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Senior Manager, Analytical Development Operations Lead

2 months ago

Morristown, New Jersey, United States Bayer Full time
About the Role

Bayer is seeking a highly experienced Senior Manager to lead our Analytical Development Operations, Compliance, and Clinical Supplies team. As a key member of our organization, you will be responsible for managing all analytical activities for clinical trials and consumer studies, including product release and stability study management.

Key Responsibilities
  • Lead and manage all clinical/consumer study AD activities, including generating specifications, managing testing, and preparing CoAs to support product shipment on time and meet all GMP requirements.
  • Lead GMP stability activities to support clinical/consumer studies, including creating stability plans, preparing stability protocols, managing stability sample pulls and testing, and coordinating with CSG on closing memos and managing final stability reports.
  • Manage 3rd party activities associated with clinical supplies, including requesting quotes, generating work orders, and arranging samples.
  • Support GMP raw material procurement and quality release activities.
  • Coordinate with project teams and stakeholders to determine project RM needs and support analytical activities such as critical review and approval of RM specs and CoAs.
  • Compile and organize all technical documentation related to raw materials and manage inventory.
  • Ensure timelines are met according to project requirements.
  • Support GMP Operations AD activities, including water quality reports, documentation reviews, and training.
  • Manage Change Controls, Deviations, CAPAs, and Quality Events in CS/RM/Metrology related objectives.
  • Draft and review SOPs and OIs for Analytical Development.
Requirements
  • Bachelor's Degree in Science or international equivalent with 8 or more years of proven experience, or Master's degree in Science or international equivalent with 6 or more years of proven experience.
  • High level of experience in clinical/consumer study analytical support and raw materials.
  • Expert knowledge in clinical/consumer product release requirements and concurrent stability management, and RM quality management.
  • Excellent oral and written communication skills, with an emphasis on clear and concise communication.
  • Excellent organization skills, multiple task management skills, and leadership skills to solve issues from vendors and internal requests.