R&D Senior Analytical Scientist - Cipla USA : Job Details

About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Job Title R&D Senior Analytical Scientist Organization Name InvaGen Pharmaceuticals Location 550 South Research Place Central Islip, NY 11722 Employment Type (Hourly/ Full Time) Full Time - Salaried/Exempt Salary Range (Base/ Hourly) $100k - $125k Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits Work Hours/ Shift/ Remote 8:30 AM - 5:00 PM Responsibilities/ Accountabilities 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.
  • Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently, develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance's and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle sizeanalyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
    • Evaluate material from new vendors for suitability of material based on physico-chemical properties and perform studies in support of vendor qualifications.
      • Conduct characterization studies and analysis of material in the laboratory.
        • 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, statistical 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
                      • Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs).
                        • Collaborate with project management (PM) function to lead execution of activities against approved plan.
                          • Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.)
                            • Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
                              • Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs)to line functions. * Independently draft and/or review standard operating procedures (SOPs).
                                • Maintain effective and pro-active communication and coordination of activities with multifunctional stakeholders.
                                  • Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j)submissions.
                                    • 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.
                                      • Train peers and junior staff members on new techniques. Typical Day-to-Day Activities
                                        New product development R&D activities such as pre-formulation, formulation, process development or analytical method development Technical Troubleshooting Technology Transfer Process Validations Method Validations New Analytical Method Development Leading activities at CROs and CMOs Drafting dossier supportive documents Drafting and responding to relevant requests from the US FDA or EU authorities Working with external partners on technical activities Education Qualifications
                                        • Minimum of a Doctorate's in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry. Experience
                                        • (3) + years of relevant industry experience. * In-depth understanding of analytical methods, theoretical principles of laboratory analytical techniques, physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
                                        • In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such as IR is a must. Experience with analytical techniques such as Dissolution, Particle Size Analysis, dynamic vapor sorption (DVS), x-ray powder diffraction (XRPD), mass spectrometry (MS), nuclear magnetic resonance (NMR) etc. is a plus. * In-depth understanding of theoretical principles of laboratory analytical techniques is a must.
                                        • Experience with extractable and leachables (E&L) studies is a big plus.
                                        • Experience with process analytical technologies (PAT) is a plus.
                                        • Must possess strong documentation and technical writing skills, and be able to apply relevant scientific principles and practices. Skills/ Competencies
                                        • Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
                                        • Strong command over written and verbal English is a must. Past publication experience is a plus.
                                        • 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.
                                        • Knowledge of statistical packages is a plus.
                                        • Must communicate clearly and concisely across levels, both orally and in written Physical Requirements
                                        • Work standing or walking unassisted for 75% or greater of an 8-hour period.
                                        • Unassisted lifting up-to 10 kg, may be required.
                                        • Able to wear appropriate personal protective equipment at all times, when required.
                                        • Sitting at a desk and/or working at a computer or other screen 75% or greater of an 8-hour period. Other Information
                                        • Relocation negotiable.
                                        • Employment sponsorship negotiable.
                                        • No remote work available.
                                        • Must be willing to work some weekends based on a relevant business need, if required. Equal Opportunity Employer Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard towithout regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected bylocal, state, or federal laws, rules, or regulations. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pre-employment Process Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing. Disclaimer on Pay Ranges About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.