Scientist I

Lupin Pharmaceuticals•Coral Springs, FL

41d

About The Position

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.

Requirements

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 .

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