Senior Director, Biologics Drug Product Development

CMC (700) · Seattle, Washington
Department CMC (700)
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

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 BION-1301 and other biologics through development, licensure, and life cycle management in a variety of drug presentations, including biologic/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 (SME) in drug product (DP) and combination product development and manufacturing, and ensure high quality oversight of contract manufacturing organizations, consultants, and other associated vendors. In this role, the successful candidate will have responsibilities for developing and implementing strategies for drug product, including combination product, development and manufacturing. As a member of Technical Operations and CMC organization, the Senior Director, Biologics Drug Product Development is expected to significantly contribute to all aspects of the CMC strategy and work closely with Process Development, Analytical Development, Supply Chain, Technical Program Leads, Quality, and Regulatory to support Chinook’s development program strategy.

This position is remote and reports to the Executive Director, Biologics Development and Manufacturing.

 

Responsibilities include:

 

  • Lead BION-1301 biologic/device combination product design and development, technology transfer, manufacturing oversight, process characterization, and process/design validation to enable successful BLA/MAA filings.
  • Author, review, and maintain technical documents such as design history files.
  • Collaborate with BION-1301 Technical Product Team members in achieving program goals and timelines.
  • Serve as DP/device SME for regulatory filings and agency interactions.
  • Closely monitor DP/device manufacturing data, lead troubleshooting, impact assessment, and process improvement as needed.
  • Maintain a current awareness about technologies and regulatory requirements for biologics DP and combination product development.
  • Provide oversight of CMO partners and associated vendors and consultants. Build trust based on solid scientific understanding and mutual respect.
  • Work closely with Supply Chain to ensure continuous supplies for Chinook’s clinical studies and at commercial vendors.
  • Support Chinook’s JV in China, SanReno, on material and filing needs.
  • Establish and/or improve standard operating procedures for DP/device development.
  • Support due diligence and business development opportunities. Provide strategic and technical input to senior leadership to support pipeline development.
  • Build up DP/Device team based on company’s business needs. Manage group resources and budget.
  • Maintain a positive culture of technical excellence, collaboration, employee development, and goal achievement.

  

Education, Experience, and Skills:

 

  • PhD/MS in a relevant Scientific field with at least 12+ years of experience in Biologics Development and/or Operations. Direct experience in successful biologic/device combination product development is required.
  • Possess a broad technical experience/expertise across and is a SME in at least one of the following disciplines:  Biologics product development, drug device combination products development, biologics drug product manufacturing.
  • Sound understanding of CMC regulatory requirements around biologics, regulated devices, and combination products.
  • Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
  • Extensive experience in managing contract manufacturing organizations.
  • Strong leadership, interpersonal communication, collaboration and problem-solving skills; strong organizational and planning skills to determine appropriate resources.
  • Ability to travel domestically and internationally.
  • Demonstrably able to influence positive outcome without direct reporting authority.
  • Flexible and adaptable in constantly changing environments and growing organization; Able to lead and move organizations forward with environmental and organizational ambiguity. Possesses a bias for action and displays a sense of urgency.
  • Maintains extremely high quality and efficiency standards.
  • Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates.



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.

Thank You

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  • Location
    Seattle, Washington
  • Department
    CMC (700)
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor