The Senior Analytical Chemist performs routine and non-routine GLP and GMP analytical testing in support of pharmaceutical and nutraceutical products. S/he will work on method development/method validation projects. Typical types of testing include: assays (potencies, related substances, residual solvents, metals etc.), moisture content identification, and various other wet chemistry-based measurements. The Analytical Chemist must have the ability to efficiently organize the routine work with minimum supervision and to properly evaluate and interpret generated data is required.
· Independently designs, executes and troubleshoots wet chemistry techniques including but not limited to HPLC and/or GC, titrations, UV, DSC, TGA and IR. Test methods may be compendial (i.e. USP, EP) or proprietary methods to CURE.
· Performs analysis on raw materials and finished products
· Execute on stability programs for RD and QC
· Maintains and oversees adequate performance and maintenance of all analytical instruments in the lab
· Develops and validates new methods
· Authors method development, method validations, SOPs, and stability sections of regulatory submissions
· Performs critical interpretation of analytical data; analyzes information for technical correctness and accuracy; resolve aberrant information
· Maintains working knowledge of routine instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
· Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions
· Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Participates in company sponsored training and maintains current status of certifications.
· Prepares reports on project status and technical issues and their resolution affecting the product development
· Maintains state-of-the-art scientific and technical knowledge and innovatively integrate new approaches into the work stream within CURE.
· Works in a cross-functional environment interacting with departments such as regulatory, quality, manufacturing and project management
· Maintains a safe, clean, and organized work environment free of safety hazards
· Suggests improvements for safety, work quality, and productivity
- Performs other job-related duties as assigned
Job Requirement and Qualifications
Education: Advanced degree (preferred) in chemistry, applied/analytical chemistry, biochemistry, or related fields
Experience: Min. 5 years of industry
experience in an analytical laboratory
· Possesses broad analytical chemistry knowledge in HPLC, GCMS, UV, FTIR, dissolution and other related analytical technologies.
· Adequate understanding and ability to maintain and troubleshoot analytical equipment.
· Good understanding of USP methodologies, ICH Guidelines, cGMP and FDA regulations.
· Well versed in scientific and personal computer hardware and software applications
· Understands timelines and demonstrates a sense of urgency in work and in responding to customers and colleagues.
· Proactive, plans ahead, anticipates challenges accomplishes what is expected and adds value to the job
· Good working knowledge of Laboratory Practices with Environmental Health and Safety practices
· Ability to clearly communicate, both verbally and in writing, to all levels of the organization
· Problem Solver: Ability to apply critical and creative thinking to; improving processes, meeting challenges and solving problems
· A demonstrated commitment to high professional ethical standards and a diverse workplace
· Ability to adapt to a fast paced continually changing business and work environment while managing multiple priorities
· Consistently demonstrates honesty and integrity through personal example
· Follows all safety policies and leads by example a safety-first culture
· Complies with the company values, code of conduct and policies and regulatory standards.
May require up to 15% travel