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.

This is a Contract Position - Hired through a Third Party Agency

Role Summary

Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment.

Essential Duties and Responsibilities

• Review Literature and gather patent and published articles on the selected projects.
• Analyze and interpret results in written and oral format in consultation with Product Development Management.
• Determine best possible strategy for formulating assigned projects and meet regulatory criteria.  
• Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms.
• Perform formulation experiments to develop ANDA or NDA submission batches.
• Responsible for CMC documentation, project documentation and for preparing necessary technical reports.  
• Perform all the processing steps such as weighing, blending, milling, compression etc.
• Directs the work and schedules of technicians and provides technical assistance to associates and other formulation scientists.
• Maintain accurate lab notebooks and complete all related development reports, in compliance with departmental needs and SOPs.
• Technical responsibility for interpreting, organizing, executing and coordinating assignments and assigned development projects.
• Maintains liaison with individuals and units within or outside of the organization as directed by Product Development Management.
• Plans, organizes and supervises the assigned work staff of associates and technicians. 
• Responsible for project management of assigned product development projects.
• Responsible for the production of clinical supplies
• Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with the manufacturing department as needed.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices.

Education & Experience

• Master’s degree (or higher) in a pharmaceutical science field preferred.
• Minimum 4 years of experience in pharmaceutical drug product development, preferably in generic pharmaceuticals
• Technical expertise necessary to design pharmaceutical products and manufacturing processes.
• Proven ability to supervise technical and operational personnel.
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Physical Requirements

This position may require lifting up to 20 pounds occasionally. Generally work is performed in a laboratory environment with chemicals, reagents and solvents.