What are the responsibilities and job description for the Analytical / QC Research Scientist (DS / DP) position at Porton Pharma Solutions Ltd.?
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 :
