Senior Director, Small Molecules Analytical Development
Company: Chinook Therapeutics
Posted on: January 16, 2022
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
- Oversee analytical method development, transfers, validation &
operations and stability studies for clinical and commercial stage
critical raw materials, drug substance, drug product, and finished
- 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
- Escalate significant analytical issues to management and
project teams in a timely manner, drive mitigation or
- Provide technical support for regulatory filings, health
authority questions, change control and quality impact
- 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 &/
- Proven track record of leading analytical
development/operations teams and supporting external
- Strong knowledge of Quality, Compliance, US & International
cGxPs, regulations, product development and manufacturing.
- Extensive experience in managing contract testing
- Strong leadership, interpersonal communication, collaboration
and problem-solving skills.
- Ability to travel domestically and internationally.
Demonstrably able to influence positive outcome without direct
- Flexible and adaptable in constantly changing environments and
- 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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