CMC Scientist

Position Title: CMC Scientist

Work Location: Lexington, MA 02421

Assignment Duration: 16 Months

Work Arrangement: Onsite at least 4 days/week

Position Summary:

• The Scientist will support parenteral drug product development activities with a focus on hands-on in-use compatibility and stability studies, oversight support of drug product manufacturing, and management of technical documentation.
• The role is intended to provide dedicated technical and operational capacity across mid-stage and late-stage development programs, ensuring studies are executed on schedule, manufacturing activities are appropriately supported, and program documentation is complete and accurate.

Background & Context:

• The successful candidate will work cross-functionally with formulation, analytical, manufacturing, quality, and clinical operations teams to advance drug product deliverables.

Key Responsibilities:

• Design and execute in-use studies for parenteral (injectable/infusion) drug products, including dose preparation, dilution, compatibility, hold-time, filter and infusion-set compatibility, and simulated clinical-administration assessments.
• Test in-use study samples using relevant physicochemical and analytical methods, including micro-flow imaging (MFI) for subvisible particles, pH, osmolality, protein concentration, and size-exclusion chromatography (SEC); generate, review, and trend the resulting data.
• Author study protocols, plans, and reports for in-use and related drug product studies (potentially including formulation and process development studies); interpret analytical results and summarize conclusions to support clinical use instructions and regulatory filings.
• Coordinate and support sample management and testing logistics with analytical and quality laboratories, including stability pull schedules and data tracking.
• Organize, review, and maintain electronic technical documentation, ensuring documents are current, accurately versioned, appropriately filed in electronic document management and data systems, and inspection-ready.
• Ensure all work is performed in compliance with applicable GMP, GDP, safety, and data-integrity requirements, as well as internal procedures and quality standards.
• Present study updates and findings to project teams and contribute to cross-functional development discussions.

Qualification & Experience:

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Biology, or a related scientific discipline with 6 years of relevant pharmaceutical/biopharmaceutical industry experience; OR Master's degree with 4 years; OR Ph.D. with 0–2 years of relevant experience.
• Demonstrated experience in parenteral / sterile drug product development, formulation, or manufacturing support.
• Hands-on experience with in-use, compatibility, and/or stability studies for injectable or infusion products strongly preferred.
• Working knowledge of drug product manufacturing operations (e.g., compounding, filtration, filling, lyophilization) in a development or GMP environment.
• Experience authoring technical documents (protocols, reports, batch records) and working within electronic document management systems (e.g., Veeva, Documentum, or equivalent).
• Familiarity with GMP, GDP, ICH, and data-integrity expectations in a regulated environment.
• Strong technical understanding of parenteral drug product formulation, physicochemical stability, and compatibility principles.
• Solid laboratory skills and familiarity with analytical techniques used to characterize protein/biologic or small-molecule drug products (e.g., appearance, particulates, concentration, aggregation, pH, osmolality).
• Excellent scientific/technical writing skills, with the ability to produce clear, accurate, and well-organized protocols and reports.
• Strong organizational and documentation-management skills, with meticulous attention to detail and version control.
• Effective cross-functional collaboration and communication, able to interface with formulation, manufacturing, analytical, and quality partners.
• Comfortable working on-site in laboratory and adhering to associated gowning and safety requirements.
• Proficiency with standard productivity and data tools (e.g., Microsoft Office; electronic lab notebook and document systems).

Working Conditions & Physical Demands:

• Need to be able to carry out in-use compatibility studies and test samples with minimal sitting for several hours.

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