Sr. Manager of Manufacturing, Manufacturing Services
Listed on 2026-07-18
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Manufacturing / Production
Regulatory Compliance Specialist
Overview
Senior Manager of Manufacturing, Manufacturing Services ds the Manufacturing Services team to ensure safe, compliant, and efficient operations within Raw Material Weigh and other process support activities. Responsible for GMP support of manufacturing areas and equipment, ensuring compliance with cGMP, GDP, and other applicable regulations.
Key Responsibilities- Oversee and ensure all GMP support manufacturing activities are conducted in a compliant, agile, and cost‑effective manner.
- Ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP, and other applicable regulations and specifications.
- Lead investigations, corrective actions, and preventive actions associated with process deviations or non‑conformances.
- Identify, assess, and mitigate risks to ensure the safety, purity, quality, and effectiveness of manufactured products.
- Develop and lead a high‑performance team, building technical and leadership capabilities.
- Maintain controlled documents for the area of responsibility and alert senior management of significant risks.
- Plan and oversee GMP activities for assigned areas and support continuous improvement initiatives.
- Serve as subject‑matter expert during health authority inspections.
- Develop and implement departmental strategies aligned with the broader site strategy.
- Champion functional transformation and institutionalize best practices.
- Ensure effective decision‑making, communication, and alignment across the organization.
- Recruit, develop, and retain a diverse and inclusive manufacturing services organization.
- Plan, develop, and maintain the department budget while minimizing scrap waste.
- Allocate resources and manage external worker expenses.
- High school diploma / GED and 12 years of biologics and/or GMP manufacturing experience
- Associate’s degree and 10 years of biologics and/or GMP manufacturing experience
- Bachelor’s degree and 8 years of biologics GMP manufacturing experience
- Master’s degree and 6 years of biologics and/or GMP manufacturing experience
- Doctorate degree and 2 years of biologics and/or GMP manufacturing experience
- Minimum of 2 years of direct management experience leading people and/or teams
- Bachelor’s degree in Engineering, Science, or a related field (advanced degree preferred)
- 8+ years of experience in a GMP manufacturing environment with a strong understanding of cGMP regulations
- 5+ years of leadership experience with a record of developing and leading successful teams
- Strong problem‑solving skills and ability to manage complex projects and initiatives
- Excellent communication, interpersonal, and organizational skills
- Experience with budget management and financial planning
Comprehensive employee benefits package including retirement and savings plan, health, dental, vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models.
SalaryAnnual salary range: USD–USD (US only).
Equal Opportunity EmployerAmgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. Amgen will provide reasonable accommodation to individuals with disabilities.
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