Analytical Development Manager

5 days ago

Mississauga, Ontario, Canada Eurofins GSC Poland Sp. z o. o. Full time

About the Role:

We are seeking an experienced Analytical Development Manager to join our team at Eurofins GSC Poland Sp. z o. o.

The successful candidate will be responsible for overseeing and executing analytical services in support of Drug Product development and GMP operations, including method transfer, method development, and phase appropriate method validation.

Key Responsibilities:

  • Draft GMP documentation such as test methods, material/product specifications, protocols, and SOPs as required
  • Develop and execute analytical methods in support of oral drug product development, including Assay, Impurity, Dissolution, Water Content, and Residual Solvent
  • Conduct OOT/OOS/Deviation investigations as required
  • Troubleshoot, maintain, and perform equipment qualifications for HPLC's, GC's, KF, and other analytical equipment as required
  • Conduct prototype and GMP stability studies in accordance with ICH or other regulatory guidelines
  • Ensure all work is performed in compliance with applicable SOPs, cGMPs, and GLPs
  • Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures
  • Other duties as assigned

Requirements:

  • B.Sc. or M.Sc. in Chemistry with >10 years experience or Ph.D in Chemistry with >5 years experience in the pharmaceutical-related field industry
  • Must have a strong knowledge of drug product development and hands-on experience in analytical development
  • Must be highly motivated and have a proven record of success in multiple projects
  • Must be well organized and able to meet project timeline commitments
  • Must work well in a multi-disciplinary team environment and have excellent written and verbal communication skills

Salary: Estimated $120,000 - $180,000 per year, depending on experience

Benefits: Excellent full-time benefits, including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, and paid time off

Location: GTA, Ontario

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