Cipla USA · 18 hours ago
Senior Scientist - Analytical
Central Islip, NY
Full-time
Onsite
Mid, Senior Level
$88K/yr - $135K/yr
5+ years expCipla (InvaGen) Pharmaceuticals Inc. is looking for an Analytical Senior Scientist position in Research & Development at our US facility in Central Islip, New York. The Analytical Senior Scientist position is an individual contributor role focused on developing and validating analytical test methods for pharmaceutical products, while supporting product development activities and ensuring compliance with regulatory standards.
Pharmaceuticals
Responsibilities
Operate as the subject matter expert (SME) on analytical methods for products that are under development, products that are commercialized and in support of process analytical technologies (PAT) for commercial manufacturing processes
Independently develop and validate analytical test methods for active pharmaceutical ingredients (APIs), excipients and drug products using several analytical techniques such as HPLC, UPLC, GC, LC-MS, SEC/MALS, HPLC/ELSD, HR-MS, CD, DVS, DSC, XRPD, TGA, Viscometer, Karl-Fisher, IR, Particle size analyses etc., following United States Pharmacopoeia (USP)/ International Council for Harmonization (ICH) guidelines
Evaluate material from new vendors for suitability of material based on physico-chemical properties and perform studies in support of vendor qualifications
Lead drafting of product specifications and analytical procedures
Lead analysis of samples for various R&D and GMP stability studies
Support Product Development activities by analyzing the samples at different stages of pre-formulation, formulation and process development
Implement new analytical techniques that are not currently utilized at the site
Conduct trend analysis of data including kinetic modeling, stastical analysis etc
Draft high-quality documents in support of dossiers (protocols, reports, technical memos)
Lead investigation for quality events (planned and unplanned deviations) with appropriate justifications
Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers
Write reports for US FDA submissions such as a Quality Overall Summary
Operate as Analytical single point contact on various project teams
Train peers and junior staff members on new techniques
Qualification
Required
Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with 5+ years of experience in Sterile complex injectables/Oral Solids dosage forms
Master's degree with 10+ years of experience in Sterile complex injectables/Oral Solids dosage forms
In-depth understanding of analytical methods, theoretical principles of laboratory analytical techniques, physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must preferable in Injectables and/or solid oral dosage forms
In-depth understanding of various pre-formulation and formulation studies including excipient compatibility, forced degradation studies and analysis of stability data is a must
In depth understanding of HPLC, UPLC, GC, LC-MS, SEC/MALS, HPLC/ELSD, HR-MS, CD, DVS, DSC, XRPD, TGA, Viscometer, Karl-Fisher, IR, Particle size analyses is a must
Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices
Strong command over written and verbal English is a must
Must be able to work under minimal supervision and able to work independently and in a team environment
Must be able to exercise appropriate professional judgment on matters of significance
Must be proficient in computer skills and software applications such as Microsoft Office tools
Must communicate clearly and concisely across levels, both orally and in written
Preferred
Experience with process analytical technologies (PAT) is a plus
Knowledge of statistical packages is a plus
Benefits
Benefits
Participation in a bonus program based on performance and company results
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Arunesh Verma
President & CEO, Cipla North America
Marc Falkin
Executive Vice President / Chief Commercial Officer
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