Description

Summary of Job Duties:

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.

Specific Job Duties:

1. Develop, adapt/adopt, validate, and perform methods for analysis, quantitative and qualitative, of materials and manufactured products following GMP and documentation requirements (primarily HPLC and LC/MS).
2. Utilize, where appropriate, existing method development, adaptation, and adoption pathways, including the use of published literature, and/or develop acceptable pathways.
3. Develop analytical methods and method validation documentation.
4. Train analysts in the use of the methods developed.
5. 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.
6. Collaborate with the QC Production Laboratory to improve existing methods and processes.
7. Provide expert review and guidance regarding methods, processes, and results in QC and in production of dietary supplements.
8. Consult with other departments, and review methods, materials, and equipment, to identify and implement improvements in all aspects of method development and method application.
9. Use compendial resources to develop and implement GMP compliant processes in Quality Control of dietary supplements.
10. Prepare and deliver communications at higher level view of the function, and technical details, as needed.
11. All other tasks assigned by Management.

Qualifications

Minimum Qualifications Required:

1. 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.
2. Experience in identity and quality testing of Ayurvedic, Chinese, and western botanical raw materials and extracts.
3. Comprehensive knowledge and experience in analytical and quality control method development for HPTLC, HPLC and/or LC-MS, GC.
4. Knowledge and experience in quality control of dietary supplements and /or natural products.
5. Excellent written and verbal communication skills.
6. 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.
7. Well versed in using Microsoft Office applications, particularly Excel.
8. Positive attitude, team player. Self-motivated, willing to ask questions and take initiative.

Skills and/or Training Desired:

1. Ph.D. in Pharmacognosy, Biochemistry, Chemistry, Food Science, or related field.
2. Knowledge and experience in dietary supplement formulation and development.
3. In-depth knowledge of DSHEA, dietary supplement labeling requirements, and 21 CFR Part 111.
4. In-depth knowledge of key herbal monographs and knowledge of morphological, organoleptic, and microscopic analysis of botanical ingredients.
5. Experience establishing regulated R&D, analytical chemistry and / or natural product research laboratories.
6. Experience in analytical development of GC and GC-MS methods, including headspace analysis.