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

Conducts routine and non-routine laboratory activities following with minimal supervision. Assures that quality standards are met. Prepares protocols and reports and documents activities following cGMP rules. 

Essential Duties and Responsibilities

• Conduct standard and advanced laboratory activities with minimal supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
• Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results.
• Execute approved method transfer protocols, develop and validate cleaning validation methods
• Prepare and maintain accurate records in lab notebooks of all testing performed. Analyze data, identify trends and perform basic statistical calculations
• Write protocols, reports, methods, standard operation procedures, and submission documents with supervision
• Conduct manufacturing activities for MDI/DPI/Nasal drug products with limited supervision.
• Support the evaluation and introduction of new technologies
• Independently train other scientists
• 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 effectively with other functional groups. Lead small project tasks effectively, with some supervision.
• Establish and maintain effective relationships with team members.
• Conduct lab work in accordance with SOPs; follow Corporate safety rules and procedures.

Comply with all Corporate guidelines and policies

Qualifications

Education & Experience

• PhD in analytical chemistry or related discipline with 0-2 years, MS in Chemistry with 3-5 years, or BS with a minimum of 7 years analytical research experience in pharmaceutical or related field. 
• Must possess broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies and/or basic knowledge of development and manufacturing MDI/DPI/Nasal products.
• knowledge and understanding of the FDA cGMP requirements as they apply to the Pharmaceutical industry. Good understanding of USP methodologies and ICH guidelines
• Strong English language skills including writing ability and oral communication.

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.

Search Firm Representatives Please Read Carefully 

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