Job Title: Research Scientist
Location: Onsite, Cranbury NJ
Position Type: Full-Time
Reports To: Director, Analytical R&D/QC
Job Summary:
We are seeking a highly motivated Research Scientist to join our Analytical R&D and QC department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a strong background in analytical chemistry and experience in method development, validation, and quality control testing.
Key Responsibilities:
- Conduct analytical method development and validation independently.
- Troubleshoot analytical methods as needed and gain more experience in the related area.
- Conduct release testing for GMP regulatory starting materials, intermediates, and final APIs.
- Conduct testing for stability studies and cleaning verification.
- Review test data to ensure completion and accuracy.
- Write raw material test procedures as needed under supervision.
- Write SOPs and protocols as needed under supervision.
- Write instrument operating, maintenance, and qualification/calibration procedures as needed.
- Participate in OOS and deviation investigations, as needed.
- Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC/AD.
- Troubleshoot and maintain analytical instruments. Ensure that instrument calibration and qualification intervals are current.
Qualifications:
- BS, MS, or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related field.
- 3+ years of experience in analytical R&D and/or QC within the pharmaceutical or CDMO industry.
- Strong knowledge of analytical techniques, including HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
- Familiarity with method validation protocols and regulatory requirements.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Proficient in data analysis software and laboratory information management systems (LIMS).