Analytical R and D Scientist-New Product Development

Analytical R and D Scientist-New Product Development

Analytical R&D Scientist-New Product DevelopmentTracking Code2009784Job Description
* Perform physical and chemical testing on raw materials, in-process and finished product samples. This includes documentation, report writing and review. Research, Prepare and review technical documents, including but not limited to SOP's, drug master files, vendor qualification, technical packages, compendia, protocols, raw material and intermediate specifications, test methods, certificates of analysis, method validation reports which conform to company and regulatory standards.   
* Develop, validate and transfer non-complex anto complex analytical methods.
* Prepare documents for regulatory filings (ANDA, NDA, ANDS) and internal company use. Design experiments and provide relevant data to support responses for FDA minor deficiency letters.
* Participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations.
 Required Skills
Demonstrated proficiency in a variety of analytical instruments and software utilized for physical and chemical analysis. Familiarity with a variety of compendial references including United States Pharmacopeia. The ability to develop, document and execute analyses or experiments of moderate complexity, ensuring methods are robust and reliable. The ability to maintain high quality documentation, analyze and properly interpret data, and prepare reports, SOPs or other technical reportsts is necessary. Must be able to work independently on multiple concurrent projects, develop testing plans that significantly contribute to process and material knowledge, discern specification and testing criticality and communicate effectively with cross-functional teams.
 Required Experience
These skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 5-7 years of relevant experience, or a master degree in Chemistry or Pharmaceutical Sciences combined with 1 to 2 years of relevant experience in a cGMP or cGLP LocationAllegan, MI USPosition TypeFull-Time/Regular
Position Physical Requirements
N/A