This Principal Quality Scientist is responsible for performing new scientific and analytical method reviews for raw materials, products, and label claims. As an analytical chemistry subject matter expert and on behalf of company quality management, this role review and approves new product proposals, formulations and other technical documents as needed; performs and executes analytical research and development to support achieving company, strategic project and Quality department goals; generate new scientific proposals and lead analytical R&D efforts, investigate, identify, develop, and optimize new and existing testing methods/ techniques with emphasis on herbal and other natural products; act as a lead scientist in his/her area of expertise on one or more project teams; critically evaluate relevant scientific and regulatory information and integrate this knowledge into analytical R&D programs; set an example by creating an open environment of mutual respect and honesty and by focusing on the facts and data. Expert in botanical species used as dietary supplements.
- Conducts literature searches and scientific investigations to develops new assay methodology or to enhance methodology for existing methods for the analysis of dietary supplement raw materials and finished products including botanical materials and other naturally occurring substances.
- Provide guidance to use new assay methods for the identification and quantification of the active or marker substances in the raw materials and finished products. Instruct laboratory chemists and technicians in the use of all methods developed. Prepare or communicate written methodologies that are suitable for lab QC tests and/or for method transfer between QC labs at sister sites
- Trouble shoot existing methods and make appropriate timely recommendations on method development improvements; conducts work requiring judgment in the evaluation, selection, adaptation and modification of standard techniques, processes and criteria; review and provide technical guidance to technical challenges encountered, particularly unusual or complex problems.
- Lead and/or participate analytical method validation projects for GLP/cGMP compliance.
- Works closely with Quality and R&D colleagues to prepare, review and approval company test methods, working instructions, specifications, position papers and SOPs related to materials and products Quality Control. Review and approve formulations and master batch records on behalf of Quality Management and provide testing recommendations
- Periodically prepares research reports and technical recommendations by collecting, analyzing, and summarizing information and trends; gives presentations for both internal and external customers
- Review compendial pharmacopeial, AOAC and Dietary Supplement Industry updates and scientific reference articles for new technologies and analytical techniques for the analysis of dietary ingredients and dietary supplements; attends seminars and workshops to learn of thenewest technology and methods for the analysis of dietary supplements; communicate newly acquired knowledge to Quality Management for compliance, continuous improvement, and other considerations.
- Makes recommendations to company Quality Management for new technology and methodology transfer to the laboratory. Conducts scientific investigations to support the purchase of new laboratory instrumentation for the analysis of new entities or the enhancement of analyses for all analytics for label claims. Generate new research or development strategies to effectively address project and company goals/needs; Collaborate with functional and technical experts to facilitate scientific achievement.
- Responsible as a technical task leader within his/her area of expertise on company project teams or for specific assignments; Demonstrate the ability to resolve key technical hurdles by effectively utilizing available information and technical expertise. Participate in establishing project goals and timeline for technical tasks, and contribute to the generation of project-related documents and presentations
- Demonstrate the character of a science professional and a high degree of responsibility in maintaining scientific standards, cGMP compliance, and safe laboratory practices for self and reporting staff
- Maintain a high level of productivity in the lab, Responsible for compliance with applicable corporate policies and procedures
- Participates in dietary supplement related and science-based organizations, review industry updates, new guidance, new methods, etc. with these groups as the IVC representative.
- Sc. required (advanced degree / credentials preferred) in chemistry (analytical, organic, natural product or food chemistry preferred), biochemistry or pharmacognosy
- 10+ years (5+ years for B.Sc, M.Sc., 3+ years for Ph.D. or Post-Doc) experience in the analysis of food/dietary ingredients and dietary supplements or a similar environment, 5+ years method development/validation and natural product analytical experiences strongly preferred
- Broad experience with UPLC/HPLC, GC, MS, HPTLC/TLC, and major spectroscopy techniques preferred
- Good knowledge and experiences related to GLP, cGMP, FSMA, Quality Control and Risk Management
- Demonstrated ability to resolve major technical challenges by effectively utilizing available information and technical expertise
- Excellent time management, leadership, and communication skills (both oral and written).
- Motivated for innovation and continuous improvements with colleagues, learns fast, grasps the "essence”, and can change course quickly as required
- Ability to build excellent relationships with quality and other colleagues; proactive and motivated for best in class timely task completions and team performances
IVC is proud to be an Equal Opportunity Employer M/F/D/V - EOE