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Associate Director, Analytical Development and Quality Control
2 months ago
Foghorn Therapeutics is seeking an experienced Associate Director to lead our Analytical Development and Quality Control functions. As a key member of our team, you will be responsible for driving the development and validation of analytical methods, ensuring the successful advancement of small molecule candidates from preclinical through NDA.
About the RoleThis is an exciting opportunity to join a dynamic team and contribute to the development of innovative therapies. As Associate Director, you will be responsible for:
- Developing novel analytical methods for long-acting injectable products
- Leading and overseeing CRO/CDMO partnerships in the development and validation of analytical methods
- Developing and implementing phase-appropriate quality control strategies for drug substances and drug products
- Managing product stability study programs to ensure compliance and efficacy
- Authoring analytical development and validation reports, as well as analytical sections for IND and NDA filings
To be successful in this role, you will need:
- A PhD in Analytical Chemistry or a related field with 10+ years of analytical development experience in the pharmaceutical industry
- A proven track record of developing analytical methods and managing CROs and CDMOs on analytical projects
- Extensive experience in drafting analytical sections of INDs and NDAs
- Demonstrated ability to draft, review, and submit documentation in compliance with cGMP and GLP environments
- Strong background in implementing phase-appropriate quality control strategies
Foghorn Therapeutics is committed to providing a comprehensive benefits package, including:
- Highly competitive medical, dental, and vision coverage options
- FSA and HSA for medical expenses and dependent care expenses
- 401(k) Program via Fidelity with the company match
- Corporate Wellness Program
- Unlimited Paid Time Off policy
- 12 weeks of 100% paid parental leave for birthing/primary parent and primary guardian in case of adoption and 3 weeks of 100% paid parental leave for non-birthing/non-primary parent/guardian
Foghorn Therapeutics is an equal opportunity employer and welcomes applications from diverse candidates.
