Senior Formulation Scientist
About The Position
The Senior Formulation Scientist independently conducts standard and advanced laboratory activities, including evaluation and selection of raw materials such as APIs, excipients, packaging materials, and device components. The role performs pre-formulation and formulation development for solutions, suspensions, emulsions, bulk and formulated powders, and propellant-based formulations for orally inhaled products, in accordance with cGMP, Lupin EH&S, and other applicable guidelines. The scientist also develops and evaluates new formulation technologies where required. The position involves designing and conducting studies, operating and troubleshooting laboratory equipment, analyzing and documenting data, preparing protocols and technical documents, and contributing to project work with minimal supervision. It supports manufacturing and technical troubleshooting for DPI, MDI, and nebulizer drug products, investigates deviations and atypical results, and helps introduce new technologies. The role also coaches and trains junior laboratory staff and ensures compliance with quality procedures, SOPs, safety rules, and corporate policies.
Requirements
- PhD in Pharmaceutics, Pharmaceutical Chemistry, Analytical Chemistry, or a related discipline, with 5 or more years of pre-formulation and formulation research experience in the pharmaceutical field; or an MS with 10 or more years; or a BS with at least 15 years.
- Hands-on experience with typical formulation and processing equipment.
- Knowledge and understanding of FDA cGMP requirements as they apply to the pharmaceutical industry.
- Excellent understanding of USP methodologies and ICH guidelines.
- Strong English-language skills, including writing and oral communication.
Nice To Haves
- Experience with pre-formulation and formulation research.
Responsibilities
- Independently set up and operate laboratory equipment and troubleshoot instruments.
- Prepare and maintain accurate laboratory notebook records; analyze data, identify trends, and perform statistical analysis.
- Write protocols, methods, standard operating procedures, and submission documents; design experimental studies and prepare reports with minimal supervision.
- Participate in project activities, support project timelines, contribute to team objectives, communicate with team members and customers, and coordinate effectively with other functional groups.
- Lead broad project tasks with minimal supervision.
- Design and conduct studies to evaluate and select raw materials, including APIs, excipients, primary and secondary packaging materials, and device component materials.
- Design and conduct pre-formulation and formulation development studies for solutions, suspensions, emulsions, bulk and formulated powders, and propellant-driven MDI formulations.
- Support manufacturing activities, including powder blending, and troubleshoot technical issues involving DPI, MDI, and nebulizer drug products.
- Investigate deviations, out-of-specification results, and out-of-trend results, and recommend corrective actions.
- Support evaluation and introduction of new technologies and generate practical ideas based on knowledge of process technologies and experimental design.
- Coach, train, and support junior laboratory staff and maintain effective relationships with team members.
- Conduct laboratory work in accordance with SOPs, Lupin quality procedures, safety rules, and corporate guidelines and policies.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
