Job 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.
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/ |
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.
Skills
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder