Senior Scientist, Drug Product Process Development

Replimune; Framingham (MA); On-site; USD 146,000 - 189,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Flexible PTO

Paid Holidays

Job summary

Replimune in Framingham, MA is seeking a Process Development Senior Scientist who will lead late-stage drug product process characterization, support PPQ and regulatory readiness, and collaborate with cross-functional teams to optimize GMP DP processes.

You will develop stable formulations, contribute to PD workflows, author protocols and batch records, and drive continuous improvement through innovative technologies.

Qualifications

• Minimum 2 years in biologics drug product process development.
• Experience working in cross-functional teams across the business.
• Experience with frozen liquid and lyophilized drug product formulation development.

Responsibilities

• Lead late stage drug product process characterization and product characterization studies.
• Provide SME support for GMP DP production processes and PD workflows.
• Represent PD in DP process validation exercises and regulatory filings support.
• Author protocols, reports, risk assessments, SOPs, and batch records.
• Advise on change controls, deviations, and CAPAs in manufacturing operations.
• Drive continuous improvement in cGMP steps through new technologies and processes.
• Collaborate with site teams to achieve production readiness for commercial use.

Skills

Biologics DP development

Cross-functional teamwork

Formulation development

Documentation & writing

Attention to detail

Education

Bachelor’s degree in applicable field

Job description

Replimune in Framingham, MA is seeking a Process Development Senior Scientist who will lead late-stage drug product process characterization, support PPQ and regulatory readiness, and collaborate with cross-functional teams to optimize GMP DP processes.

You will develop stable formulations, contribute to PD workflows, author protocols and batch records, and drive continuous improvement through innovative technologies.