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Senior Director, Pharmaceutical Development
3 months ago
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.
- 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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