CMC Scientist – Parenteral Drug Product Development

About the role

We are seeking a CMC Scientist to support parenteral drug product development with a focus on in-use compatibility and stability studies, manufacturing support, and technical documentation. This role will collaborate with formulation, analytical, manufacturing, quality, and clinical teams to support mid- and late-stage development programs.

Responsibilities

• Design and execute in-use compatibility and stability studies for injectable drug products.
• Perform analytical testing (MFI, SEC, pH, osmolality, protein concentration, particulates) and analyze results.
• Author study protocols, reports, and technical documentation to support regulatory submissions.
• Support drug product manufacturing activities including compounding, filtration, filling, and lyophilization.
• Coordinate sample management, stability testing, and laboratory activities.
• Maintain inspection-ready documentation in electronic document management systems.
• Ensure compliance with GMP, GDP, ICH guidelines, and data integrity requirements.

Qualifications

• Bachelor's with 6+ years, Master's with 4+ years, or Ph.D. with 0–2 years of pharmaceutical/biopharmaceutical experience.
• Experience in parenteral/sterile drug product development.
• Hands-on experience with compatibility, stability, or in-use studies.
• Knowledge of sterile manufacturing processes and analytical techniques.
• Experience with Veeva, Documentum, or similar document management systems.
• Strong technical writing, documentation, and cross-functional collaboration skills.

Location: Lexington, MA
Duration: 12+ months contract
Work Type: Onsite