CMC Scientist

Position Title: CMC Scientist Work Location: Lexington, MA 02421Assignment Duration: 16 MonthsWork 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.Applicant Notices & DisclaimersFor information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws