Collins McNicholas

Oversees the laboratory quality control testing of in-process, stability, and final drug products. Has technical responsibility for all bioanalytical aspects of QC testing.

Responsibilities:

  • Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Manages product testing to ensure efficient and compliant operations.
  • Reviews test reports.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
  • Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation
  • Track and monitor timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Special projects as assigned.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations

Skills, Education and Experience:

  • BS in chemistry, biology or related field with 7+ years’ relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years’ experience in a supervisory/leadership capacity.
  • Thorough understanding of bioanalytical techniques in a cGMP environment.

 

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