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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

About the Job

Requirements

  • A doctorate degree, or a master's degree and 3 years of manufacturing or operations experience, or a bachelor's degree and 5 years of manufacturing or operations experience, or an associate's degree and 10 years of manufacturing or operations experience, or a high school diploma or 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.
  • A bachelor's degree in Life Sciences or Engineering is preferred.
  • Demonstrated strong leadership skills and technical understanding of biotechnology production operations.
  • Experience in biotechnology or pharmaceutical plant start-up.
  • Understanding of downstream purification operations, including column chromatography, tangential flow filtration, viral filtration, and viral inactivation.
  • Previous knowledge and experience within a current good manufacturing practice environment.
  • Five or more years of process experience in a current good manufacturing practice 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.
  • Verbal and written technical communication skills.
  • Computer skills with Microsoft, electronic batch record/manufacturing execution systems, DeltaV, and electronic quality systems.

Responsibilities

  • Ensure a safe working environment.
  • Ensure Amgen policies are followed, including current good manufacturing practice and Code of Federal Regulations compliance in assigned areas.
  • Evaluate current operating procedures and recommend changes to management to optimize production.
  • Ensure corporate change control procedures are followed and Regulatory and Quality Assurance are notified before changes.
  • Interact with regulatory agencies as needed.
  • Ensure 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 follow Amgen Values.
  • Develop and implement training plans and programs to ensure staff are prepared and compliant.
  • Ensure adherence to the production schedule and maintenance activities.
  • Interact with management to optimize organizational structure and responsibilities.
  • Ensure plant safety through auditing, evaluations, and cross-functional walks.
  • Ensure gowning and aseptic technique training programs are maintained.
  • Demonstrate technical mastery of manufacturing processes.
  • Collaborate with cross-functional teams, including Quality Assurance/Quality Control, Facilities and Engineering, Production Planning and Inventory Control, Manufacturing, Process Development, and Regulatory, to complete production activities.
  • Develop, implement, and assess corrective and 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.
  • Define area objectives, identify improvement opportunities, and lead change efforts while directing the team and delivering short- and long-term operational goals.
  • Oversee teams conducting technical, on-the-floor operations in a biotechnology production operation and support staff development through coaching, hiring, and mentorship.
  • Champion a safe and compliant production environment through structured on-the-floor presence and embed Lean and continuous improvement principles on the manufacturing floor.

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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