Inhalation Chemist

JOB DESCRIPTION

The R&D Inhalation Chemist position is an individual contributor role and hands-on role 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:

• Possess good understanding of the analytical techniques for inhalation products like metered dose inhaler (MDI) and dry powder inhaler (DPI) etc.
• Operate as the subject matter expert (SME) on analytical methods for inhalation products that are under development and site transfer or products that are commercialized.
• Operate as the subject matter expert (SME) on inhalational 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.
• Conduct preformulation studies for orally inhaled drug products following regulatory guidelines, industry best practices, US FDA cGMPs.
• Perform analytical techniques like APSD using ACI/NGI, DUSA, Particulate matter, Spray pattern, Plum geometry, HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS.
• 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.
• 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

• Support new product development analytical activities pertaining to the inhalation products
• R&D activities such as pre-formulation 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 AND EXPERIENCE

• Doctorate in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
• Masters in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry with 5+ years of relevant industry experience with inhalation products
• In-depth understanding of inhalation 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 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

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