Senior Manager / Associate Director, Formulation

Who We Are

Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.

Our Team

https://cogent.culturehq.com

• Designs, executes and leads preformulation studies, pre-clinical and clinical formulation development efforts and associated manufacturing in the development of solid oral dosage forms in clinical studies and potential commercialization.
• Provides technical support and manages manufacturing activities with CMO partners that will include monitoring production campaigns, reviewing of batch records/protocols/reports etc.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes technical reports and presents technical data to cross functional teams.
• Supports any quality investigations or events and resolves them in a timely manner.
• Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring and review of requisite sections of the IND, IMPD or other filings.
• Adheres to cGMP work practices and works closely with the Quality organization to ensure strict compliance with applicable GXP procedures and compliance requirements.
• Other responsibilities as assigned.

• PhD+8, or MS/BS +10 in Pharmaceutical Sciences or equivalent combination of relevant education and applicable job experience may be considered.
• 8+ years of relevant experience in pharmaceutical manufacturing and early-stage experience such as preformulation, pre-clinical and clinical formulation and process development and process scale-up with a focus on oral solid dosage forms.
• Experience in formulation techniques such as solubilization, granulation, tablet compression, coating is required.
• Experience in developing advanced drug delivery systems for enhancing drug permeability or solubility is required.
• Experience in managing CMOs for formulation and process development, clinical manufacturing and scale up.
• Background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD) is preferred.
• Extensive knowledge of cGMP requirements for drug product manufacture as well as broader drug development guidelines (ICH, FDA, and EMA) and past experience in development of INDs.
• Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory filings.
• Attention to detail and quality are critical to success.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Flexibility to travel domestically and internationally.

Our Locations

Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.

Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor.  Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.