Highlights
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. 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.
Numbers & Facts
| Location | Lexington, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $70 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Objective:
The Contract 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. The successful candidate will work cross-functionally with formulation, analytical, manufacturing, quality, and clinical operations teams to advance drug product deliverables.
Accountabilities:
- 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.
EDUCATION, EXPERIENCE AND SKILLS:
(List the education and experience required to perform the primary responsibilities of the job. Equivalent combinations of education and experience should be noted).
Education and 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.
Knowledge and Skills:
- 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).
Physical Demands:
- (Identify any physical demands required in the performance of the primary responsibilities of the position).
- Need to be able to carry out in-use compatibility studies and test samples with minimal sitting for several hours.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.