Senior Analytical Development and Quality Control Specialist

3 days ago


Cambridge, Massachusetts, United States Foghorn Therapeutics Full time
About the Role

Foghorn Therapeutics is seeking a highly skilled and experienced Senior Analytical Development and Quality Control Specialist to join our team. As a key member of our CMC function, you will be responsible for driving the analytical development and QC functions, ensuring the successful advancement of small molecule candidates from preclinical through NDA for both drug substances and drug products.

Key Responsibilities
  • Develop Novel Analytical Methods: Develop novel analytical methods for long-acting injectable products at our internal CMC lab.
  • Lead CRO/CDMO Partnerships: Lead and oversee CRO/CDMO partnerships in the development and validation of analytical methods, utilizing phase-appropriate approaches for assays, purity, dissolution methodologies, impurity identification, degradation products, reference standard qualification, and physical characterization.
  • Implement Quality Control Strategy: Develop and implement a phase-appropriate quality control strategy for both drug substances and drug products.
  • Manage Product Stability Studies: Manage product stability study programs to ensure compliance and efficacy.
  • Author Analytical Reports: Author analytical development and validation reports, as well as analytical sections for IND and NDA filings.
  • Collaborate with Cross-Functional Teams: Collaborate with QA, Regulatory, and other CMC functions, clinical, and toxicology teams to address safety-related questions on APIs, components of APIs, formulations, and materials used in processing.
  • Represent CMC Function: Serve as the CMC representative on cross-functional project teams to ensure alignment and integration of analytical development with broader project goals.
Requirements
  • PhD in Analytical Chemistry or Related Field: PhD in Analytical Chemistry or related field with 10+ years of analytical development experience in the pharmaceutical industry.
  • Desire to Develop Novel Analytical Methods: A desire to develop novel analytical methods at our internal CMC lab for long-acting injectable products.
  • Proven Track Record: Proven track record of developing analytical methods and managing CROs and CDMOs on analytical projects.
  • Extensive Experience: Extensive experience in drafting analytical sections of INDs and NDAs.
  • Strong Background: Strong background in implementing phase-appropriate quality control strategies.
  • Excellent Scientific Knowledge: Excellent scientific knowledge in analytical and organic chemistry.
  • Proficient in Analytical Method Development: Proficient in analytical method development and validation.
  • Comprehensive Knowledge: Comprehensive knowledge of quality control strategies for drug substances and drug products.
  • Effective Communication Skills: Effective verbal and written communication skills.
  • Proven Ability to Work in Cross-Functional Teams: Proven ability to work successfully in cross-functional teams, representing the CMC function.


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