Senior Clinical Supply Specialist

Supply Chain Seattle, Washington


Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. 

Zymeworks is seeking a highly-motivated professional who is looking to grow their career with our company.

About the Position

Zymeworks Inc. is currently seeking a Senior Clinical Supply Specialist to support our global clinical trials. The successful candidate will be part of a highly motivated multidisciplinary group responsible for ensuring that clinical drug supply is available for all clinical sites. Oversite of storage, logistics and temperature monitoring of antibody-based therapeutics and antibody-drug conjugates while ensuring compliance with international regulatory standards.

This senior level role includes clinical planning for phase 1 thru phase 3 studies that includes SOW/contract set-up, managing master label design/proofs, scheduling of pack & label operations as well as leading the monitoring of inventory levels at depots and sites, as well as supporting distribution, temperature monitoring, return or destruction of clinical supply materials.

A background in clinical supply chain practices, as well as a familiarity with applicable cGMP, cGCP and ICH Quality guidelines is preferred. Effective communication and liaising with team members and other groups will be a critical component of daily activities. 

The Senior Clinical Supply Specialist will report to the Senior Manager, Supply Chain and will be based in Seattle, WA. 

Key Responsibilities: 

  • Clinical planning and forecasting of various stage global clinical trials.
  • Manage master label design and proofs for clinical trials.
  • Assist in SOW/contract set-up with clinical packaging vendor
  • Establish and maintain clinical inventory at the depot and site level.
  • Review EBR’s for pack and label operations at the vendor.
  • Monitors domestic and international distribution/logistics for clinical studies, including support of import and export of clinical supplies.
  • Monitors all shipments for temperature excursions and follow up accordingly.
  • Reviews depot and site inventory reports for activity and accuracy and provides these on request to project teams.
  • Requests drug shipments to depots as required.
  • Monitors drug expiration and reviews supply/re-supply settings at clinical sites using IXRS systems
  • Collaborates with the Clinical team and the distribution depot to ensure timely follow up on shipping related issues.
  • Provides support to Clinical Supply Chain, Finance, Clinical and QA on logistics related queries.
  • Supports the Clinical Supply Chain team on department strategy, budget reviews, and general activities.
  • Attends Clinical team meetings and provides updates on supply related topics.
  • Participates as required in the evaluation and selection process for clinical inventory systems (IXRS) in conjunction with clinical operations and other cross-functional stakeholders.
  • Accepts increased responsibility in these specific areas: inventory management, clinical interaction, packaging, labeling and distribution (including cold chain, global import/export and reverse logistics). 

Skills and Abilities:

  • University degree and 5 to 8 years of related experience in clinical or commercial biologics global supply chain management or equivalent combination of education and experience.
  • 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
  • Excellent organizational skills and the ability to work effectively in a high paced, fast-changing environment
  • Experience with IXRS systems is required
  • Experience with clinical drug development process (Phase I-III)
  • Experience with cGMPs and quality standards applicable to temperature-sensitive materials
  • Strong attention to detail and problem-solving skills
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust-building behaviors in all dealings is essential and required
  • Excellent customer-service orientation, a high degree of professionalism, and the ability to work with limited direction
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks
  • Ability to multi-task and shift priorities quickly while working under tight deadlines

Why Work for Us?

At Zymeworks, we stand for innovation, integrity, collaboration and care.

Zymeworks’ employees are passionate, engaged and extremely motivated to succeed.  We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big.  To learn more about Zymeworks Inc. and our current openings, please visit our website at https://jobs.jobvite.com/zymeworkscareers.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. 

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.