3 дня назад
Manager, Contract Manufacturing (Pharmaceutical Manufacturing)
124 000 - 161 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager, Contract Manufacturing (Pharmaceutical Manufacturing): Developing, optimizing, scaling up, and executing pharmaceutical manufacturing operations with an accent on contract manufacturing oversight, spray drying, process validation, and GMP compliance. Focus on supervising global CMO production, transferring processes from pilot to commercial scale, troubleshooting equipment, and preparing processes for registration and commercial readiness.
Location: Fully remote; can be performed from anywhere. Occasional team travel and frequent global travel of up to 50% to CDMO sites in the US and EU are expected.
Salary: $124,000–$161,000 annual.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Provide real-time, on-site oversight of contract manufacturing organizations during routine manufacturing, technology transfer, equipment installation, optimization, and process validation.
- Design, develop, optimize, and scale pharmaceutical API and formulation manufacturing processes, with an emphasis on spray drying and low-fill-weight powder encapsulation.
- Transfer spray drying and other drug product processes from pilot to commercial scale at primary and secondary CMOs.
- Troubleshoot drug product process equipment and ensure efficient, GMP-compliant operations.
- Develop and execute IQ, OQ, and PQ validation protocols and prepare processes for registration, validation, and commercial readiness.
- Analyze process data, identify critical process parameters, prepare technical reports, and collaborate with R&D, manufacturing, quality, regulatory CMC, and formulation teams.
Requirements
- Bachelor’s degree and at least five years of experience in pharmaceutical process engineering or manufacturing.
- Experience with late-phase clinical and commercial CMO operations.
- Strong pharmaceutical spray-drying experience, plus experience with GMP manufacturing, technology transfer, process scale-up, and validation.
- Working knowledge of quality systems, validation principles, engineering design, statistical process control, and DOE.
- Ability to conduct root-cause analysis, solve problems, and document compliant investigations and outcomes.
- Ability to work independently in a remote environment and collaborate effectively in a fast-paced, multidisciplinary setting.
Nice to have
- Experience with capsule filling and blister primary packaging.
Culture & Benefits
- Fully remote work with connection to the community and purposeful in-person collaboration.
- Medical, dental, vision, and mental health support, plus annual wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, service programs, and volunteer opportunities.
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