Job Summary

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. 

Essential duties/Responsibilities

·         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

Functional Competencies:

·         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

 Behaviors

·         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