ALL APPLICANTS MUST SUBMIT A RESUME IN MICROSOFT WORD OR ADOBE PDF FORMAT.
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.
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
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 AND EXPERIENCE
Doctorate in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
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 that 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 big plus.
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. 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.
OTHER JOB INFORMATION
Employment sponsorship negotiable.
No remote work available.
Must be willing to work some weekends based on business need if required.
Additional Salary Information: Variable Pay Performance Bonus Target of 10%.
Internal Number: RDSRSCIANCHEM06042020
About InvaGen Pharmaceuticals, Inc., a Cipla subsidiary
InvaGen Pharmaceuticals, Inc. is 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 Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. The company is also referred to as Cipla New York.
The Cipla New York site consists of three manufacturing facilities and a diverse workforce performing a variety of roles such as senior scientist, quality control chemist, quality assurance associate, regulatory affairs analyst, manufacturing and production operators, and other business and technical positions.