What are the responsibilities and job description for the CMC Scientist – Parenteral Drug Product Development position at QvalFocus Inc.?
- CMC Scientist Parenteral Drug Product Development Location: Lexington, MA Duration: 12 Months Contract Work Type: Onsite
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.
Key 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.
- 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