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R&D Senior Analytical Scientist - Central Islip New York
Company: Cipla USA
Location: Central Islip, New York
Posted On: 11/16/2024
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
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