Chinook Therapeutics

Associate Director, Quality Control

Quality Assurance (850) - Remote, Washington

Company:

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Up to 10% of the global population suffers from kidney disease and in the U.S. alone, kidney diseases account for over $130 billion in annual costs.

At Chinook Therapeutics our purpose is to discover and develop precision therapies to preserve kidney function and make dialysis and transplant unnecessary for people living with kidney disease. We strive for excellence in all we do and think big in our innovation; our highest priority is to do the right thing for patients while working together and having a whole lot of fun!

Our pipeline of precision medicines targets rare, severe kidney disorders with few currently approved therapies. For more information on Chinook and our pipeline, check out our site www.chinooktx.com/about & www.chinooktx.com/pipeline. We trade on Nasdaq under the ticker symbol KDNY and are headquartered in Seattle, WA with offices in Vancouver, BC, and Oakland, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce –come and be a part of our growth.

At Chinook, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here.

Position:

The Associate Director of Quality Control will serve as a quality professional in ensuring oversight and execution of GMP related analytical testing of small molecule drug substance and drug product at contract manufacturers and contract laboratories. The analytical testing includes starting materials, reference standards, in-process, release, and stability testing as well as methods validation and transfer. This role supports Chinook’s quality culture through collaborating externally and with CMC & Technical Operations, and other internal stakeholders to ensure product quality, data integrity and regulatory compliance of late phase and commercial programs. The Associate Director of Quality Control will report to the Head of Quality Control.

Responsibilities include:

• Oversees contract manufacturing organization (CMO) and contract laboratory (CTL) GMP testing activities, manages contract laboratory vendors, monitors laboratory performance, and ensures improvement and preventative actions are taken if needed.
• Provides QC review of testing data packages and leadership to laboratory testing investigations.
• Oversees stability activities, performs data entry and trending using stability software, authors and/or reviews stability protocols/reports.
• Oversees analytical method validation/transfer, including protocol/data/report/test procedure review and approval.
• Oversees reference standards qualification and inventory for continuous testing supply.
• Works with CMC Technical Operations and Regulatory Affairs to author and review applicable sections for IND/IMPD and NDA/MAA submissions.
• Supports regulatory inspections and internal audits, including gap identification and closure for inspection readiness.
• Ensures collection, analysis, and approval of data to support annual product quality reviews, specifications, and product quality trending.
• Supports the continuous improvement of methods, processes, and systems to assure the quality of testing of Chinook products.
• Participates in the selection and auditing of contract organizations as needed.
• Contributes to the development and maintenance of a positive team-focused company culture and a culture of quality by collaborating across all departments to accomplish company objectives.
• This position requires travel potentially up to 10%.
• Other duties as assigned.

Location:

Chinook has offices located in Seattle WA, Oakland CA, and Vancouver BC

• This position may be located at any Chinook office location or remote (within US or Canada) with preference given to candidates located in the vicinity of a Chinook office.

Education, Experience, and Skills:

Required

• 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 10 years of experience in the pharmaceutical industry with hand-on experience in small molecule analytical method development and/or method validation/transfer.
• Solid understanding of small molecule analytical test methods (e.g., Assay, impurity, ID, Residual Solvent, dissolution, KF etc.) with experience in method development and /or validation.
• Experience in small molecule QC testing and data review in a GMP environment.
• Must be detail-oriented with a commitment to accuracy and excellent review quality.
• Working knowledge with cGMP requirements and ICH guidance.
• Demonstrated track record of CMO/CTL management.

Preferred:

• Demonstrates initiative and proactively collaborate with internal and external stakeholders as a credible and clear communicator.
• Must have 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.
• 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.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Experience with iStability software and statistical tools such as Minitab, JMP/SaS, and/or GraphPad is a plus.
• Experience with biologics test methods is a plus.

Salary Range: $161,000 - $188,000

Benefits:

• Paid parental leave
• Vacation and Sick time
• Living organ donor leave
• Volunteer time off
• 15 Paid Holidays
• Hybrid Work
• Flexible scheduling
• Healthcare plans
• Retirement Matching
• Financial wellness programs
• Employee assistance programs (EAPs)
• Internal learning & development courses

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.

To Apply:

Chinook Therapeutics

Chinook Therapeutics is an Equal Opportunity Employer

Submitted: 02/04/2023