Supervisor - DSM (Upstream) Leader

3 weeks ago

Holly Springs, Georgia, United States FUJIFILM Holdings America Corporation Full time
About This Role

This role leads a shift team and is responsible for manufacturing bulk drug substance in a 24/7 operational environment. The ideal candidate will have a high degree of knowledge and expertise of production equipment and manufacturing run cadence.

Key Responsibilities
  • Supports Factory Acceptance Testing (FAT) at the vendor site as required
  • Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
  • Performs other operational readiness tasks as required, such as document review/approval, team onboarding, and materials management
  • Supervises manufacturing associates on technical and operational topics, such as area unit operations and equipment
  • Administers company policies, such as travel & expense, time reporting, and time off that directly impact employees
Requirements

The ideal candidate will have:

  • A high degree of knowledge and expertise of production equipment and manufacturing run cadence
  • Understanding of manufacturing run cadence and order of shift activities
  • Expertise in cGMP, safety, and FDBN operational procedures
  • Strong cross-functional partnership with Quality, Process Sciences, Process Engineering, and others
  • Ability to create and maintain a collaborative and inclusive team
  • Ability to travel and have a valid passport
Education and Experience

The ideal candidate will have:

  • High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects
  • BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects
  • Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects
  • Military Experience of equivalence
Physical Requirements

The ideal candidate will be able to:

  • Work in an environment which may necessitate respiratory protection
  • Work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
  • Ability to discern audible cues
Working Environment

The ideal candidate will be able to:

  • Ability to ascend or descend ladders, scaffolding, ramps, etc.
  • Ability to stand for prolonged periods of time
  • Ability to sit for prolonged periods of time
  • Ability to conduct activities using repetitive motions that include wrist, hands, and/or fingers
  • Ability to conduct work that includes moving objects up to 33 lbs.
Equal Opportunity Employer

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

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