Senior Manager / Principal Scientist - CMC Drug Product Development

Role Overview

This role supports drug product development activities across early and clinical-stage programs, with primary responsibility for formulation development, clinical manufacturing support, and technology transfer. The position works closely with internal CMC teams and external partners to ensure high-quality, phase-appropriate drug product delivery in compliance with GxP and regulatory requirements.

The role is hands-on and execution-focused, contributing technical expertise across small molecule programs with exposure to oligonucleotides and advanced modalities

Key Responsibilities

• Support delivery of drug product development activities , including :
• Pre-formulation and formulation development
• Process development and tech transfer
• Phase-appropriate stability studies
• GMP clinical trial material (CTM) manufacturing
• Contribute to drug substance / drug product supply activities , including preparation and review of GxP documentation and technical summaries.
• Support regulatory document authoring and review (e.g., IND, IMPD, NDA sections) and assist in responses to health authority questions.
• Collaborate with external CROs, CMOs, and CDMOs on formulation development, manufacturing execution, and technology transfer.
• Review and approve technical reports, manufacturing documentation, and development data for accuracy and compliance.
• Work cross-functionally with CMC, Quality, Regulatory, and Development teams to support program execution.
• Ensure compliance with applicable GMP, GLP (as applicable), safety, quality, and corporate policies
• Present scientific data internally and contribute to technical discussions and decision-making.

Required Experience & Skills

Nice to Have

Education

OR