Senior Scientist, Quality Control
Working with fellow accomplished scientists, as Sr. Scientist, QC, you will facilitate oversight of contract service providers (CSPs) engaged in drug substance and drug product manufacturing. Strong analytical skills and prior experience in root cause analysis and deviation management are critical. You will collaborate closely with cross-functional team members, including analytical development, quality assurance, process development, regulatory and clinical operations. You will also review protocols, reports and data associated with method validations, transfers and stability studies. The successful candidate must possess strong understanding of cGMP requirements and ICH, FDA and other pharmaceutical industry regulatory guidelines.
Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies. Tricida’s lead investigational drug candidate, TRC101, represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of chronic kidney disease (CKD) that can result in increased mortality, accelerated progression of kidney disease, progressive muscle breakdown and exacerbation of bone disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and motivated professionals to bring new drug candidates into clinical development.
- Support analytical method validations/transfers for release testing of intermediate, drug substance and drug product at CSP’s. Write/review method validation and transfer protocols and reports. Ensure technical and regulatory compliance.
- Review data packages associated with method validation, transfer, and stability testing against established criteria. Ensure compliance with cGMP and internal SOP’s.
- Periodically evaluate and propose improvements to existing analytical methods. Plan and conduct lab experiments to support method validation/transfer activities as required.
- Review data package and related documentation associated with cGMP release/stability testing, deviations, change controls. Communicate issues related to testing with CSPs. Ensure timelines are met.
- Assist in investigations and deviations occurring at CSPs. Plan and conduct lab experiments to identify/confirm root cause of anomalous results as required.
- Write/review protocols and reports related to stability studies as well as prepare tables summarizing results from stability studies.
- Establish a system for tracking and trending release and stability data for batch analysis and shelf life establishment.
- Maintain internal change control for validated methods and regulatory documents, and assist in the change control process at CSP’s.
- Monitor reference standard program for drug substance and related substances at CSP’s.
EXPERIENCE AND SKILLS:
- B.S. or M.S in Analytical Chemistry or related scientific disciplines with 10+ years’ experience in analytical development, with minimum of 5+ years of experience in quality control.
- Extensive expertise in chromatographic and spectroscopic analytical techniques.
- Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing.
- Working knowledge of cGMP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines.
- Detail-oriented with exceptional organizational skills.
- Excellent written and verbal communication skills.
- Self-directed individual who is able to work in a fast-paced environment.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
Tricida is located in South San Francisco, CA.
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