Process Development Senior Scientist, Drug Product
About The Position
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Working in collaboration with cross functional teams, the Process Development Senior Scientist will be responsible for leading process characterization and product characterization studies, providing subject matter expertise and practical technical support for GMP drug product production processes, optimization and improvement of GMP DP process steps and PD workflows supporting these efforts. This position will also represent PD as part of DP process validation exercises and in support of product commercialization. This position is based in our Framingham location and typically has a 5-day on-site expectation.
Requirements
- Bachelor’s degree in applicable field with advanced degree preferred
- Minimum of 2 year working in a biologics drug product process development role.
- Demonstrated ability to work in cross-functional teams across the business.
- Experience with frozen liquid and lyophilized drug product formulation development
- Strong organizational skills and attention to detail.
- Excellent written and oral communication skills and strong team player
- Experience with technology / assays to measure size and concentration of sub-visible and sub-micron particles (e.g. nanosight and flow cam)
Responsibilities
- Execution of late stage drug product process characterization and product characterization studies to support PPQ, BLA, and Commercial readiness.
- Project management / execution of experiments to develop stable formulations for Replimune products
- Author protocols, reports, risk assessments, SOPs, and batch records
- Serve as a drug product process subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, and corrective, and preventative actions.
- Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of alternative technologies
- Actively contribute to cross functional teams to achieve production site and company goals in support of commercial production readiness
- Assist with authoring sections of applicable regulatory filings
- Practices and promotes safe work habits and adheres to safety procedures and guidelines
- Provide technical representation during internal and external audits
- Keeps up to date with current technologies and trends in biologics manufacturing operations and support
- Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance.
Benefits
- medical, dental, and vision insurance
- 401k match
- flexible time off
- a number of paid holidays including year-end shutdown
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
