Associate Director Drug Substance Manufacturing Development

Who We Are

Cogent Biosciences is a publicly traded 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, bezuclastinib (CGT9486), 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 (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

Our Team

https://cogent.culturehq.com/

The Role

We are seeking an Associate Director responsible for phase-appropriate small molecule drug substance development. This critical hire will bring a strong process development background and experience managing external vendors, and will define and execute on a strategy for synthetic route, process optimization, site transfer, scale-up and validation.

Responsibilities

• Subject matter expert for all aspects of drug substance process and controls.
• Manage daily activities for all drug substance CDMOs.
• Monitor work performed by drug substance CDMOs, including review of protocols, reports, raw data, master and executed batch records.
• Identify development risks/gaps and lead studies to control/manage them.
• Create a robust source documents library and co-author corresponding module 3 sections in Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission.
• Establish and oversee phase appropriate process development plans for drug substance.
• Extensive prior experience managing outsourced development and manufacturing required.
• Ability to travel domestically and international to CDMOs.
• Small molecule drug substance route selection/evaluation scale up and process control development including critical process parameters, critical quality attributes and their acceptance criteria.
• Impurities fate analysis and manufacturing process parameters assessment and overall end-to-end control strategy.
• Working knowledge of ICH guidelines related to cGMP, technology transfers, manufacturing records review and approvals.
• Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization.

Qualifications

• Degree in Organic chemistry - Bachelor’s/Master’s degree with 10+ years of experience or PhD degree with 8+ years of experience.
• Proficient in drug substance production techniques, processing, and characterization of API materials and have CMO management experience.
• Ability to work with diverse stakeholders, both internally and at contract manufacturers.
• Strong knowledge and demonstrated practice of cGMP Guidelines.
• Detail oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
• Ability to troubleshoot problems, work within a team.
• Ability to manage a number of projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.
• Ability to travel internationally and within the USA up to 10 – 30%, as required, to meet project objectives.