Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on womens health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Independently designs, conducts, leads and supervises standard and advanced laboratory activities including characterization studies for pressurized Metered Dose Inhalers (pMDIs) and Dry Powder Inhaler (DPI) products. Supports evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); analytical development studies for pMDIs and DPIs following cGMP, Lupin EH&S and other relevant guidelines. Leads and supports the development and evaluation of new analytical technologies where required. Initiates investigations and data reviews, contributes to planning of analytical resources, and coaches and trains junior scientific staff.

Essential Duties and Responsibilities

• Independently design, conduct, lead and supervise characterization studies for pMDIs and DPI products.
• Provide leadership in CMC activities and represent CMC on global project teams.
• Act as subject matter expert (SME) on aerosol analytical characterization methodologies for orally inhaled and nasal products (OINDPs).
• Lead characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); analytical development studies for pMDIs and DPIs following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
• Supervise and lead the execution of analytical activities required for regulatory submission including method transfer protocols and validation of analytical methods. Participate in laboratory activities as required.
• Write protocols, methods, reports, standard operation procedures, and submission documents when required.
• Analyze data, identify trends and perform statistical analysis. Present data, recommendations and conclusions to senior management on a regular basis.
• Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Develop statistical design of experiments with minimal supervision.
• Write regulatory submission modules and any other documents to support submission and product approval.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives.
• Communicate effectively with team members and internal or external customers.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Independently lead major project tasks.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Lupin safety rules and procedures.
• Comply with all Lupin Corporate guidelines and policies.

Education & Experience

• PhD in Pharmaceutical Sciences or related discipline with 8 years, MS with 12 years research experience in pharmaceutical or related field.
• Must possess expert knowledge in characterization of pressurized Metered Dose Inhaler (pMDI) and DPI products.
• Knowledge and in-depth understanding of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
• Extensive knowledge of aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.) and analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.).
• Excellent understanding of USP methodologies and ICH guidelines. Deep knowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
• Strong English language skills including writing ability and oral communication. Experience with writing of CMC sections of regulatory documents (NDA, ANDA, IND, IMPD).

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in a laboratory environment.

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