Manager, Contract Manufacturing
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Manager, Contract Manufacturing (Pharma): Oversee outsourced production at CMOs/TPMs for pharmaceutical drug substance, product, and packaging with an accent on on-time delivery, GMP compliance, and cost-effective operations. Focus on managing CMO performance, resolving technical issues, deviations, change controls, and cross-functional collaboration for uninterrupted supply.
Location: Hybrid role based out of Bridgewater, NJ office, option to work remotely most of the time with in-person collaboration; occasional domestic travel (~20%).
Salary: $124,000–161,000 Annual
Company
Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.
What you will do
- Oversee routine manufacturing at CMOs, resolve technical issues, support change controls and deviations.
- Manage commercial manufacturing documentation including MBRs, progress reports, PO/budget tracking, and CMC docs.
- Collaborate with Supply Chain, QA/QC, Regulatory CMC, Finance, Procurement, Project Planning, and CMOs for supply continuity.
- Ensure compliance with FDA, EMA, ICH guidelines, GMP, 21 CFR 212; manage deviations/CAPA.
- Coordinate supply chain for forecasting, procurement, inventory.
- Travel to vendor/manufacturing sites for support.
Requirements
- Bachelor’s degree + 5 years in pharmaceutical manufacturing, supply chain, or development.
- Experience with commercial CMO operations.
- Strong background in oral solid dosage manufacturing (spray drying, tableting, encapsulation).
- Knowledge of quality systems, validation, engineering design, statistical process control.
- Proven technical problem-solving; GMP, tech transfer, process scale-up, validation experience.
- Strong communication, interpersonal skills; ability to work independently in fast-paced environment.
Nice to have
- Advanced degree in Pharmacy, Chemistry, Engineering.
- Experience with inhaled powders, sterile manufacturing, blister packaging.
- Experience with Minitab.
Culture & Benefits
- Comprehensive medical, dental, vision, mental health support, wellbeing reimbursement, EAP.
- Generous PTO, fertility/family benefits, caregiver support, flexible schedules.
- 401(k) with match, equity awards, ESPP, company-paid life/disability insurance.
- Learning Institute: LinkedIn Learning, workshops, leadership programs, mentorship.
- Employee resource groups, volunteering, recognition programs.
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