Senior Scientist, Drug Product

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.

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 cGMP process steps 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; Some travel may be required, both in country and international; Additional duties and responsibilities as required

Requirements

Bachelor's degree in applicable field; Minimum of 2 years 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

Nice to have

Advanced degree preferred; Experience with technology/assays to measure size and concentration of sub-visible and sub-micron particles (e.g. nanosight and flow cam)

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown