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Analytical Project Manager

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Description

We are seeking a highly skilled Analytical Project Manager to join our QC Chemistry team. The successful candidate will be responsible for leading and participating in coordination and planning of analytical QC activities and support clinical and commercial manufacturing for our Customers worldwide.

Key Responsibilities:

  • Representing QC Chemistry in Customer project teams and internal AGC QC analytical teams
  • Liaising with cross-functional teams to ensure timely delivery of analytical method validations
  • Maintaining knowledge and overview of QC Project milestones and Batch release schedules
  • Responsible for coordination and overall timeliness of analytic method validations in collaboration with QC Subject Matter Experts
  • Specification owner including establishment and update of Specifications
  • Keeping overview and driving the in-house transfer of analytical methods from Analytical Development to QC
  • Relating building and communication inside and outside AGC Biologics
  • Writing and reviewing GMP documentation, including CR-cases, CAPAs, and deviations, CoAs, analytical set-ups
  • Upholding knowledge about commercial GMP production and/or production for late-stage clinical trials and production of biotechnological products and APIs
  • Participating in Regulatory inspections e.g. DMA, FDA and Customer audits (internal and external audits)
  • Advising Management on QC strategic matters

Requirements:

  • Master's degree in Chemistry, Biochemistry or other relevant area
  • 2-6 years' experience in analytical chemistry or a related field
  • Proven track record of working in cGMP settings according to European and US regulatory guidelines
  • Fluent in written and spoken English

About Us:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way.