We have been engaged to find an experienced Scientist with a proven background in the development of analytical methods for pharmaceutical or biological drug-based products. Excellent opportunity to make an immediate impact with great company. . .put your skills in chemistry, pharmaceuticals, and scientific analysis to work in a new role today!
Responsibilities include:
• Responsible for analysis and validation of all raw materials, in-process materials, final product and stability studies
• Development and validation (method development and validation) of analytical methods and assays to support the drug development, product development, product characterization, product pipeline and commercialization of all products produced
• Develop and write SOPs
• Provide technical support and subject matter expertise, both internal and external
• Work with new drug product and/or drug containing products and combined therapies
• Responsible for writing scientific reports, papers and technical documents as well as supporting various regulatory filings for new products
• Will work with established QA Team to ensure all procedures are completed and documented to internal company standards and that all 3rd party labs and vendors meet quality compliance
The qualified candidate will have:
• Proven, hands on skills with HPLC, MS, GC, LC/MS, FTIR, UV-VIS
• Ability to develop, implement and troubleshoot analytical methods
• Experience working with R&D and clinical research material / products
• 5+ years of analytical work and scientific analysis, or pharmaceutical or drug-products or drug-containing development work, can include time in post-doc work
• Strong verbal, written communication and organizational skills
• Capable of managing a laboratory staff, deadlines and a budget
• Knowledge of and training in GLP, GMP, and USP guidelines and regulations
• MS in Chemistry, PhD in Chemistry, Biochemistry or other area of scientific study is a plus
Industry: Chemistry, R&D, Pharmaceutical, Biotechnology, Combination Products, Analytical Chemistry, HPLC, GLP