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Amgen

Makes biotech medicines for serious illnesses

Front Line Manufacturing Manager - Multiple Teams

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeHolly Springs, NC, USA$106.1k - $143.6k

About the Job

Requirements

  • A doctorate, 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, programs, or directing the allocation of resources.
  • Preferred: Bachelor's degree in Life Sciences or Engineering.
  • Preferred: Experience in biotechnology or pharmaceutical plant start-up.
  • Preferred: Basic understanding of upstream and/or downstream operations.
  • Preferred: Previous managerial experience directly managing people and/or experience leading teams, projects, programs, or directing the allocation of resources.
  • Preferred: Knowledge and experience within a cGMP or other highly regulated environment.
  • Preferred: 5 years of process experience in a cGMP manufacturing facility.
  • Preferred: 3+ years of experience in a production Area Lead, Specialist, or Manager role.
  • Preferred: Experience with performance management, including performance reviews.
  • Preferred: Conflict resolution, analytical problem solving, and project management skills.
  • Preferred: Thorough understanding of regulatory requirements.
  • Preferred: Excellent verbal and written technical communication skills.
  • Preferred: Computer skills with Microsoft, EBR/MES, Delta V, and electronic quality systems.

Responsibilities

  • Ensure a safe working environment for all.
  • Ensure Amgen policies are followed, including cGMP and Code of Federal Regulations compliance of assigned areas.
  • Evaluate and implement process improvements and optimizations, partnering with Quality, compliance, and Environmental, Health, Safety and Sustainability on change controls.
  • 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.
  • Be responsible for selection, training, evaluation, staff relations, and staff development.
  • Mentor and coach staff members 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.
  • Interact with management in optimizing organizational structure and responsibilities.
  • Ensure plant safety through auditing, evaluations, and cross-functional walks.
  • Demonstrate technical mastery of manufacturing processes.
  • Collaborate with cross-functional teams, including QA/QC, Facilities and Engineering, PPIC, Manufacturing, Process Development, and Regulatory, to complete production activities.
  • Develop, implement, and assess Corrective Action Preventive Actions 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.
  • Lead on-floor manufacturing operations and staff, championing safe and compliant production of GMP drug substance.
  • Participate in and model Lean culture and continuous improvement programs, translating them onto the manufacturing floor.
  • Assist in defining area objectives, identifying improvement opportunities, and leading change efforts to deliver short- and long-term operational goals.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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