Principal Scientist, Analytical Development and QC

Company: Foghorntx
Location: Cambridge
Posted on: October 28, 2024

Job Description:

Our Culture: Why work with us?At Foghorn Therapeutics, we believe in "People First, Mission Always."We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community speaking more than 22 languages and representing over 24 nationalities. We value our teammates as people, not just as employees - validated by our actions that let our people know that we care about them, their families, and their lives.We say "Mission Always" because we know a relentless commitment to our mission will make a difference in the lives of others. We believe our success will come from evaluating the data to follow the science. We work hard to develop a new class of therapies that could improve the lives of over 2.5 million people with cancer.Our culture is focused on succeeding through the evaluation of data, not people. And in that, relationships can flourish and develop.Our Science:The groundbreaking science behind our therapies continues to yield vital insights into diseases that have confounded physicians and researchers. Our core scientific approach is centered on the chromatin regulatory system, which opens and closes the right sections of DNA at the right time. Breakdowns in the chromatin regulatory system lead to a wide range of diseases, including cancer, impacting millions of people.Our proprietary Gene Traffic Control platform is a powerful tool for understanding and modulating the chromatin regulatory system. We are pursuing multiple treatments for breakdowns in this system. We are the only company with the ability to study and target the chromatin regulatory system at scale, in context, and in an integrated way.Job SummaryThe Principal Scientist of Analytical Development and QC at Foghorn Therapeutics will drive 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. The successful candidate needs to demonstrate hands-on novel analytical development skills and a proven track record of managing CROs and CDMOs. Experience with long acting injectable product development is a plus. This position will report to the Vice President of CMC, Supply Chain, Quality Assurance.This role is on-site.Responsibilities

• Develop novel analytical method for long-acting injectable product hands-on at internal CMC lab
• 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.
• Develop and implement a phase-appropriate quality control strategy for both drug substances and drug products.
• Manage product stability study programs to ensure compliance and efficacy.
• Author analytical development and validation reports, as well as analytical sections for IND and NDA filings.
• 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.
• Serve as the CMC representative on cross-functional project teams to ensure alignment and integration of analytical development with broader project goals.Qualifications
  • PhD in Analytical Chemistry or related field with 10+ years of analytical development experience in the pharmaceutical industry.
  • A desire to develop novel analytical method at internal CMC lab for long acting injectable product
  • 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.
  • Excellent scientific knowledge in analytical and organic chemistry.
  • Proficient in analytical method development and validation.
  • Comprehensive knowledge of quality control strategies for drug substances and drug products.
  • Effective verbal and written communication skills.
  • Proven ability to work successfully in cross-functional teams, representing the CMC function.
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Keywords: Foghorntx, Chelsea , Principal Scientist, Analytical Development and QC, Other , Cambridge, Massachusetts