Skingenix Inc., a leader in dermal regeneration technologies, located in Ontario, California. As an innovative and mission-driven company, Skingenix pursues a standard of excellence in the regenerative medical industry with an emphasis on developing organ in-situ regenerative products for improving human health and quality of life.
This position will focus on natural ingredients characterization and quality control method developments for herbal originated drug product, drug substance and botanical raw materials. In the development stage of the product this role may also perform some of the quality control tests.
Essential Duties and Responsibilities
1. Work in house and with CRO to characterize the herbal originated drug product, including herbal extract component identification and structure elucidation.
2. Develop both quantitative or qualitative methods, including finger printing methods for botanical ingredients in herbal drug product, drug substance and botanical raw materials.
3. Stressed Product characterization per ICH requirements.
4. R&D problem solving using state of the art analytical instruments.
5. Support manufacture process development, such as sterile process evaluation, container leachable evaluation, process trouble shooting etc.
6. Support OOS/OOT investigation for QC testing.
7. Serve as subject matter expert in botanical chemistry for the cross functional problem solving.
8. Performs other duties inherent of the position, and additional duties that may be assigned by supervisor.
Education, Knowledge and Skills Requirements
1. Solid knowledge and working experience in botanical chemistry and/or organic chemistry.
2. Strong background in analytical method development for botanicals/herbals.
3. Experienced with state of the art analytical instruments, such as HPLC, GC, MS as well as routine analytical equipment. In-depth knowledge of high resolution mass spectrometry and NMR are great plus.
4. Technical mastery in analysis of natural herbal products with innovative and creative problem solving skill.
5. Candidate with Bachelor’s Degree requires 5+ years of relevant industry working experience, Master’s Degree requires 3+ years of relevant industry working experience, or PhD Degree with relevant botanical research experience.
6. Willingness to travel up to 10% to CROs, various meetings or training.