Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift

Amgen • Holly Springs, NC

3d • $106,148 - $143,612

About The Position

Amgen is hiring a front-line manufacturing manager for its upstream bulk drug substance operations at the FleX Batch facility. The facility combines disposable technologies with traditional stainless-steel equipment and incorporates industry 4.0 capabilities and sustainability innovations. The manager leads experienced manufacturing associates producing GMP drug substance and champions safe, compliant operations through a structured on-floor presence. The role also supports Lean culture and continuous improvement, translating initiatives into manufacturing-floor practice.

With minimal direction, the manager leads floor operations and staff, including supervising, coaching, hiring, and developing employees. The manager helps define area objectives, identify improvement opportunities, lead change efforts, direct the team, and deliver short- and long-term operational goals. The stated schedule is a 2-2-3, 12-hour night-shift rotation from 5:45 PM to 6:15 AM.

Requirements

• Previous managerial experience directly managing people and/or experience leading teams, projects, or programs, or directing the allocation of resources.
• One of the following education and experience combinations: doctorate degree; master’s degree and 3 years of manufacturing and/or operations experience; bachelor’s degree and 5 years of manufacturing and/or operations experience; associate degree and 10 years of manufacturing and/or operations experience; or high school diploma/GED and 12 years of manufacturing and/or operations experience.

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.
• Previous managerial experience directly managing people and/or experience leading teams, projects, or programs, or directing the allocation of resources.
• Knowledge and experience in a cGMP or other highly regulated environment.
• Five years of process experience in a cGMP manufacturing facility.
• Three 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.
• Excellent computer skills, including Microsoft, EBR/MES, Delta V, and electronic quality systems.

Responsibilities

• Ensure a safe working environment and compliance with Amgen policies, cGMP, and CFR requirements in assigned areas.
• Evaluate and implement process improvements and optimizations, partnering with Quality, compliance, and EHSS on change controls.
• Interact with regulatory agencies as needed.
• Ensure proper gowning and aseptic techniques are followed.
• Engage staff, build relationships of trust and respect, and drive team performance and continuous improvement.
• Oversee staff selection, training, evaluation, staff relations, and development.
• Mentor and coach staff to live by Amgen Values.
• Develop and implement training plans and programs to ensure staff are prepared and compliant.
• 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.
• Collaborate with cross-functional teams to complete production activities.
• Develop, implement, and assess CAPAs and solutions to complex problems.
• Elevate and resolve problems during daily operations.
• Oversee setup, execution, and completion of critical manufacturing processes and tasks.
• Interact with management in planning, developing, and maintaining the budget.
• Assist in developing and maintaining department goals.
• Carry out other assigned functional responsibilities.

Benefits

• Full support and career-development resources to expand skills, improve expertise, and support career growth.
• A diverse and inclusive community of belonging where teammates are empowered to contribute ideas and take action.
• A Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed