R&D Senior Analytical Scientist

Cipla • Central Islip, NY

244d • $100,000 - $124,000

About The Position

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. 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.

Requirements

• Minimum of a Doctorate’s in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
• 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.
• In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such as IR.
• 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.
• 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.

Nice To Haves

• Past publication experience 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, 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.
• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Ph.D. or professional degree