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Associate Director, Analytical Development
Full Time
Boston, Massachusetts, United States (This job is on-site)
Job description
Scismic is supporting the growth of a clinical-stage oncology company in Boston, MA!
We are looking for a Senior Scientist/Lead Scientist that is ready to make the next move to an Associate Director role!
Reporting to the Senior Vice President, Head of CMC you will be responsible for setting analytical development and control strategies for small molecule drug substance and drug product manufacture in support of clinical development and eventual commercialization. Responsible for oversight of day-to-day management of analytical activities at contract manufacturing organizations. Ensure practices are in conformance with current global regulatory and compliance standards and company quality standards.
Your Role
- The Associate Director will be a key decision maker reporting to the Head of CMC
- This role will support drug development as they advance from discovery to clinical phases
- The ability to develop creative solutions to overcome project challenges and meet project timelines in a fast-paced environment is essential
- Represent analytical function on cross-functional and project teams
- Serve as a Subject Matter Expert to lead analytical development activities for both drug substance and drug product
- Provide science-based guidance to aid in the advancement of assets to the clinic
- Develop phase appropriate control strategies to support the company's pipeline, identify and overcome analytical obstacles in a timely manner to meet project timelines
- Propose and justify drug substance and drug product specifications
- Design stability studies for drug substance and drug product and justify retest/expiry period, storage, and shipping conditions
- Understand chemical development, solid state development and formulation development
- Develop, verify, validate, and transfer (as applicable) analytical methods
- Identify critical in-process-control issues and develop appropriate IPC methods
- Manage and oversee external CRO/CDMO on all analytical activities to ensure timely develop, manufacture and delivery of both non-GMP and GMP DS and DP
- Authors appropriate CMC sections to support regulatory submissions, such as IND, IMPD, etc
- Author, review and approve analytical data package, technical protocol/reports, and SOPs
- ~10% Travel required
- Perform other related duties as assigned
Your Background
- PhD in Analytical Chemistry or related field with 8 plus years of experience or MS in Chemistry with 12 plus years or experience in the biotech/pharmaceutical industry
- Experience in a leadership role is preferable
- Experience in Analytical Chemistry within the Pharmaceutical Industry with a proven track record of effectively advancing assets into the clinic
- General understanding of the drug development process, including chemical/process development, solid state development, and formulation development, and the interrelationship with analytical development
- Thorough understanding of ICH, FDA and USP guidelines, including the ability to apply the guidelines in context of the stage of pharmaceutical development
- Excellent interpersonal and team skills
- Excellent verbal and written communication skills
- Able to work effectively in a hybrid team environment