What are the responsibilities and job description for the Contract Analytical Research and Development Chemist position at Lupin Pharmaceuticals Inc.?
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 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.
Responsibilities
This is a Contract Position - Hired through a Third Party Agency
Role Summary
The Analytical Chemist will work with an assigned project team of chemists in the laboratory to analyze and develop HPLC and GC methods for assay, impurity, dissolution, residual solvents testing, Particle size distribution of active pharmaceutical ingredients, excipients and finished dosage forms.
Essential Duties and Responsibilities
- Perform Method Development/Method validation / stability testing, including report writing, for various dosage forms that includes Tablets, Hard Gelatin Capsules, Oral/Topical Liquids, oral suspensions, Powder for oral suspensions and Nasal products with minimum supervision
- Support the Product Development team in developing new products
- Identification and characterization of the unknown impurities in the drug products and drug substances
- Support or independently perform Method Development/Method validation / stability testing for various dosage forms that includes Tablets, Hard Gelatin Capsules, Oral/Topical Liquids, oral suspensions, Powder for oral suspensions and Nasal products
- Elemental impurity testing using ICP-MS / ICP – OES.
- Trouble shoot analytical issues to accomplish desired results
- Other duties as assigned
Qualifications
Education & Experience
- Bachelor's Degree in Chemistry, Biology, or related field, Master's Degree a plus
- 3-10 years of experience working as an R&D Chemist for a pharmaceutical company
- Operational and technical expertise in developing testing such as HPLC, GC, Dissolution, Particle size distribution, etc.
- Experience in pharmaceutical Method Development, Method Validation and stability testing.
- Capable of writing reports suitable for regulatory submission with minimum supervision.
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.
