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.

- 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 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.

- 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

Preferred and Required Education & Experience :

- Doctorate in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with three (3) plus years of relevant experience.

- Masters in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with five (5)+ 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 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.

- 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:

- Relocation negotiable.

- Employment sponsorship negotiable.

- No remote work available.

- Must be willing to work some weekends based on business need if required

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