Senior Director, Pharmaceutical 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 1b 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 Berkeley, CA.


Position:

The Senior Director, Pharmaceutical Development will lead pharmaceutics formulation, drug product development and manufacturing for all of Chinook’s small molecule programs at all stages of development and through commercialization. The successful candidate will direct and oversee contract development and manufacturing organizations (CDMOs) as well as lead pharmaceutics development efforts and tech transfers in preparation for successful process validation and NDA/MAA submissions as well as commercial launch.

 

The job is virtual and reports into the Executive Director, Small Molecules Technical Development and Manufacturing.

 

 Responsibilities include:

 

  • Provide strategic oversight and lead a high performing team for pre-formulation, and drug product development and optimization activities to produce scalable, efficient, and cost-effective small molecule drug product manufacturing processes.
  • Drive continuous improvements in the drug product development process through technological innovation and problem-solving.
  • Select and manage phase appropriate CDMOs for drug products at all stages of development.
  • Establish and maintain strong working relationships with external CDMO partners and enhance the CDMO network to expand the capability and capacity of Chinook development and manufacturing.
  • Provide technical and scientific direction to CMOs and external laboratories to ensure project deadlines and performance standards are met.
  • Responsible for functional area leadership in technical issue resolution with CMO partners.
  • Act as a subject matter expert (SME) in leading process development studies, specification justification studies to establish limits, process characterization studies to identify proven acceptable ranges of critical process parameters, including identification of edge-of-failure and critical quality attributes.
  • Partner with team members to support process validation activities and strategies including support of process risk assessments and control strategies throughout process validation.
  • Analyze and interpret results and methods, troubleshoot problems, generate solutions to problems and meet phase appropriate regulatory expectations for process development.
  • Review drug product manufacturing records. Provide innovative solutions in investigations and troubleshooting and resolve deviations in compliance with cGMPs and internal SOPs.
  • Support audits and regulatory inspections.
  • Author technical and regulatory documentation as required, including development plans, engineering protocols, risk assessments, technical reports, change controls, and IND/IMPD/NDA/MAA Quality sections.
  • Write and/or review responses to regulatory agencies (FDA, EMA) questions to the highest caliber.
  • Working closely with Project Management, develop and manage project timelines, and budgets for all small molecule formulation development activities.
  • Participates on CMC teams and partners closely with other functions including Chemical Development, Analytical Development, Quality, and Regulatory from preclinical to commercial stages.
  • Establish standard operating procedures as they relate to pharmaceutical development and clinical manufacture, validation.
  • Provide strategic and technical input to senior leadership to inform pipeline development and other relevant business activities.
  • People manager for Pharmaceutical Development; Maintain a culture of technical excellence, collaboration, employee development, and goal achievement.


Education, Experience, and Skills:

 

  • Ph.D. in Pharmaceutical Sciences (or related discipline) with 15+ years of experience in the Pharmaceutical or Biotech industry or demonstrated track record of successfully developing processes and validating drug products.
  • Experience in mid- to late-stage development of an approved pharmaceutical product required.
  • Extensive knowledge and expertise in the solid oral dosage development, scale-up, characterization, optimization, and validation of drug product manufacturing processes.
  • Experience in pediatric formulation development is desirable.
  • Detailed expertise in blending and material mixing technologies as related to blend and content uniformity and in granulation technologies such as fluid-bed, high-shear, roller compaction, and tablet compression and coating.
  • Proven experience with particle control technologies such as milling, micronization, and spray drying.
  • Demonstrated ability to manage outsourced formulation development activities in a virtual environment both domestically and internationally.
  • A record of contribution and innovation in small molecule pharmaceutical development programs including the resolution of pharmaceutical development and manufacturing challenges.
  • Demonstrated success in shepherding late-phase drug product characterization to validation, pre-approval inspection, and commercial manufacturing.
  • Good knowledge of statistics, including Design of Experiments and statistical process control required. Well-versed and demonstrated success in the application of QbD principles.  
  • Good knowledge of risk management principles and techniques, including FMEA.
  • In depth understanding of contemporary ICH and health authority requirements and the current areas of regulatory focus.
  • Expertise in technical evaluation and management of CDMOs and other suppliers.
  • Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive)
  • Extensive experience in managing contract manufacturing organizations in North America, Europe, and Asia.
  • Strong leadership, interpersonal communication, collaboration and problem-solving skills along with strengths in delivering results on firm deadlines in support of development programs.
  • Have strong organizational and planning skills to determine appropriate resources for the resolution of problems.
  • Leadership, coaching, and mentoring of direct reports.
  • Ability to travel domestically and internationally up to 25% of the time.
  • 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.
  • Exemplary skills in leadership, communication, project management and budget management while maintaining extremely high quality and efficiency standards.
  • Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates.
  • Exemplifies excellent interpersonal skills. Demonstrably able to influence positive outcome without direct reporting authority.  
  • 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