Senior Scientist - Analytical

Cipla•Central Islip, NY

19h•Onsite

About The Position

Cipla (InvaGen) Pharmaceuticals Inc. is looking for an Analytical Senior Scientist position in Research & Development at our US facility in Central Islip, New York. Cipla Pharmaceuticals is a Generic Business focused on products in a wide range of therapeutic interests. The Analytical Senior Scientist position is an individual contributor role and hands-on role reporting to a Senior Manager of Research & Development (R&D) at InvaGen/Cipla New York. If you are an individual with domain expertise who enjoys working in a laboratory with various analytical instruments, this position will be a perfect fit for the joy of work. Cipla (InvaGen) Pharmaceuticals offers an opportunity to work in Generic Products business. This role is a unique opportunity to build a business with the backing of a 90-year-old plus a legacy of sophisticated expertise in dosage forms, CMC, large scale manufacturing, and drug discovery. Cipla has a proven performance track record in 80 countries with over 1000+ products across various therapeutic categories. The Analytical Senior Scientist position is an individual contributor role and reports to the Manager of Analytical Research & Development (AR&D) for InvaGen/Cipla New York. The job duties for this position include but are not limited to the following: 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.

Requirements

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.

Nice To Haves

Experience with process analytical technologies (PAT) is a plus.
Knowledge of statistical packages is a plus.

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.