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Associate Director of Analytical Development
2 months ago
The Associate Director of Analytical Development will lead a team of analytical scientists responsible for the development, manufacturing, release, and stability testing of drug substances and drug products. This role will provide leadership, guidance, and strategic direction to the team, ensuring staff are developed to their fullest potential.
Key Responsibilities- Provide leadership to the team in the development of scientific capability and analytical strategies.
- Ensure strong cross-functional collaborations and integrated process and product development and characterization.
- Develop and execute strategies and process characterization with a focus on product quality assessment, specification, release, stability, and comparability studies.
- Collaborate with process, formulation, and quality functions to ensure successful analytical strategies are positioned and implemented.
- Author, review, and/or approve key source documents for regulatory filings.
- Lead and track analytical development commitments to support CMC filing activities.
- M.S. or Ph.D. degree in analytical chemistry, chemistry, or chemical engineering with pharmaceutical industry experience.
- 10 or more years of analytical development experience.
- 3 or more years of experience in late-stage product and process development and market application of small molecule or oligonucleotide therapeutics.
- 3 or more years of people management and analytical project leadership experience.
- 5 or years of experience in analytical assay development, qualification, and validation.
- 2 or more years of experience in methods tech transfer and life cycle management.
- Exposure to all stages of drug development.
- Proven ability to manage projects and work with cross-functional teams.
- Experience with mRNA, peptides, and conjugated biologic therapeutics modalities.
- Ability to work in a fast-paced, multi-disciplinary environment with flexibility to support multiple development programs simultaneously.
