Replimune is a fast-paced growing innovative company that is pioneering a novel class of oncolytic immunotherapies designed to kill a tumor locally, alter the tumor microenvironment, and ignite a powerful patient-specific immune response. These transformational new therapies are being developed to be tolerable and treat difficult-to-treat cancers.  The Replimune Framingham (MA) production facility was purposefully designed to manufacture our Oncolytic Immunotherapies.  This multi-product facility contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space.

The Associate Director – Process Technology is responsible for the leadership of an organization that identifies, evaluates, and implements new and existing materials and technologies to improve process efficiency, control, and understanding for all RPx products (drug substance and drug product production).  The incumbent will ensure that all work within this area is planned, performed, and reported in an efficient and compliant manner.  The AD – Process Technology is the knowledge expert / manager for process materials (e.g. PERLs and E&L).  In addition, this person manages personnel / assists in conducting tech transfer / process support of drug substance and drug product manufacturing process / technology transfer (e.g. scale-up, process validation, GMP production capacity expansion, etc.).  This team collaborates with other CMC groups, F&E, validation, and QA to design and improve process steps within the cGMP production processes. 

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Key responsibilities:

• Leadership and direction of the Process Technology group at Replimune.
• Provide technical input to the optimization of processes for the manufacture of cGMP materials.
• Provide technical leadership to troubleshoot issues with drug substance and drug product processing technologies and equipment
• Supervises timely creation, completion and archiving of records, protocols and technical reports to document the development, characterization and technology transfer pf production processes / new technology implementation.
• Assist in the preparation of department expense, capital, and headcount budget.
• Preparation of reports and regulatory documents in support of submissions to regulatory authorities.
• Drive continuous improvement in our cGMP process steps through technological innovation and application of experimental findings.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
• Deep experience with drug product technologies (e.g. biologics lyophilization) and/or active virus formulation development is preferred

Other responsibilities

• Responsible for management of direct reports
• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Auditing external suppliers / CMOs
• Provide review and approval of SOPs, risk assessments, protocols and reports.
• Provide regular updates of group activities to the Senior Director of Process Development and other Replimune senior management.
• Keeps up to date with current technologies and trends in biologics processing
• Other duties as assigned
• Some travel may be required, both in country and international.

Educational requirements:

• A or B.S. degree in a relevant biological science and extended relevant commercial experience.
• S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred

Experience and skill requirement:

• A minimum of 10 years’ experience (BS) or 6 to 8 years (MS/PhD) supporting cGMP production of biologics
• Thorough understanding of current regulatory requirements and practical experience in support of cGMP operations, specifically technology development and implementation and process transfer
• Proven leadership in managing and motivating team members to achieve goals
• Ability to interface effectively with management and other groups or project teams
• Previous exposure and appreciation for a well-maintained process materials risk assessment and leachable monitoring program.
• Experience in statistical analysis
• Excellent verbal and written communication skills
• Good organizational skills

Location: 

This position is based in our Framingham location and typically has a 5-day on-site expectation.