Associate Director, Formulation
- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Precision therapeutics for genetically defined diseases. Real solutions for real challenges.
Who We Are
Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, PLX9486 (expected to be named CGT9486 in the future), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis which can severely impact many different tissues and organs in the body. We are also studying PLX9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.
What You Will Do
- Design, execute and lead pre-clinical and clinical formulation development efforts and associated manufacturing in the development of solid oral dosage forms in clinical studies and potential commercialization.
- Provide technical support and day-to day management of outsourced drug product development activities with CMO partners
- Manage manufacturing activities that will include monitoring production campaigns, reviewing of batch records and process analytical batch data
- Present technical data to cross functional teams and senior management as needed
- Oversee Tech Transfer and validation activities on multiple projects
- Provide regulatory filings support by authoring and reviewing CMC sections as needed
- Support any quality investigations or events and resolve them in a timely manner
What You Bring
- Demonstrated expertise in several drug product development activities such as phase appropriate formulation development, formulation characterization and optimization
- Proven track record in developing and scaling up formulations for oral administration from Pre-IND through late stage development.
- Recognized as a subject matter expert in the development of oral formulations with experience in one or more formulation techniques such as solubilization, spray drying, hot melt extrusion, nanoparticles, dry granulation, wet granulation, tablet compression, tablet coating and encapsulation etc.
- Knowledge and the ability to use and understand data from common analytical techniques such as HPLC, DSC, TGA, XRPD, IR/Raman spectroscopy and particle size analysis techniques required to support product development
- Background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD) is preferred.
- Ability to troubleshoot formulation issues, determine causes and possible solutions
- Proven knowledge of cGMPs and associated regulatory, quality compliance considerations in the pharmaceutical environment
- Ph.D. and 8+ years of relevant work experience. Candidates with MS degree will require additional working experience
Cogent is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.
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), unlimited time-off, a 401(k) plan, and commuter/parking benefits.
- Cogent is an equal opportunity employer
- Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals