Senior Director, Pharmaceutical Development

4 weeks ago

Québec QC, Canada Groom Associes Full time

Under the direct supervision of the CEO, the Senior Director of Pharmaceutical Development will spearhead the implementation and execution of pharmaceutical development strategies in close collaboration with the Bioproduction and Preclinical Studies & Laboratory teams to advance our client's project portfolio. This role will also actively contribute to the pharmaceutical development process in coordination with clinical and regulatory functions.

Responsibilities

  • Collaborate closely with Regulatory and Clinical teams to craft pharmaceutical development strategies for manufacturing medicinal substances to support clinical studies.
  • Strategize, coordinate, and ensure the successful execution, in partnership with Bioproduction and Preclinical Studies & Laboratory teams, of pharmaceutical development plans to meet both regulatory requirements and organizational objectives.
  • Innovate processes and oversee their scalability in accordance with regulatory standards and Good Manufacturing Practices (GMP).
  • Design and conduct developmental and process characterization studies across both laboratory and pilot scales.
  • Provide regular updates on project progress and proactively address any issues that may impact goal attainment.
  • Prepare and review technical documentation, including research reports, development summaries, and manufacturing-related documents.
  • Foster cross-functional collaboration with Bioproduction, Preclinical Studies & Laboratory, and Quality teams to drive project success.
  • Contribute to the preparation of specifications, standard operating procedures (SOPs), and other essential documents for pharmaceutical product operations.
  • Assist in the development and revision of regulatory documentation as necessary.
  • Provide support and guidance for analytical activities, including method development, validation, transfer, and analysis within Research & Development (R&D) and GMP environments.
  • Participate in investigative processes as required.
Qualifications
  • Hold a Bachelor's degree in a scientific field (e.g., pharmacy, chemistry, biology) with a minimum of 3-5 years' experience in a comparable pharmaceutical development setting.
  • Possess specialized expertise in formulating bioprotein formulations, vaccines, and biological products.
  • Demonstrate proficiency in bioprotein purification techniques and analytical methodologies such as SDS-PAGE, Western Blot, ELISA, etc.
  • Show proven experience in scaling up manufacturing and purification processes for bioproteins.
  • Have knowledge of GMP requirements (e.g., Health Canada, FDA, EMA) and familiarity with USP and EP pharmacopoeias.
  • Exhibit the ability to excel in a fast-paced environment with frequent disruptions.
  • Demonstrate strong prioritization skills.
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