Scientist I

Overview

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 Fifteen 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

Conduct material characterization, formulation and process development of solutions, suspensions, propellant based and powder formulations for orally inhaled products following cGMP, EH&S and relevant guidelines.

Essential Duties and Responsibilities

• Set up and operate formulation and testing instrument, and manufacturing and packaging process equipment. Conduct instrument and process troubleshooting.
• Prepare and maintain accurate records in lab notebooks and batch records of all testing or activities performed. Analyze data, identify trends and perform statistical analysis.
• Write protocols, methods, standard operation procedures, and contribute to submission documents independently. Design experimental studies and write reports with minimal supervision.
• 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. Lead broad project tasks effectively, with minimal supervision.
• Design studies and conduct evaluation and selection of raw material (APIs, excipients, primary and secondary packaging material, device component material etc.).
• Design studies and conduct formulation development studies for solutions, suspensions, emulsions, bulk and formulated powders, propellant driven formulations for orally inhaled products.
• Design process development studies and conduct evaluation and optimization of manufacturing and packaging process for orally inhaled products.
• Execute formulation and manufacturing activities including powder blending and canister filling, and troubleshoot technical issues during manufacture of Dry Powder Inhaler (DPI) and Metered Dose Inhaler (MDI) drug products.
• Support the evaluation and introduction of new technologies; be capable of generating new practical ideas; possess good understanding of process technologies and experimental design.
• Conduct lab work in accordance with SOPs; assure compliance to Lupin Quality procedures and follow Lupin safety rules and procedures. Comply with all Lupin Corporate guidelines and policies.

Qualifications

Education & Experience

• PhD in Pharmaceutics / Pharmacy / Process, Chemical or Mechanical Engineering or related discipline with 2 years, MS with 5 years, or BS with a minimum of 10 years pre-formulation, formulation, process and product development experience in the pharmaceutical or related fields. 
• Have hands-on experience with typical formulation, characterization and processing equipment for metered dose inhaler / dry powder inhaler / nasal products, or some specialized knowledge of any of these topics.
• Knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Excellent understanding of USP methodologies and ICH guidelines.
• Strong English language skills including writing ability and oral communication.

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.

Lupin  is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

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 an office environment.

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Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails