Associate Scientist Pharmaceutical Sciences - Drug Product Development Scientist
Location: New Haven, CT (4-5 days on-site per week)
Contract Duration: 12 months
Max Pay Rate (PR): $22.75/hr.
Position Overview:
We are seeking a highly motivated individual to join our Injectable Drug Product Development team within the Pharmaceutical Development and Clinical Supply (PDCS) department. This role involves hands-on experimental work focused on drug product characterization, formulation development, process support for manufacturing, and particulates testing for intravenous and subcutaneous drug administration. The candidate will work with minimal supervision but also collaborate closely with the team, executing studies, processing data, and compiling results for development reports and other necessary documentation.
Key Responsibilities:
- Study Design & Execution:
- Design and execute development studies for clinical drug candidates and commercial products, focusing on protein drug stability (conformational and colloidal) using standard methodologies such as circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, and size-exclusion chromatography.
- Conduct physico-chemical characterization, particulates testing, and stability studies for rare disease drug candidates and commercial products.
- Assist with the preparation of internal technical reports based on executed studies.
- Participate in cross-functional development teams.
- Project Management:
- Prioritize multiple tasks and projects while working independently and as part of a collaborative team.
- Ensure adherence to timelines and project milestones.
Qualifications:
Education:
- BS or MS degree in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field.
Experience:
- 0-2 years of relevant experience in the pharmaceutical or biotechnology industry.
- Solid understanding of protein stability, thermodynamics, and protein degradation mechanisms.
- Hands-on experience with techniques such as H/UPLC, iCE/Maurice, Ion Exchange Chromatography (IEX), Micro-flow imaging (MFI), light obscuration (LO), DLS, NanoTemper, and DSC is desirable.
Skills & Abilities:
- Ability to execute experiments with minimal supervision.
- Strong interpersonal, communication, and teamwork skills.
- Proficiency with MS Office (Word, Excel, Outlook, PowerPoint).
- Comfortable working in a laboratory setting, adhering to safety guidelines, and handling biological, infectious, and hazardous materials.
Preferred Qualifications:
- Experience with sub-visible particulates characterization and testing.
- Familiarity with biophysical and analytical testing.
- Knowledge of regulatory guidelines related to drug product development.
- Experience with electronic lab notebooks (ELN), EndNote, or e-logbooks.
- Ability to take initiative and solve scientific challenges independently.
- Proficiency in maintaining laboratory instrumentation, including PMs, data backups, and software updates.
Physical Requirements:
- The role involves working in a laboratory environment. The candidate must be able to lift/carry 15-30 lbs (assisted or unassisted), gown/degown PPE, and engage in communications via phone, video, or electronic messaging. The ability to work around biological, infectious, and hazardous materials is essential.
