Chinook Therapeutics Job Description:
Sr. Director, Quality Control
Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.
Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Berkeley, CA.
The Sr. Director of Quality Control will serve as a strategic and tactical quality professional in ensuring oversight and execution of all aspects of GMP/GLP/GCP related analytical testing. Responsible for ensuring oversight of contract laboratories, method transfers, and testing performed by manufacturers, including starting materials, in-process, release, and stability testing for late phase development programs throughout the product lifecycle. The Sr. Director of QC supports Chinook’s quality culture through collaborating externally and with Analytical Development, Technical Operations, and other internal stakeholders to ensure method transfers, method validation, expiration dating, specification setting, and QC data integrity is established and maintained for late phase and commercial programs. The Sr. Director of Quality Control will preferably be based in one of the Chinook West coast offices (Vancouver, BC; Seattle, Washington; Berkeley, CA; San Diego, CA) and will report to the Vice President of Quality.
- Contributes to the development and maintenance of a positive team-focused company culture and a culture of quality by collaborating across all departments and levels of management to accomplish company objectives and represent QC.
- Oversees CMO and contract laboratory GMP testing of reference standards, starting materials, in-process, release, and stability testing throughout the product lifecycle for all Chinook programs. Manages contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve if needed.
- Responsible for method transfers and analytical method validations for late phase and commercial testing and ensuring QC data integrity, including QC review and approval of documents.
- Establishes processes and ensures collection, analysis, assessment and approval of data to support annual product quality reviews, specifications, stability, and product quality trending.
- Directly interface with contract laboratories, manufacturers, regulators, and GMP Quality Compliance in support of internal and external audits and inspections of Chinook programs, including inspection readiness activities. Audit and inspection responsibilities include support and preparation of responses to observations and ensuring response CAPAs are effective
- Planning, coordination, and continuous improvement of methods, processes, and systems to assure the quality of testing of Chinook products. Provide input and change management for quality improvements affecting QC methods and processes.
- Development and implementation of testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and documents that support the Quality Management System.
- Ensure that the QC organization meets key performance indicator goals. Includes meeting and exceeding internal stakeholder and customer expectations.
- Builds and maintains expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities where required.
- Work with CMC Technical Operations and Regulatory Affairs to author and review applicable sections of IND/IMPD and NDA/MAA submissions to ensure data and documents meet GMP guidelines.
- This position requires travel up to 20%.
- Other duties as assigned.
Education, Experience, and Skills:
- The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, or equivalent science program.
- Minimum of 15 years of experience in the pharmaceutical industry with experience leading a Quality Control function, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with at least 5 years in a GMP QC release testing role.
- Significant experience in an FDA-regulated environment.
- Broad knowledge of QC processes and procedures, LIMS systems, and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulations.
- Demonstrates initiative and proactively provides collaborative support to the internal and external stakeholders as a credible communicator.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks. Continuously demonstrates a positive, ‘can do’ and service-oriented attitude.
- Strong oral and written communicator; detail-oriented with a commitment to accuracy. Ability to plan and organize work in an efficient manner, multi-task and shift priorities quickly while working under time constraints. Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Chinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We respect and value different experiences and viewpoints. We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.