Analytical Development Manager at Thermo Fisher Scientific
Overview
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Responsibilities
* 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 to support the introduction of new products, process development, plant investigations and regulatory activities.
* Lead analytical projects for the introduction of new products to the site, including method assessment, method development, validation/qualification and transfer.
* Provide lead technical and analytical support to the team for resolution of operational, technical and analytical issues within the Analytical Development (AD) laboratory.
* Promote and supervise laboratory GMP / Safety within the Analytical Development (AD) group such that the AD laboratory is maintained as an inspection-ready facility.
* Coordinate with client, project management, manufacturing, QC and PDS teams and share periodic updates on assigned projects.
* Actively participate in the development of the AD group as a centre of excellence and drive competency development.
* Create schedules for team members and provide feedback on their performance; motivate the team to perform timely and efficient work.
* Participate in regulatory and customer audits.
* Support AD manager on budgeting and recruitment.
Laboratory GMP Compliance
* Obtain a working knowledge of all relevant site and analytical SOPs.
* Maintain laboratory notebooks and proforma testing sheets in compliance with GMP requirements.
* Carry out calibration of equipment and analytical balances as required.
* Ensure that validation/calibration documentation associated with instrumentation is appropriately signed off before use.
* Maintain good housekeeping standards; carry out laboratory housekeeping audits and self-inspections; complete assigned actions in a timely manner and report any deficiencies.
* Participate in internal and external audits as required.
* Maintain individual training records on an ongoing basis; participate in the training of team members as appropriate.
* File all data as appropriate and facilitate appropriate archiving.
Technical Support or Troubleshooting for Existing Products
* Provide technical data/opinion to both internal and external customers where required.
* Participate in cross-functional meetings/teleconferences (internal and external) as appropriate.
* Participate in deviation investigations as required.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Production, Supply Chain, and Manufacturing
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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