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Analytical Development Manager

1 month ago


Cork, Cork, Ireland myGwork - LGBTQ+ Business Community Full time

1 day ago Be among the first 25 applicants

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This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Job Description

  • Oversee a team of AD scientists for method development/optimization, validation, transfer, daily/weekly planning, and execution of experiments.
  • Provide analytical expertise and technical support for all phases of drug development, including new product introduction, process development, plant investigations, and regulatory activities.
  • Lead analytical projects for new product introductions to the site, including method assessment, development, validation/qualification, and transfer.
  • Provide technical and analytical support to resolve operational, technical, and analytical issues within the Analytical Development (AD) laboratory.
  • Promote and supervise GMP/Safety standards within the AD group to maintain an inspection-ready facility.
  • Coordinate with clients, project management, manufacturing, QC, and PDS teams; share periodic project updates.
  • Participate in developing the AD group as a center of excellence and in capability building and competency development.
  • Create schedules for team members and provide performance feedback.
  • Motivate the team to perform efficiently and timely.
  • Participate in regulatory and customer audits.
  • Support AD manager in budgeting and recruitment.

Laboratory GMP Compliance

  • Obtain working knowledge of all relevant site and analytical SOPs.
  • Maintain laboratory notebooks and testing sheets in GMP compliance.
  • Carry out calibration of equipment and balances; ensure validation/calibration documentation is signed off.
  • Maintain good housekeeping, conduct audits, and report deficiencies.
  • Participate in internal and external audits.
  • Maintain training records and participate in training team members.
  • File data appropriately and facilitate archiving.

Technical Support or Troubleshooting for Existing Products

  • Provide technical data/opinions to internal and external customers.
  • Participate in cross-functional meetings and deviation investigations.
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Research, Analyst, and Information Technology
Industries
  • Biotechnology

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