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Senior Director, Small Molecules Analytical Development

Company: Chinook Therapeutics
Location: Oakland
Posted on: January 16, 2022

Job Description:

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, Small Molecules Analytical Development will -provide -technical leadership in support of Chinook's small molecule development programs . The Senior Director, Small Molecules Analytical Development will continue lead a high-performing team of highly skilled analytical scientists to carry the development of Chinook's molecules through NDA filing, approval, label extensions, and life cycle management in a number of drug product presentations, including oral solid dosage forms. In addition, the Senior Director, Small Molecules 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 Executive Director, Analytical Development and CMC -Responsibilities include:

  • Oversee analytical method development, transfers, validation & operations and stability studies for clinical and commercial stage critical raw materials, drug substance, drug product, and finished products.
  • 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 stability reports, and provide guidance to team on various technical issues.
  • 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 12+ years of experience in Analytical Development &/ Operations.
    • Proven track record of leading analytical development/operations teams and supporting external manufacturing.
    • Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
    • Extensive experience in managing contract testing laboratories.
    • Strong leadership, interpersonal communication, collaboration and problem-solving skills.
    • 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.
    • 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.

Keywords: Chinook Therapeutics, Oakland , Senior Director, Small Molecules Analytical Development, Executive , Oakland, California

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