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Amgen

Makes biotech medicines for serious illnesses

Manager Manufacturing Programs

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeThousand Oaks, CA, USAIn-person

About the Job

Requirements

  • A doctorate degree, or a master’s degree and 3 years of manufacturing and operations experience, or a bachelor’s degree and 5 years of manufacturing and operations experience, or an associate’s degree and 10 years of manufacturing and operations experience, or a high school diploma or GED and 12 years of manufacturing and operations experience.
  • Experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing the allocation of resources; managerial experience may run concurrently with the required technical experience.
  • Experience in GMP technical support roles, GMP operations, engineering, or process development is preferred.
  • Technical knowledge of drug substance processing and a broad understanding of related disciplinary areas are preferred.
  • Ability to communicate sophisticated technical information to internal and external colleagues at varying organizational levels through presentations and technical writing is preferred.
  • Ability to coach, mentor, and/or cross-train colleagues within a core technical area is preferred.
  • Ability to drive results through leadership of cross-functional teams is preferred.
  • Experience leading and managing projects and people is preferred.
  • Equipment and cleaning validation experience is preferred.
  • Understanding of stainless and single-use technologies is preferred.
  • Excellent writing skills and presentation experience, including presentations to leadership or auditors, are preferred.
  • Data analysis and/or data visualization skills are preferred.
  • Availability to work various shifts, including day, swing, overnight, weekends, holidays, 5x8-hour and 4x10-hour schedules, as instructed by the production schedule, to execute validation and project tasks with minimal disruption to operations, is preferred.
  • Ability to work in a clean room while wearing steel-toe shoes, full clean-room gowning, a hairnet, and gloves, and to follow GMP documents (SOPs) with strict adherence to safety and compliance, is preferred.

Responsibilities

  • Lead a team of manufacturing specialists who are subject matter experts in upstream manufacturing.
  • Demonstrate strategic problem-solving and champion continual improvement.
  • Manage sophisticated projects using project management skills.
  • Lead operational readiness for new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge along with project management skills.
  • Assess and advise on process impacts of changes.
  • Develop and own drug substance manufacturing processes and procedures; draft and revise GMP manufacturing documents, including SOPs and forms; and draft and develop user requirements for new technologies.
  • Write validation protocols and reports supporting cleaning validation, equipment commissioning, qualification, and change management.
  • Apply sophisticated process, scientific, operational, and compliance knowledge and analytical troubleshooting skills to support delivery of new technologies into the plant.
  • Handle quality records, such as CCMS, CAPA, and deviations.
  • Draft and revise GMP manufacturing documents, including SOPs and forms.
  • Support manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, the multiproduct facility operation program, CAPA, deviation investigations, and optimization and implementation of single-use technologies.
  • Identify appropriate corrective and preventive actions collaboratively and implement them.
  • Execute runs and experiments on the plant floor, work with large-scale equipment, and analyze and summarize data findings.
  • Define and document operational practices and ensure documentation accurately reflects operations performed.
  • Implement area improvements and commission equipment.
  • Design experiments, communicate findings, and participate in operations meetings.

Desired Qualifications

  • A degree in Engineering or Life Sciences is preferred.

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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