Senior Director, Biologics Drug Product 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 Senior Director, Biologics Drug Product Development will provide first-class scientific and managerial leadership in support of Chinook’s biologics development programs in support of BION-1301 and other biologics through BLA, approval, label extensions, and life cycle management in a variety of drug presentations, including drug device combination presentations.  


As a technical leader in a medium-sized company relying on a fully-outsourced supply chain, the Senior Director, Biologics Drug Product Development will act as a subject matter expert (SMEs) in drug product and device development and manufacturing, and ensure high quality oversight of contract manufacturing organizations, consultants, and other associated vendors as well as support the establishment of a trusted network of agile outsourcing partners to support Chinook’s BION-1301 activities. In addition, the Senior Director, Biologics Drug Product Development is expected to significantly contribute to all aspects of the CMC strategy and work closely with Process Sciences, Analytical Development, Supply Chain, Technical Program Leads, Quality, and Regulatory to support Chinook’s development program strategy. In this role, the successful candidate will have responsibilities for developing and implementing strategies for formulation/drug product development and manufacturing, technology transfers as needed, fill/finish process characterization, development of drug/device combination products and associated design history files and manufacturing and assembly processes as well as all associated regulatory filings. As a technical leader in a medium-sized, virtual company, the Senior Director, Biologics Drug Product Development will actively create and sustain a trusted network of agile outsourcing partners and consultants to support Chinook’s development activities. As a member of Technical Operations and CMC organization, this person will interact routinely with peers in the department and throughout the company, occasionally with Chinook’s global project teams and leadership team. 

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

 

Responsibilities include: 

 

  • Provide strategic and technical support for all biologics formulation/drug product development and manufacturing, technology transfers as needed, fill/finish process characterization, process validation; development of drug/device combination products and associated design history files; device manufacturing and assembly processes development and validation; all associated regulatory filings and regulatory interactions. 
  • Support Technical product Lead in achieving program goals and timelines. 
  • Maintain a current awareness about biologics development and associated drug/devices combinations.  
  • Provide oversight of CMO partners and associated vendors and consultants. Build trust based on solid scientific understanding and mutual respect. 
  • May lead technical assessment and new vendor selection and RFP process for relevant activities. 
  • Works closely with Chinook’s JV in China, SanReno, to support materials and filing needs. 
  • Work closely with Supply Chain to ensure continuous supplies for Chinook’s clinical studies and at commercial vendors. 
  • Provide strategic and technical support for regulatory filings, health authority questions, change control and quality impact assessments.  
  • Act as technical expert to evaluate and challenge the data generated in a wide range of activities to ensure that processes are robust. Serve as a resource to his/her peers regarding continuous improvement, problem solving and strategic, as well as, tactical decisions within the Company.  
  • Establish and/or improves standard operating procedures as they relate to key CMC processes. May support creation of new relevant SOPs. 
  • Support due diligence and business development opportunities.  
  • Actively engage in creating a positive culture with key internal team members, stakeholders (Quality, Regulatory, Research) and external customers. 
  • Mentor staff and team.  
  • Maintain a positive culture of technical excellence, collaboration, employee development, and goal achievement.  
  • Develop and manage group resources and budgets  
  • Provide strategic and technical input to senior leadership to inform pipeline development and other relevant business activities.  

 

Education, Experience, and Skills: 

 

  • PhD/MS in a relevant Scientific field or Biotech industry with at least 12+ years of experience in Biologics Development and/or Operations. Experience in all stages of development of approved drug device biologics combination product required. 
  • Possesses a broad technical experience/expertise across and is a SME in at least one of the following disciplines:  Formulation development, biologics product development, drug device combination products development, biologics manufacturing. 
  • Sound understanding of CMC regulatory requirements around biologics, regulated devices and combination products. 
  • Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing. 
  • Extensive experience in managing contract manufacturing organizations.  
  • Strong leadership, interpersonal communication, collaboration and problem-solving skills; strong organizational and planning skills to determine appropriate resources.  
  • 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; Able to lead and move organizations forward with environmental and organizational ambiguity. Possesses a bias for action and displays a sense of urgency. 
  • Maintains extremely high quality and efficiency standards.  
  • Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates.  
  • Drives and support the 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.

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  • Location
    Seattle, Washington
  • Department
    CMC (700)
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor