Senior Scientist, Biologics Process Development

Replimune; Framingham, Northern (MA, KY); Hybrid; USD 146,000 - 189,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune is seeking a Process Development Senior Scientist to lead late-stage DP process characterization and product characterization studies in Framingham. You will collaborate across functions and support PPQ, BLA, and commercial readiness, developing stable formulations for Replimune products.

The role requires 2+ years in biologics DP process development, cross-functional collaboration, and strong communication and organizational skills.

Qualifications

• Minimum 2 years working in a biologics drug product process development role.
• Experience working 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.

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.

Skills

Biologics

Cross-functional collaboration

Communication skills

Organizational skills

Education

Bachelor's degree

Job description

Replimune is seeking a Process Development Senior Scientist to lead late-stage DP process characterization and product characterization studies in Framingham. You will collaborate across functions and support PPQ, BLA, and commercial readiness, developing stable formulations for Replimune products.

The role requires 2+ years in biologics DP process development, cross-functional collaboration, and strong communication and organizational skills.