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Product Development Project Manager in Oakville at Apex Life Sciences

Date Posted: 12/5/2018

Job Snapshot

Job Description


Product Development - Project Manager

Apex Life Sciences is searching for a Project Manager for a permanent role in Oakville, ON. Our client is in the pharmaceutical industry and is looking to grow their Product Development team. This position is a senior role with many growth opportunities. We are seeking Project Managers with chemistry backgrounds and with extensive project management, CMC technology transfer, method development, method validation and leachables/extractables experience.

 Job Responsibilities:

  • Management of new product development and CMC technology transfer for analytical and formulation development activities with external partners
  • Writes and reviews development protocols for regulatory submissions under strict time deadlines
  • Support the analytical testing such as leachables/extractables and filter validation with external partners
  • Supports the Scientific and Regulatory Affairs team – designing and managing internal research and responding to any questions and comments from regulatory agencies under tight deadlines
  • Collaborate with the internal Quality department to troubleshoot any issues related to OOS/OOT investigations
  • Identify areas of improvement within the New Product Development team and create appropriate solutions
  • Manage budgeting criteria for the new product developments

Required Qualifications:

  • Minimum M.Sc. in chemistry or related.
  • 10+ years experience with analytical method development, validation, formulation development,  and technology transfer in the pharmaceutical industry
  • Excellent project management and technical writing skills
  • Experience with injectable pharmaceutical products is an advantage
  • Excellent interpersonal, communication (both oral and written) and organizational skills
  • Thorough knowledge of regulatory CTDs and Modules
  • Strong analytical and problem-solving skills

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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