Job Title: Associate Scientist
Location: Summit - West, New Jersey, USA
Type: Contract (6 Months, with strong possibility of extension)
Positions Open: 2
Schedule: 40 hours/week, Monday to Friday, 8-hour shifts
Work Arrangement: 100% Onsite
Job Description:
We are seeking a highly motivated Associate Scientist to join the Microscopy and Spectroscopy Lab (MSL) within the Manufacturing Sciences and Technology (MS&T) team. This role focuses on physical and chemical characterization and forensic investigation of materials such as unknown components or foreign matter in cell therapy manufacturing processes.
Key Responsibilities:
- Conduct microanalytical investigations related to unknown components or foreign matter in reagents, raw materials, single-use consumables, process intermediates, and final drug products.
- Perform hands-on analysis using advanced analytical instruments including FT-IR, confocal Raman, SEM/EDX, UV-Vis, and NIR.
- Apply spectroscopic and microscopic techniques to support product and process investigations.
- Write comprehensive technical reports and maintain accurate experimental records.
- Support daily lab operations, including sample analysis request distribution and lab supply management.
- Collaborate across functional teams to support manufacturing, analytical, and quality groups.
- Ensure lab operations comply with cGMP regulations and safety protocols.
- Assist with troubleshooting and perform analytical testing for manufacturing issues.
Required Qualifications:
- Bachelor's degree (required) or Master's degree (preferred) in Forensic Science, Biology, Biochemistry, or a related field.
- 1-3 years of hands-on experience using microscopy and spectroscopy techniques in a pharmaceutical/biotech environment.
- Experience with SEM/EDX, FTIR, Raman, UV/Vis, and NIR.
- Demonstrated proficiency with scientific software for spectral analysis and Microsoft Office Suite.
- Working knowledge of cGMP, FDA regulations, and quality documentation standards.
- Excellent analytical, troubleshooting, and documentation skills.
Preferred Skills:
- Knowledge of protein/cell chemistry related to structure and function.
- Familiarity with particulate and foreign matter investigations.
- Experience with mass spectrometry, particle sizing, and hypercube spectral imaging.
- Background in forensic investigational work.
- Experience with automation and laboratory instrumentation software.