Director, Quality Control
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.
The Director, Quality Control, will ensure that activities related to release, stability testing and method validations are completed promptly at contract service providers (CSPs) associated with the manufacture of drug substance and drug product for Tricida. Responsibilities include technical review of protocols associated with method validations, transfers and stability studies. Strong analytical skills and prior experience in root cause analysis, deviation management and change control is required. Prior experience with product development activities and special studies required to support an NDA application is required. Prior experience with managing CSPs is required. The successful candidate must possess strong understanding of cGMP requirements and ICH, FDA and other pharmaceutical industry regulatory guidelines. This position will collaborate closely with cross-functional team members, including analytical development, quality assurance, process development, regulatory and clinical operations.
- Ensure release testing of drug substance and drug product at CSP’s meets GMP requirements and project timelines.
- Drive analytical method validations/transfers for drug substance and drug product at CSP’s. Write/review method validation and transfer protocols and reports. Ensure technical and regulatory compliance.
- Provide leadership for in-house and CSP laboratory investigations related to discrepancies and deviations, OOS/OOTs results to ensure prompt and thorough investigations.
- Periodically evaluate and propose improvements to existing analytical methods. Plan and facilitate experiments to support method validation/transfer activities as required.
- 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.
- Establish, monitor and report key QC performance indicators/metrics for quality management review; use the indicators/metrics to drive operational, process and quality improvements.
- Prepare and review CMC/Quality sections of US and ex-US regulatory filings.
- Keep abreast of industry developments and translate into corporate requirements and standards for analytical QC testing and stability programs.
Experience and Skills:
- Ph.D. in Analytical Chemistry or related scientific disciplines with 10+ years of experience in analytical development and minimum of 5+ years’ experience in QC.
- Extensive expertise in chromatographic and spectroscopic analytical techniques.
- Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing.
- Prior experience related to managing external CSPs.
- In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. Experience with late stage development products a plus.
- Working knowledge of cGMP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines.
- Detail-oriented with exceptional organizational, leadership and project management skills.
- Excellent written and verbal communication skills.
- Self-directed individual who is able to work in a fast-paced, changing yet collaborative environment.
- Must have life sciences industry background and prefer some previous “startup” company experience.
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.