CURE PHARMACEUTICAL Oxnard, CA
- Posted: over a month ago
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
•Performs routine sample processing for required analytical methods
•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; brings aberrant information to the attention of supervisor
•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 REQUIREMENTS 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.
WORK ENVIRONMENT/OTHER INFORMATION (Travel required, physical requirements, on-call schedules, etc.)
•Travel up to 15%