Company:
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 1/2 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 Oakland, CA.
Position:
The Senior Director, Biologics Drug Product Development will provide first-class scientific and managerial leadership in support of Chinook’s biologics development programs in support of BION-1301 and other biologics through BLA, approval, label extensions, and life cycle management in a variety of drug presentations, including drug device combination presentations.
As a technical leader in a medium-sized company relying on a fully-outsourced supply chain, the Senior Director, Biologics Drug Product Development will act as a subject matter expert (SMEs) in drug product and device development and manufacturing, and ensure high quality oversight of contract manufacturing organizations, consultants, and other associated vendors as well as support the establishment of a trusted network of agile outsourcing partners to support Chinook’s BION-1301 activities. In addition, the Senior Director, Biologics Drug Product Development is expected to significantly contribute to all aspects of the CMC strategy and work closely with Process Sciences, Analytical Development, Supply Chain, Technical Program Leads, Quality, and Regulatory to support Chinook’s development program strategy. In this role, the successful candidate will have responsibilities for developing and implementing strategies for formulation/drug product development and manufacturing, technology transfers as needed, fill/finish process characterization, development of drug/device combination products and associated design history files and manufacturing and assembly processes as well as all associated regulatory filings. As a technical leader in a medium-sized, virtual company, the Senior Director, Biologics Drug Product Development will actively create and sustain a trusted network of agile outsourcing partners and consultants to support Chinook’s development activities. As a member of Technical Operations and CMC organization, this person will interact routinely with peers in the department and throughout the company, occasionally with Chinook’s global project teams and leadership team.
This position is remote and reports to the Executive Director, Biologics Development and Manufacturing.
Responsibilities include:
Education, Experience, and Skills:
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.
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