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

• Hands-on experience in:
• Preclinical formulation and pre-formulation characterization
• Drug product formulation and process development (QbD)
• Tech transfer and cGMP manufacturing support
• Experience developing phase-appropriate drug product and supporting clinical supply manufacturing for small molecules and/or oligonucleotides.
• Experience working with and coordinating activities across external CROs and CDMOs/CMOs.
• Familiarity with ICH quality guidelines and FDA/EU drug manufacturing regulations.
• Ability to review and approve GxP documentation and technical reports.
• Strong written and verbal communication skills, including technical presentations to scientific and cross-functional audiences.
• Ability to work effectively in cross-functional and matrixed team environments.

Nice to Have

• Experience with oligonucleotide formulation and process development.
• Exposure to injectable peptides or advanced modalities.
• Prior experience contributing to publications or external scientific presentations.

Education

• Master’s degree in Chemistry, Chemical Engineering, or Pharmaceutical Sciences with 8–10 years of relevant industry experience

OR

• PhD in a related discipline with 5–7 years of relevant industry experience in drug product development