Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift
About The Position
The Manager Manufacturing (Upstream) is the on-shift front-line manager for manufacturing at Amgen’s FleX Batch drug substance facility. The role leads experienced manufacturing associates who manufacture GMP drug substance and champions a safe, compliant production environment through structured on-floor presence. The manager leads floor operations with minimal direction, demonstrates technical understanding of biotechnology production, and serves as a role model for Lean culture and continuous improvement. This position supervises, coaches, hires, and develops floor staff; helps define area objectives and improvement opportunities; and leads change efforts to deliver short- and long-term operational goals. The schedule is a night shift on a 2-2-3, 12-hour rotation, from 5:45 PM to 6:15 AM.
Requirements
- Doctorate degree; or a Master’s degree and 3 years of manufacturing and/or operations experience; or a Bachelor’s degree and 5 years of manufacturing and/or operations experience; or an Associate degree and 10 years of manufacturing and/or operations experience; or a high school diploma/GED and 12 years of manufacturing and/or operations experience.
- Previous managerial experience directly managing people and/or experience leading teams, projects, or programs, or directing the allocation of resources.
Nice To Haves
- Bachelor’s degree in Life Sciences or Engineering.
- Experience in biotechnology or pharmaceutical plant start-up.
- Basic understanding of upstream and/or downstream operations.
- Knowledge and experience in a cGMP or other highly regulated environment.
- 5 years of process experience in a cGMP manufacturing facility.
- 3 or more years of experience in a production Area Lead, Specialist, or Manager role.
- Strong leadership and team-building skills, including coaching, mentoring, and counseling.
- Experience with performance management, including performance reviews.
- Conflict resolution, analytical problem-solving, and project-management skills.
- Thorough understanding of regulatory requirements.
- Excellent verbal and written technical communication skills.
- Strong computer skills, including Microsoft applications, EBR/MES, Delta V, and electronic quality systems.
Responsibilities
- Ensure a safe working environment and compliance with Amgen policies, cGMP, and applicable CFR requirements.
- Evaluate and implement process improvements and optimizations in partnership with Quality, Compliance, and EHSS, including change controls.
- Interact with regulatory agencies as needed and ensure proper gowning and aseptic techniques.
- Engage staff, build relationships of trust and respect, and drive team performance and continuous improvement.
- Select, train, evaluate, and develop staff; mentor and coach employees to live by Amgen Values.
- Develop and implement training plans and programs to ensure staff readiness and compliance.
- Ensure adherence to production schedules and maintenance activities.
- Work with management to optimize organizational structure and responsibilities.
- Promote plant safety through audits, evaluations, and cross-functional walks.
- Demonstrate technical mastery of manufacturing processes and collaborate with cross-functional teams to complete production activities.
- Develop, implement, and assess CAPAs and solutions to complex problems.
- Escalate and resolve problems during daily operations.
- Oversee setup, execution, and completion of critical manufacturing processes and tasks.
- Participate with management in planning, developing, and maintaining the budget.
- Assist in developing and maintaining department goals.
- Carry out other functional responsibilities as assigned.
Benefits
- Full support and career-development resources to expand skills, expertise, and career potential.
- A diverse and inclusive community of belonging where teammates are empowered to contribute ideas and act.
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
