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

Amgen•Holly Springs, NC

10d•$106,148 - $143,612•Onsite

About The Position

Amgen is seeking a Front Line Manufacturing Manager for their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for maximum flexibility and incorporates industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. The role is for the Downstream process on the Night Shift.

Requirements

Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

Bachelor’s degree in Life Sciences or Engineering
Demonstrated strong leadership skills and technical understanding of biotechnology production operations
Experience in biotechnology or pharmaceutical plant start up
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Previous knowledge and experience within a cGMP environment
5+ years process experience in a cGMP manufacturing facility
3+ years of experience in a production Area Lead, Specialist or Manager role
Strong leadership and teambuilding skills (coaching, mentoring, 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 communication (technical) skills
Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems

Responsibilities

Oversee teams of manufacturing associates responsible for the manufacture of GMP drug substances.
Champion a safe and compliant production environment through structured on-the-floor presence.
Imbed Lean and continuous improvement principles onto the manufacturing floor as an active participant and role model.
Oversee teams in technical, on-the-floor operations in a biotechnology production operation.
Support the development of staff through coaching, hiring, and mentorship.
Assist in defining area objectives, identifying improvement opportunities, and leading change efforts.
Effectively direct their team and deliver short- and long-term Amgen Operational goals.
Ensure safe working environment.
Ensure Amgen policies are followed, including cGMP and CFR compliance of assigned areas.
Evaluate current operating procedures and recommend changes to management to optimize production.
Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to changes.
Interact with regulatory agencies as needed.
Assure proper gowning and aseptic techniques are followed.
Engage staff and build relationships of trust and respect while driving team performance and continuous improvement.
Recruit, train, evaluate, coach, and develop staff.
Mentor and coach staff members to live by the Amgen Values.
Develop and implement training plans and programs to ensure staff are prepared and compliant.
Ensure adherence to production schedule and maintenance activities.
Interact with management in optimizing organizational structure and responsibilities.
Ensure plant safety through auditing, evaluations, and cross-functional walks.
Ensure gowning and aseptic techniques training programs are maintained.
Demonstrate technical mastery of manufacturing processes.
Collaborate with cross-functional teams (i.e., QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities.
Develop, implement, and assess CAPAs and solutions to complex problems.
Responsible for elevating and resolving problems during daily operations.
Oversee set up, execution, and completion of critical manufacturing processes/tasks.
Interact with management in planning, developing, and maintaining budget.
Assist in developing and maintaining department goals.