Porton Pharma Solutions Ltd. · 1 week ago
Analytical/QC Research Scientist （Drug Product/Drug Substance)
Cranbury, NJ
Full-time
Onsite
Mid Level
3+ years expPorton Pharma Solutions Ltd. is seeking a highly motivated Research Scientist to join their Analytical R&D and QC department within the CDMO industry. The ideal candidate will have a strong background in analytical chemistry and will be responsible for conducting analytical method development, validation, and quality control testing.
Pharmaceuticals
Hiring Manager
孙于文
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
Perform structural elucidation of small molecule drug substances, intermediates, and starting materials
Independently troubleshoot and resolve issues with NMR instrumentation
Provide clear oral and written explanations of NMR data for structural elucidation
Identify and elucidate the structures of related impurities and degradants from API synthesis, fate and purge, and stress degradation studies
Qualification
Required
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)
Company
Porton Pharma Solutions Ltd.
With over 4,200 employees and 18 operations and commercial offices across the US, EU, and China, Porton Pharma Solutions provides global pharmaceutical and biotech companies with innovative, reliable, and end-to-end process R&D and GMP manufacturing services across Small Molecules, Tides, Biologics and Conjugates (ADCs, AOCs, PDCs, RDCs, etc.), as well as Advanced Therapy Medicinal Products.
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase