Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities. Chinook recently in-licensed a late-stage product, atrasentan, and plans to initiate a phase 3 trial for chronic kidney disease during 2020. Our pipeline has several other internal programs at the validation and lead optimization stages, the first of which is rapidly progressing to enter clinical trials by 2021. We are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
Chinook has raised a $65 million Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital. We are a growing team of approximately 30 employees and are based in Vancouver, British Columbia and Seattle, Washington.
The Associate Director, CMC is responsible for definition and management of contract site activities related to development and manufacturing of drug substance, drug products, and development and validation of analytical methods to support those products. This position will support products at all stages of development up to and including commercialization. This is an office-based position in our Seattle location with occasional travel both domestic and international.
- Identification and resolution of technical challenges in the areas of drug substance and drug product process development, manufacturing, and packaging, analytical method development, and technology transfer
- Creation and execution of CMC development plans for new products
- Preparation of RFPs and technical packages for the procurement of starting materials, cGMP drug substance and drug product manufacturing campaigns
- Manage the manufacture of drug substance and drug product for toxicology studies, clinical trials, and commercial supply at CDMOs, including review and approval of cGMP documentation:
• Analytical, process development and stability protocols, methods and reports
• Deviation investigations and Change documentation
• Master and executed batch records
- Oversee the development and qualification/validation of analytical methods to support starting material, intermediate, drug substance and drug product testing
- Collaborate with QA, CMC and regulatory colleagues to establish and justify release and stability specifications for starting materials, intermediates, drug substances and drug products
- Manage multiple projects, set priorities, and work in a fast-paced environment
- Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
- Author and review technical documents, development reports, and drug substance and drug product sections for IND, IMPD and global marketing applications
- Other duties as assigned
Education, Experience, and Skills:
- Ph.D. in chemistry, pharmaceutical or related discipline with minimum 8 years of experience, or Master’s with 10 years of experience, or a Bachelor’s degree with 15+ years of pharmaceutical industry experience.
- Thorough understanding of good manufacturing practices, and current industry practices for the preparation of drug substance and drug product for clinical studies and commercial supply
- Prior manufacturing experience, including management of CROs, CMOs and CDMOs
- Well-versed on global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substance and drug products and able to apply this knowledge to manufacturing strategy to control quality attributes of drug products
- Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, validation reports and specifications
- Experience in drafting CMC sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
- Thinks critically and creatively and can work independently in a fast-paced dynamic environment with multiple projects
- Ability to effectively organize and prioritize tasks to achieve established deadlines
- Excellent written, communication, and problem-solving skills
Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.