Natural Products Chemist

THRESHOLD ENTERPRISES LTD•Scotts Valley, CA

1d•$74,000•Onsite

About The Position

The Natural Products Chemist is a leadership role for the analytical research and development function. This position supports critical projects including the development of new dietary supplement products, development of laboratory technology and techniques, method development and validation, support of existing product testing, and continuous improvement. This position will collaborate interdepartmentally with QC and R&D, in addition to working with external resources, to develop and validate analytical methods for the characterization of raw materials, intermediates and finished bulk products, to provide scientific substantiation for label claims, and to ensure that all products meet regulatory requirements. The Natural Products Chemist will collaborate with the Quality Control Lab team in the development and validation of new methods and the review and improvement of existing methods, processes and practices. This position will play a crucial role in developing and executing strategies to improve GMP compliance and achieve company and departmental goals.

Requirements

M.S. in Pharmacognosy, Biochemistry, Chemistry, Food Science, or related field with 10 years of relevant experience, or an equivalent combination of education and experience, with expertise in analyzing botanicals.
Extensive experience in GMP/GLP laboratory settings with strong documentation skills.
Skilled in the setup and maintenance of laboratory tools and equipment.
Comprehensive knowledge and experience in HPLC and LCMS analytical method development and transfer to Quality Control for routine analysis.
Comprehensive knowledge and experience in HPTLC analysis to support identification and botanical quality determinations.
Knowledge and experience in quality control of dietary supplements and /or natural products.
Excellent written and verbal communication skills.
Ability to interact productively and effectively with a wide variety of people and functions to facilitate the teamwork needed to efficiently accomplish product development and production goals.
Well versed in using Microsoft Office applications, particularly Excel.
Positive attitude, team player. Self-motivated, willing to ask questions and take initiative.

Nice To Haves

Ph.D. in Pharmacognosy, Biochemistry, Chemistry, Food Science, or related field.
Experience establishing regulated R&D, analytical chemistry and / or natural product research laboratories.
Experience in the use of LC-MS equipment and methodology.
Experience in analytical development of GC and GC-MS methods, including headspace analysis.
Experience in analytical development of ICP-MS methods for metals and Metallo compound analysis.
Knowledge and experience in dietary supplement formulation and development.
In-depth knowledge of DSHEA, dietary supplement labeling requirements, and 21 CFR Part 111.
In-depth knowledge of key herbal monographs and knowledge of morphological, organoleptic, and microscopic analysis of botanical ingredients.

Responsibilities

Develop, validate, and execute methods for the analysis of raw materials and products
Primarily quantitative methods by HPLC, LCMS, GC, and ICP-MS
Qualitative methods by HPTLC
Miscellaneous chemistry methods
Strong adherence to GMP/GLP and documentation requirements
Develop review and approve documentation in support of method development and validation
Train analysts in the use of the methods developed and transfer to QC for routine testing.
Provide leadership for and collaborate with the QC Laboratory in developing / adapting methods to perform all required analytical processes for the development of new dietary supplement products and for the evaluation of existing products.
Collaborate with the QC Production Laboratory to improve existing methods and processes.
Collaborate with QC, R&D and Executive leadership to enhance laboratory technologies and capabilities.
Participate in troubleshooting/investigations as a subject matter expert in laboratory methods and systems.
Prepare and deliver communications at higher level view of the function, and technical details, as needed.
All other tasks assigned by Management.