Infinity Pharmaceuticals is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

The Senior Manager/Associate Director, Chemical Engineering will work closely with CMC teams on the design, improvement, and monitoring of our manufacturing processes (drug substance and drug product) as they progress from laboratory scale to fixed equipment. In addition, they will oversee on-going and future large scale manufacturing activities.

Primary responsibilities:

§   Work closely with Process Chemistry and Drug Product development teams to design robust processes which enable laboratory through commercial scale production. Provide input regarding application of technologies and approaches to yield safe, robust, productive and practical processes. Provide expertise in process development and engineering including design, scale-up, equipment selection, process optimization, technology transfer and validation.

§   Work with CMC teams to evaluate and select appropriate Contract Manufacturing Organizations (CMOs), providing technical support for all phases of the commissioning, start-up and validation of contract manufacturing projects.

§   Following start-up, work with CMOs to manage the tracking and control of manufacturing process performance, ensuring the creation and revision of appropriate regulatory records and documents.  Maintain the production schedule and provide input on the supply chain strategy.

Education and Experience Required:

§   PhD in Chemical Engineering with > 4 years of experience or BS/MS in Chemical Engineering, with > 8 years of experience in process development and scale-up of drug substance (DS) manufacturing processes.

§   Successful track record and technical expertise in the development, transfer and scale-up of DS manufacturing processes is required.  In addition, hands-on experience with GMP chemical pilot plant operations is required. Experience with commercial manufacturing operations is highly desirable.

§   Demonstrated ability to work cross-functionally with integrated product development teams, interfacing seamlessly with disciplines such as Process Chemistry, Formulation Science, Analytical Chemistry, Quality Assurance and Regulatory Affairs.

§   Experience managing technology transfer and production at CMOs is required.

§   Understanding and knowledge of cGMP is required. Knowledge of FDA, DEA, OSHA and EPA expectations for pharmaceutical chemical operations is desired.

§   Must demonstrate exceptional leadership, problem solving and organizational skills.

§   Solid written and oral communication skills.

§   Title will be commensurate with experience.