Senior Scientist, Drug Product
About this role
Overview
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.
Summary of job description:
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. - ·Representing 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.
.Key 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
· Experience with technology / assays to measure size and concentration of sub-visible and sub-micron particles (e.g. nanosight and flow cam)
· 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.