Senior Scientist - Analytical

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title: Analytical Senior Scientist

Division: Research & Development

FLSA Classification: Professional, Exempt

Work Location: Central Islip, NY

Work Hours: General Shift (8:30am-5:00pm)

Salary Range: $88,400 - $135,000

Report To: R&D Manager

Summary:

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.

JOB DESCRIPTION

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.

EDUCATION AND EXPERIENCE

• 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.
• Experience with process analytical technologies (PAT) is a plus.

PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLS

• 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.
• Knowledge of statistical packages is a plus.
• Must communicate clearly and concisely across levels, both orally and in written

OTHER JOB INFORMATION

• Relocation negotiable.
• No remote work available.
• Must be willing to work some weekends based on business need if required.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

About CiplaCipla 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.

Equal Opportunity EmployerCipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 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 reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

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.