAIs), including technical documentation, training, and site responses
Partner with Quality to support technical investigations, root-cause analyses, and CAPA development
Contribute to process lifecycle management, including post-approval changes, continued process verification (CPV), and ongoing optimization
Partner with Supply Chain on launch readiness, production planning, technical supply risk assessment, and commercial supply continuity
Build, mentor, and lead a high-performing team supporting manufacturing, packaging, and technical operations

Qualification

PhD in Chemical EngineeringSmall molecule manufacturingGMP complianceRegulatory submissionsProcess validationCommercial manufacturing oversightTechnical investigationsCAPA developmentCross-functional leadershipCollaboration skills

Required

PhD in Chemical Engineering or a closely related discipline preferred; MS/BS candidates with extensive relevant experience will also be considered
15+ years of experience in pharmaceutical/biopharmaceutical manufacturing covering the full product lifecycle — early development, late-stage development, product launch, and commercial manufacturing
Experience in late-stage manufacturing, product launch, and commercial manufacturing oversight is a must
Experience building and scaling commercial manufacturing and packaging capabilities is a must
Experience supporting or overseeing early-stage drug product process development
Proven expertise in small molecule, oral solid dosage manufacturing, including tech transfer, PPQ, and process validation
Strong experience overseeing packaging operations, including packaging readiness and validation
Demonstrated ability to author manufacturing-related regulatory submission sections and respond to agency queries
Experience participating in or preparing for regulatory inspections, including PAIs
Strong understanding of GMP regulations and global manufacturing expectations (FDA, EMA, ICH)
Experience leading technical investigations, root-cause analyses, and CAPA development
Demonstrated success establishing governance with CDMOs, including technical and quality oversight
Effective cross-functional leader with strong communication and collaboration skills
Strategic, hands-on leader who thrives in a fast-paced, mission-driven biotech environment
Experience with lifecycle management, continued process verification, and post-launch operations

Preferred

Experience with veterinary or animal health manufacturing
Passion for Loyal's mission to bring science-driven longevity therapeutics to dogs — and ultimately humans

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
Bain Capital VenturesBridge BankKhosla Ventures
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