Manufacturing Operations Manager
2 days ago
Frontage Laboratories is seeking a highly skilled Manufacturing Operations Manager to lead our clinical trial material manufacturing operations. As a key member of our team, you will be responsible for overseeing all aspects of manufacturing, including staff supervision, facility and equipment qualification, technology transfer, scheduling, and project management.
Key Responsibilities:
- Manage the manufacturing and supply of clinical trial materials (CTM) for oral solid doses and sterile drug products.
- Supervise a team of manufacturing technologists, operators, and warehouse coordinators.
- Interface with product development teams for knowledge transfer and process development.
- Collaborate with cross-functional teams to ensure proper project execution.
- Develop and implement technically sound clinical manufacturing batch records, SOPs, protocols, and specifications.
- Manage quality control records, change controls, CAPAs, and other GMP-related documents.
- Partner with CMC project management for alignment on and prioritization within manufacturing timelines.
- Write, review, and approve SOPs, qualification protocols, and other GMP documentation.
- Develop and maintain strategic partnerships with technical and operational colleagues.
Requirements:
- Bachelor's degree in pharmaceuticals, engineering, or sciences.
- 8+ years of experience in the pharmaceutical industry, with 5+ years of people management experience.
- Strong experience in tech transfer, process development, facility and equipment validation/qualification, and pharmaceutical manufacturing.
- Experience with cGMP guidelines and regulations, including FDA, EMEA, and ISO regulations.
- Strong oral and written communication and interpersonal skills.
What We Offer:
Frontage Laboratories offers a competitive compensation and benefits package, including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. We are an equal opportunity employer and welcome applications from qualified candidates.
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