Job Description
Scientist, Analytical R&D - Allegan MI Kelly Science & Clinical is looking to fill a Scientist, Analytical R&D position in Allegan, MI! The contract is slated to last 4+ years with the possibility to be extended, and the need to fill is immediate. Day to Day Responsibilities: - Research, prepare and review technical documents, including but not limited to SOP's, drug master files, vendor qualification, technical packages, compendia, protocols, raw material specifications, test methods, certificates of analysis, analytical reports, and method validation reports which conform to company and regulatory standards.
- Perform physical and chemical testing on active pharmaceutical ingredients and excipients. This includes documentation, report writing and review.
- Develop, validate, and transfer non-complex and 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.
Qualifications: - Bachelor’s degree or higher in Chemistry or Pharmaceutical Sciences combined with at least 5 years of relevant experience in a cGMP or cGLP laboratory.
- Demonstrated proficiency in a variety of analytical instruments and software utilized for physical and chemical analysis.
- Experience in raw material analysis (e.g., residual solvents, particle size, related substances) and familiarity with DMFs preferred.
- 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 reports is necessary.
- Technical writing and data analysis skills highly desired.
- 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.
- These skills are normally acquired through completion of a bachelor’s degree in Chemistry or Pharmaceutical Sciences combined with relevant experience in a cGMP or cGLP laboratory.
Pay: $80-100K/yr and based on experience Benefits: This position comes with a comprehensive benefits package Hours: 8AM – 5PMEST, M-F For more information or to be considered, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745. 9431508
Job Tags
Full time, Contract work, Immediate start,