Manager, Supply Chain

Company Description
Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop antibody-based therapeutic candidates. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA. 

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite.

What You'll Do

• Serve as the primary clinical supply chain contact, working collaboratively with internal stakeholders (ie. TMO, Clinical Operations, etc.) and external partners.
• Manage clinical supply planning and forecasting for study protocols.
• Support financial planning for global clinical supplies (including budgeting, forecasting, and strategic planning activities for clinical trials).
• Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategies.
• Monitor global clinical supply inventory at the clinical site level for both IVRS and studies by tracking of specific milestone dates and adjusting drug distribution accordingly.
• Monitor IXRS portal processes including high and low enrolling site settings, drug acknowledgement, depot and site supply levels, and IMP status of released lots or expired drug.
• Coordinate the origination, proofing and translation of clinical study labels, as required.
• Coordinate drug supply delivery timelines with Clinical, packaging suppliers, drug depots, etc.
• Maintain close communication with team members (ie. manufacturing, clinical, regulatory) to ensure the adequate supply of clinical supplies throughout the duration of all clinical trials.
• Serve as member of clinical study team by participating in the design of study plans, protocols, IB’s, etc.
• Manage third party packaging/labeling, and logistics suppliers.
• Provide reports on available inventory, and updates expiry date/shelf life extensions at the depot.
• Facilitate the development, negotiation, and approval of formal quotations and proposals; work orders; purchase orders; etc.
• Proactively coordinate with manufacturing, clinical, regulatory and QA departments to establish appropriate production plans and timing for P&L based on fill/finish release dates, regulatory requirements and the drug demand forecast.
• Coordinate timely material release with Regulatory and QA functions.
• Design labels to ensure regulatory compliance with US, Canada, EU, APAC regulations, as appropriate. Work with Clinical, Regulatory, QA, and Manufacturing to develop Master Label text and arrange translation services as required.
• Establish appropriate packaging and labeling schedules, including appropriate contingency plans to support unanticipated demand shifts and potential supply shortages.
• Coordinate with QA on the review and approval of all documentation associated with labeling of investigational supplies (e.g., label proofs, packaging and labeling specifications and methods, packaging batch records).

What You'll Bring

• 5+ years’ related clinical supply management experience in cGMP and GCP Ph I-III studies (Supply Chain Management Association accreditation as a Supply Chain Management Professional (SCMP) a plus).
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.