Senior Manager, Process Chemistry, Drug Substance, Dev. & Manufacturing

The Role:

We seek a highly motivated, experienced process chemist to join our growing CMC team, headquartered in Burlington, MA, and report to the Senior Director of drug Substance development and manufacturing. This individual will be critical in overseeing external manufacturing partners and advancing drug substance development activities for small-molecule therapeutics.

Here’s What You’ll Do:

• Collaborate with CROs/CDMOs to resolve process chemistry challenges and develop robust, scalable, safe, and cost-effective manufacturing processes.
• Review process development reports, technical documents, and batch records with strong attention to detail.
• Coordinate weekly meetings with external partners to track project progress, review data, and provide technical feedback.
• Support investigations related to deviations and OOS/OOT results 
• Assist in drafting CMC sections of regulatory submissions (e.g., IND, IMPD).
• Work cross-functionally with Analytical, Formulation, Quality, and Regulatory teams to ensure alignment and successful execution of deliverables. 

Here’s What You’ll Bring to the Table:

• Ph.D. in Organic Chemistry with 3–6 years of relevant industry experience, or MS with 6–12 years in process chemistry, ideally in biotech or CDMO environments.
• Proven experience in small-molecule drug substance process development, scale-up, and cGMP manufacturing.
• Experience in managing external CRO/CDMO partnerships.
• Knowledge of ICH/cGMP guidelines and early-phase development. 
• Excellent communication and technical writing skills.
• Ability to manage projects in a dynamic, fast-paced environment.
• Willingness to participate in CDMO’s teleconferences outside regular business hours when needed.

Here’s What We’ll Bring to the Table:

• Highly competitive benefits package including 
• Blue Cross Blue Shield PPO, Delta Dental, and VSP vision 
• Fully funded HSA for high-deductible PPO Plan
• 401k (traditional and Roth offered) with 100% match on first 4% deferred. The match is vested immediately
• A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability insurance
• Flexible Spending Accounts for medical and dependent care expenses
• 4 weeks of Paid Time Off annually 

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law