Senior Scientist - Analytical Chemistry

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SCOPE

The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job.  This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications.  The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations. 

PURPOSE

The R&D Senior Scientist Analytical Chemistry position is an individual contributor role and reporting to a Manager of Research & Development (R&D) at 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.
• 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 size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
• Lead and define strategy on all topics extractable and leachables (E&L).
• 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, 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 multi-functional 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.
• 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 ACTIVIES 

• 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