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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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