Senior Scientist, Drug Product at Replimune in Framingham

Job description

• Application
• 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
• · 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.
• · 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
• · Additional duties and responsibilities as required
• · 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

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

Skills

Required

• GMP drug product production
• Process characterization
• Product characterization
• Regulatory filings
• cGMP process steps
• Laboratory tasks

Benefits

• Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $146,000 -$189,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.
• At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.