Manager Development Quality Assurance

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/

Job Summary:   Cogent Biosciences is growing!  This position plays a crucial role within the company representing quality on development projects for Cogent Bioscience therapies. The ideal candidate will have a strong understanding of cGMPs, FDA and ICH guidance, and excellent writing abilities. They would have a seat at the table where they could intellectually contribute and work with a multi-disciplinary team with the common goal of bringing forward innovative cancer therapies.

What You Will Do:

• Provide quality input for the development of Cogent’s early-stage candidates
• Quality review of master and executed batch records for the manufacture and packaging of drug substance and drug products
• Coordinate and participate in quality investigations (including OOS/OOT investigations, manufacturing deviations, etc). Work alongside impacted functions in the development of required CAPA items
• Oversee/Coordinate quality tasks at drug substance and drug product CDMOs
• Work with Analytical Development in the creation of analytical methods for early-stage candidates
• Assess CDMOs from a QA perspective for the manufacture, testing, and development of early-stage candidates
• Oversee and review stability program - protocol review, stability pull points, and final report review
• Provide QA support during manufacturing and analytical operations
• Support Risk Assessment initiatives in close collaboration with internal and external interfaces
• Support CMC, analytical, logistics, and regulatory functions as needed
• 15-20% of the job will require traveling

What You Bring:

• Bachelor’s Degree in Science (required); Preferably in Pharmaceutical Sciences or Technology, Chemical Engineering, etc.
• Minimum of 5-7 years of relevant experience in a pharmaceutical quality assurance/control environment
• Experience overseeing the quality activities for the manufacture and development of early small molecule products
• Self-motivated and demonstrated success in working with cross-functional teams
• Must be detail oriented with proven abilities to meet deadlines
• Excellent interpersonal, written, and verbal communication skills