CMC Project Management (Sr. Manager/Associate Dir.)

CMC · Seattle, Washington
Department CMC
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

Chinook Therapeutics Job Description: CMC Project Management (Sr. Manager/Associate Dir.)

 

Company:

 

Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and defined and rapid clinical development opportunities. Our lead program, atrasentan, is a late-stage clinical program for the treatment of primary glomerular kidney diseases planned to move into a phase 3 trial for IgA nephropathy by 2021. We are also advancing CHK-336 towards a planned IND in 2021 for an ultra-orphan kidney disease. In addition, our pipeline has several other internal programs at the validation and lead optimization stages and we are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.

 

Chinook raised a $65 million Series A financing in 2019 from leading healthcare investors Versant Venture, Apple Tree Partners and Samsara Biocapital, and recently announced a proposed merger with Aduro Biotech, Inc., which we expect to close in the second half of 2020. Chinook will be the surviving company following the merger and will trade on Nasdaq.
Chinook currently has approximately 45 employees and is based in Seattle, Washington and Vancouver, British Columbia.

 

Position:

 

The CMC Project Manager has an overall understanding of CMC function, with responsibility for managing key activities across CMC disciplines. This position will work with internal project teams covering early to late stage development, registration, and commercialization, and external partners including CMOs and CROs. This position reports to our Executive Director, CMC, and is based out of Chinook's Seattle location.


Responsibilities include:

 

  • Coordinate CMC activities and team meetings with CMOs or other external partners by planning meeting agendas, providing minutes, and ensuring milestones and action items are assigned, tracked, and completed.
  • Develop and manage integrated CMC timelines for contract manufacturing partners (CMOs), and internal teams for clinical product development, analytical development, drug substance and drug product manufacturing and release of clinical batches.
  • Manage CMC-related activities including but not limited to regulatory filings, budget tracking, quarterly accruals, long range planning, purchase request, invoices, contracts, agreements, and meeting scheduling.
  • Facilitate development and manage day-to-day execution of CMC and Technical Operations’ plans, including planning and execution of pre-clinical and clinical raw materials, intermediates, DS and DP manufacturing activities.
  • Plan and manage CMC drug substance and drug product inventory and allocation to support project deliverables including coordinating shipments and import/export activities.
  • Work closely with Chinook program management group, project and launch teams to insure seamless communication throughout the organization.
  • Assist with establishing master contracts and work orders for CMC activity and serve as departmental point of contact for securing internal review and approvals.
  • Develop and apply best practices in the planning, initiation, execution, and closing of projects.
  • Develop and provide consistent project tracking and project reporting to CMC leadership and project teams.
  • Anticipate issues and lead risk assessment processes and review of mitigation plans across projects and programs. Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances, or the overall business relationship.
  • Optimize information distribution and communication to cross-functional study teams.
  • Ensure alignment with cross functional team project managers. Provide clear directions to meet expectations of all stakeholders.
  • Work with team members from clinical development, nonclinical and CMC groups to develop integrated timelines and execute cross-functional operational plans for the project/program.

 

Education, Experience, and Skills:

 

  • Bachelor’s degree or equivalent with 7 years in a life sciences discipline or engineering. Prefer 6 years project management experience within the pharmaceutical industry, with emphasis on pharmaceutical sciences, CMC, product development, related regulatory requirements, and supply chain management.
  • This position requires a broad-based CMC specialist, ideally with experience working in a highly outsourced operating environment.
  • Experience managing external relationships with CMO and CRO partners, central laboratories including RFP processes, budgeting, and supply chain coordination. Ideally, experience will span all stages of development, registration, and commercialization.
  • Strong track record of success in drug development and in understanding cross-functional interdependencies.
  • Successful experience in oversight of global clinical programs and lifecycle required; experience thru NDA/BLA and ex-US equivalent(s) and commercialization strongly desired.
  • Outstanding interpersonal skills and excellent oral and written communication skills including attention to detail and ability to adapt to evolving priorities.
  • Demonstrated critical thinking skills, decision making and problem-solving skills, coupled with the ability to operate autonomously under general direction.
  • Outstanding organizational skills. Strong initiative and desire to work in a fast paced, team oriented dynamic environment and able to reinforce Chinook Culture and improve processes where needed.
  • Proficiency in Microsoft Office suite and other project management tools.

 

Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.

 

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