Senior Director of Analytical Development and Quality Control
4 days ago
Company Culture: Why Choose Us?
At Foghorn Therapeutics, we prioritize a "People First, Mission Always" ethos. Our team is our greatest asset, and we embrace the rich diversity of backgrounds, ideas, and experiences that our members contribute. With over 22 languages spoken and representation from more than 24 nationalities, we recognize our employees as individuals, valuing their well-being and that of their families.
Our unwavering commitment to our mission drives us to make a meaningful impact in the lives of others. We are dedicated to leveraging data to inform our scientific endeavors, aiming to develop innovative therapies that can transform the lives of over 2.5 million individuals affected by cancer.
Our culture emphasizes success through data evaluation rather than individual assessment, fostering an environment where relationships can thrive.
Scientific Innovation:
The pioneering science behind our therapies provides critical insights into complex diseases that challenge healthcare professionals and researchers. Our foundational scientific approach revolves around the chromatin regulatory system, which precisely regulates DNA accessibility. Disruptions in this system can lead to various diseases, including cancer, affecting millions globally.
Our proprietary Gene Traffic Control platform serves as a robust mechanism for comprehending and modulating the chromatin regulatory system. We are uniquely positioned to investigate and target this system comprehensively and contextually.
Role Summary
The Senior Director of Analytical Development and Quality Control at Foghorn Therapeutics will spearhead the analytical development and quality control initiatives, ensuring the successful progression of small molecule candidates from preclinical stages through to NDA for both drug substances and products. The ideal candidate will exhibit hands-on expertise in innovative analytical development and possess a proven history of managing CROs and CDMOs. Experience in the development of long-acting injectable products is advantageous. This role will report directly to the Vice President of CMC, Supply Chain, and Quality Assurance.
This position requires on-site presence.
Key Responsibilities
- Develop innovative analytical methodologies for long-acting injectable products at our internal CMC laboratory.
- Lead and manage partnerships with CROs and CDMOs in the development and validation of analytical methods, employing phase-appropriate strategies for assays, purity assessments, dissolution techniques, impurity identification, degradation analysis, reference standard qualification, and physical characterization.
- Establish and execute a phase-appropriate quality control framework for both drug substances and products.
- Oversee product stability study programs to ensure compliance and efficacy.
- Draft analytical development and validation reports, as well as analytical sections for IND and NDA submissions.
- Collaborate with QA, Regulatory Affairs, and other CMC functions, as well as clinical and toxicology teams, to address safety-related inquiries regarding APIs, API components, formulations, and processing materials.
- Act as the CMC representative on cross-functional project teams to ensure alignment and integration of analytical development with broader project objectives.
Qualifications
- PhD in Analytical Chemistry or a related discipline with over 10 years of analytical development experience in the pharmaceutical sector.
- A passion for developing innovative analytical methods at our internal CMC laboratory for long-acting injectable products.
- Demonstrated success in developing analytical methods and managing CROs and CDMOs on analytical projects.
- Extensive experience in drafting analytical sections for INDs and NDAs.
- Proven ability to draft, review, and submit documentation in accordance with cGMP and GLP standards.
- 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 understanding of quality control strategies for drug substances and products.
- Exceptional verbal and written communication skills.
- Proven ability to work effectively in cross-functional teams, representing the CMC function.
Benefits
Foghorn Therapeutics offers a comprehensive benefits package for you and your family, including:
- Highly competitive and inclusive medical, dental, and vision coverage options.
- BCBS PPO and PPO HSA plans.
- BCBS Dental Plan.
- EyeMed Vision Plan.
- Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA) for medical and dependent care expenses.
- 401(k) program via Fidelity with company matching.
- Corporate wellness initiatives.
- Unlimited paid time off policy.
- Winter shutdown.
- 12 weeks of fully paid parental leave for birthing/primary parents and primary guardians in cases of adoption, along with 3 weeks of fully paid parental leave for non-birthing/non-primary parents/guardians.
- Paid life, long-term disability, and short-term disability insurance, along with voluntary benefit options.
- Free parking, subsidized commuter passes, or a monthly stipend for walking or biking to work.
- Company-sponsored lunches on Wednesdays.
Foghorn Therapeutics maintains a smoke-free, alcohol-free, and drug-free workplace. We are committed to equal employment opportunities and non-discrimination for all employees and qualified applicants, regardless of race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected by applicable law. We will provide reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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