Director/Senior Director, Biologics Process 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 Director/Senior Director, Biologics Process Development (PD) will provide first-class scientific and managerial leadership in support of Chinook’s BION-1301 program through clinical development, commercial launch, and life cycle management.

As a technical leader in a medium-sized company relying on a fully outsourced supply chain, the Director/Senior Director, Biologics PD will act as a subject matter expert (SME) in drug substance (DS) process and formulation development, technology transfer, and cGMP manufacturing oversight at Chinook’s contracted vendors. She/he will work closely with other functional areas in Technical Operations and Quality to ensure timely manufacture of high-quality drug substances to support Chinook’s biologics programs. She/he will also work with Technical Operations leadership in defining biologics development and manufacturing strategies and build the biologics PD team accordingly. 

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

 

Responsibilities include:

 

  • Direct development and manufacturing activities at Chinook’s DS contract manufacturing organization (CMO), including process/formulation development, technology transfer, process characterization, process validation, etc.
  • Ensure phase-appropriate DS work packages are defined and executed
  • Review and approve internal and external DS CMC documents, including but not limited to Development Plans/Protocols, Development Reports, Master Batch Records, Executed Batch Records, Manufacturing Reports, validation protocols, etc.
  • Maintain and analyze process data, closely monitor process performance
  • Author DS sections in regulatory filings, serve as DS SME in agency interactions
  • As the DS SME in the Technical Product Team, collaborate with all team members to achieve program goals and timelines
  • Maintain a current awareness about biologics manufacturing technologies, regulatory landscape, and the contract manufacturing market
  • Support Chinook’s JV in China, SanReno, in its regulatory filing needs
  • May participate in new CMO search and contract negotiations
  • May support due diligence and business development opportunities
  • Recruit and mentor additional biologics PD staff members
  • Develop and manage group budget and long-range forecast

 

Education, Experience, and Skills:

 

  • PhD/MS in a relevant scientific field with at least eight years of experience (12 years for Sr. Director) in biologics process development and/or operations.
  • Must have in-depth knowledge in developing scalable cell culture and purification processes and stable formulations for monoclonal antibody (mAb) therapeutics
  • Must have extensive experience managing CMOs
  • Must have sound understanding of cGMP and regulatory filing requirements around biologics
  • Must have successful prior IND and/or BLA filing experience
  • Experience in late-stage CMC development including process characterization and PPQ is strongly preferred
  • Experience working in a cGMP manufacturing facility is also preferred
  • Working knowledge of common mAb analytical technologies is desired
  • Strong leadership and communication skills, able to influence stakeholders and external businesses without direct reporting authority to achieve positive outcomes
  • Attentive to details and capable of finding solutions to complex problems
  • A team player who can collaborate effectively across functional areas
  • Ability to travel domestically and internationally.



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