Senior Manager, Formulation and Drug Product Development

Role Summary

Senior Manager, Formulation and Drug Product Development will drive CMC development activities and manage cross-functional projects as part of the Drug Product Development team in Lexington, MA. Reporting to the Director, Formulation and Drug Product Development, this role supports drug product development programs and pipeline initiatives. The position is based in Lexington, MA with a hybrid schedule (4 days in the office, 1 day remote).

Responsibilities

• Lead product candidates’ manufacturability/developability assessment and collaborate with Discovery team on drug candidate selection
• Establish formulation screening strategies for high concentration biologics in a dynamic environment
• Develop, manage, execute, and support clinical in-use studies and other dose administration related studies to support tox and clinical studies
• Contribute to the evaluation and selection of CRO and CDMO for development studies and GMP manufacturing
• Manage external partners (CRO/CDMO) to advance project milestones
• Support process development studies and DP manufacturing tech transfer
• Author and review study protocols and reports, summarize and communicate project updates to stakeholders

Qualifications

• PhD or MSc with 4+ years of experience in protein chemistry and formulation science, particularly involving parenteral formulations
• Previous experience with biologics (such as monoclonal antibody, fusion protein, antibody drug conjugates) required
• Strong problem-solving skills and excellent communication abilities
• Ability to manage multiple priorities and work with ambiguity
• Strong commitment to compliance and ethical standards
• Ability to travel up to 5%