Chinook Therapeutics

Director, Biologics Analytical Development

CMC (700) · Remote, Washington

Company:

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Up to 10% of the global population suffers from kidney disease and in the U.S. alone, kidney diseases account for over $130 billion in annual costs.

At Chinook Therapeutics our purpose is to discover and develop precision therapies to preserve kidney function and make dialysis and transplant unnecessary for people living with kidney disease. We strive for excellence in all we do and think big in our innovation; our highest priority is to do the right thing for patients while working together and having a whole lot of fun!

Our pipeline of precision medicines targets rare, severe kidney disorders with few currently approved therapies. For more information on Chinook and our pipeline, check out our site www.chinooktx.com/about & www.chinooktx.com/pipeline. We trade on Nasdaq under the ticker symbol KDNY and are headquartered in Seattle, WA with offices in Vancouver, BC, and Oakland, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce –come and be a part of our growth.

At Chinook, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here.

Position:

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

Responsibilities include:

• Oversee analytical method development, transfer, validation, and operations, including release and stability studies, for: drug substance, drug product, finished products, 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/reports, specifications, and comparability protocols.
• 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, and external customers.

Location:

Chinook has offices located in Seattle WA, Oakland CA, and Vancouver BC

• This position may be located at any Chinook office location or remote (within US or Canada).

Education, Experience, and Skills:

Required

• PhD/MS in a relevant Scientific field or Biotech industry with at least 10+ years of experience in Analytical Development and/or 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.
• Ability to travel domestically and internationally.
• Strong leadership, interpersonal communication, collaboration, and problem-solving skills.

Preferred:

• Drug product and device testing experience.
• IND/IMPD/BLA/MAA authoring and filing strategy experience.
• Demonstrate ability to influence positive outcome without direct reporting authority.
• Flexible and adaptable in constantly changing environments and growing organization.
• Displays a sense of urgency and action oriented.
• Maintains extremely high quality and efficiency standards.
• Contribute to the development and maintenance of a positive team-focused company culture.

Salary Range: $204,000 - $238,000

Benefits:

• Paid parental leave
• Vacation and Sick time
• Living organ donor leave
• Volunteer time off
• 15 Paid Holidays
• Hybrid Work
• Flexible scheduling
• Healthcare plans
• Retirement Matching
• Financial wellness programs
• Employee assistance programs (EAPs)
• Internal learning & development courses

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.

To Apply:

Chinook Therapeutics

Chinook Therapeutics is an Equal Opportunity Employer

Submitted: 01/25/2023