VP, Manufacturing
Loyal
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $270,000 - $320,000 per year
Job Level
Lead
About the role
- 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.
Requirements
- 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.
- 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.
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
process validationPPQcommercial technology transferdrug product process developmentsmall molecule manufacturingoral solid dosage manufacturingregulatory submissionsGMP complianceCAPA developmentlifecycle management
Soft skills
leadershipcommunicationcollaborationmentoringstrategic thinkingcross-functional leadershipproblem-solvingtechnical guidanceoversightteam building
Certifications
PhD in Chemical EngineeringMS in Chemical EngineeringBS in Chemical Engineering