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 as well as defined and rapid clinical development opportunities. Chinook’s pipeline currently has several rapidly progressing internal programs at the validation and lead optimization stages poised to enter clinical trials by 2021. We are also evaluating business development opportunities for early and late-stage clinical assets to enhance our pipeline.
Chinook has raised $65 million in Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital. We are a growing team of approximately 25 employees and are based in Vancouver, British Columbia and Seattle, Washington.
In anticipation of a potential initiation of a late-stage clinical program for Chinook’s growing pipeline, we have a new opportunity for a Head of CMC. The Head of CMC is responsible for leading all aspects of Chemistry, Manufacturing and Control (CMC) activities across Chinook’s pipeline from discovery through to global approvals and commercialization. This role will serve on global project teams, responsible for process optimization, clinical manufacturing, process validation and assisting with regulatory filings. The position will be based in Seattle, Washington or Vancouver, BC, report to the CEO and have broad functional leadership responsibility.
- Building and leading the CMC function and ensuring appropriate strategies, systems and processes are in place to support development, manufacturing and commercialization
- Managing CMOs, including vendor selection, negotiating contracts and work orders, vendor communication, and overseeing vendor activities to assure product specifications, quality, safety and budgets meet necessary requirements
- Ensuring CMC timelines meet corporate goals and projects stay on schedule
- Preparing and compiling CMC regulatory documents for investigational and market approval regulatory filings in multiple jurisdictions
- Developing validation strategy and oversee validation plans, validation protocols, execution of experiments, and final validation reports identifying and implementing quality by design validation strategies where possible and appropriate
- In collaboration with QA, reviewing and approving master batch records, executed batch records and other GMP manufacturing documents
- Working in close collaboration with QA to ensure quality system compliance
- Partnering with the executive leadership team on presentations to the Board of Directors, investors, potential corporate collaborators and other external constituents as required
- Contributing to the development and maintenance of a positive team-focused company culture
Education, Experience, and Skills:
- PhD or MS in a pharmaceutical sciences, chemistry or engineering discipline and a minimum of 10 years progressive biotech or pharmaceutical industry experience
- Experience in a cGMP environment and small molecule manufacturing
- Proven ability to effectively manage international CRO/CMOs for the manufacture of cGMP APIs and DPs
- Experience with IND, CTA and NDA filings; thorough knowledge of relevant regulations and GMP requirements
- Strong leadership skills and proven ability achieve successful outcomes in collaboration with internal team and external collaborators, meeting project budget and timelines
- Experience with all phases of pharmaceutical development, including complex late stage development programs and US/foreign filings is required, and commercial experience is an asset
- Solution-oriented team player with executive presence and demeanor, excellent written and verbal communication skills, and outstanding analytical abilities
- Ability to adapt quickly to changing environments and priorities
- Positive attitude and high personal and ethical standards in achieving corporate goals
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.