Associate Director, Biologics Analytical 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 Associate Director, Biologics Analytical Development support Chinook’s biologics development programs. The Associate Director, Biologics Analytical Development work with a team of high-performing, highly skilled analytical scientists to carry the development of Chinook’s biologics through BLA filing, approval, label extensions, and life cycle management in a number of drug product presentations, including drug device combination products. In addition, the Associate Director, Biologics Analytical Development is expected to work closely with internal and external resources to oversee analytical activities at various contract test laboratories.  This position is remote and reports to the Senior Director, Biologics Analytical Development.

 

Responsibilities include:

 

  • Support analytical method development, transfers, validation & operations and stability studies for clinical and commercial stage critical raw materials, drug substance, drug product, finished product and device.
  • Provide oversight for contract analytical services and the transfer of analytical methods to CRO and CMO partners.
  • Review and approval of relevant analytical documents including method validation protocols and reports, specifications, and comparability protocols, and provide guidance to team on various technical issues.
  • Review of lot release and stability data packages, performing data trending, and writing stability reports to support shelf-life.
  • Stability data tracking and trending.
  • Escalate significant analytical issues to management and project teams in a timely manner, drive mitigation or problem-solving activities.
  • Provide technical support for regulatory filings, health authority questions, change control and quality impact assessments.
  • Build collaborative relationships with key internal team members, stakeholders (Quality, Regulatory) and external customers.

 

Education, Experience, and Skills:

 

  • PhD/MS in a relevant Scientific field or Biotech industry with at least 5+ years of experience in Analytical Development &/ Operations, or at least 10+ years of experience in  Analytical Development &/ Operations
  • Experience with developing, testing, and transferring bioassays a plus.
  • Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
  • Experience in providing oversight to contract testing laboratories.
  • Strong interpersonal communication, collaboration and problem-solving skills.
  • Ability to travel domestically and internationally.
  • Flexible and adaptable in constantly changing environments and growing organization. Possesses a bias for action and displays a sense of urgency.
  • Maintains extremely high quality and efficiency standards.
  • Contribute to the development and maintenance of a positive team-focused company culture.



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