Principal Scientist - Formulation

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Job Description

Independently designs and conducts experiments including preformulation, formulation and process development studies for pressurized metered dose inhaler (pMDIs) and dry powder inhaler (DPI) products. Leads and supervises standard and advanced laboratory activities including characterization studies for pMDI and DPI products. Conduct evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.) for inhalation product development. Leads and supports the development and evaluation of new formulation technologies where required. Adherence and following cGMP, Lupin EH&S and other relevant guidelines. Initiates and leading investigations, perform data reviews, contributes to planning of product development resources, and coaches and trains junior scientific members.

Essential Duties and Responsibilities

• Independently designs and conducts experiments including preformulation, formulation and process development studies for pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI) products.
• Develop statistical design of experiments independently. Regularly analyze data, perform statistical analysis,  identify trends and interpret data. Present data, recommendations and conclusions to senior management on a regular basis.
• Lead characterization studies for evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material).
• Execute and supervises standard and advanced laboratory activities including characterization studies for pMDI and DPI products.
• Execute and lead manufacturing process development including clinical trial and exhibit batch manufacturing.
• Write protocols, methods, reports, standard operation procedures, batch manufacturing records, and regulatory submission documents to support submission and product approval when required.
• Troubleshoot technical issues, identify solutions, and implement recommendations. Leading investigations, manage and complete Quality Events, Change Controls and CAPA on schedule.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Act as subject matter expert (SME) in formulation and process development, and on aerosol characterization methodologies for orally inhaled and nasal products (OINDPs).
• Execute and supervise the execution of technical / scientific activities required for regulatory submission including process transfer protocols and process validation. Participate in laboratory activities as required.
• Represent CMC on project teams.
• Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Work and communicate effectively with team members, with other functional groups and across global respiratory R&D sites, and external customers.
• Plan laboratory activities and ensuring project timelines are met.
• Establish and maintain effective relationships with team members.
• Conduct laboratory and development work in accordance with SOPs; follow Lupin safety rules and procedures.
• Comply with cGMP, EH&S, Lupin Corporate guidelines and policies, FDA and other governing bodies.

Qualification and Experience

• PhD in Pharmaceutical Sciences/Pharmaceutical Technology/Pharmaceutical Chemistry/Chemical Engineering or related discipline with a minimum 8 years of relevant experience, Minimum 12 years experience in pharmaceutical technology or related field with MS or without a PhD. 
• In-depth knowledge in characterization / formulation and process development of pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI) products.
• In-depth knowledge of aerosol and material characterization methodologies (Laser diffraction techniques, particle size distribution, etc) and knowledge analytical chemistry methodologies will be useful.
• Knowledge and understanding of regulatory requirements as applied to orally inhaled and nasal products (OINDPs).
• In depth knowledge and understanding of USP methodologies ICH guidelines, 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.

Competencies