Principal/Fellow Scientist Jobs

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 women’s 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.

Responsibilities

Role Summary

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

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

Qualifications

Education & Experience

• PhD in Pharmaceutical Sciences or related discipline with 8+ years, MS with 12+years research experience in pharmaceutical or related field.
• Knowledge and in-depth understanding of global regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
• Must possess expert knowledge in characterization of pressurized Metered Dose Inhaler (pMDI) and DPI products.
• Excellent understanding of USP methodologies and ICH guidelines. Deep k nowledge of the FDA cGMP requirements as they apply to the Pharmaceutical industry.
• Extensive knowledge of aerosol characterization methodologies (Cascade Impaction, Laser Diffraction techniques etc.) and analytical chemistry methodologies (UPLC/HPLC, GC, UV, FTIR etc.).
• 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.

COVID19 Vaccination Requirements

If you are hired, Lupin will require you to prove that you are fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from becoming vaccinated. As an employee, you will be required to follow Lupin policies related to any additional or future COVID-19 vaccination or booster shot requirements.