Senior Manager, Clinical Supply Chain
Senior Manager, Clinical Supply Chain
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
About the Position
Zymeworks is currently seeking a Senior Manager, Clinical Supply Chain to join our Commercial Operations group. The successful candidate will be part of a highly motivated multidisciplinary group responsible for ensuring that clinical drug supply is available for global clinical trials, including compliance with international regulatory standards applicable to the storage, transport and labeling of antibody-based therapeutics and antibody-drug conjugates.
This role includes demand forecasting, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics including import and export management. This position will also be responsible for leading the clinical labeling and packaging strategy for all materials needed for global clinical studies by working closely with Clinical Operations, CMC and contracted CROs and CMOs to determine manufacturing and supply needs and timelines.
The successful candidate will have a background in clinical and commercial supply chain practices as well as a familiarity with the applicable GMP and ICH Quality guidelines governing biotherapeutics, and the abilty to incorporate multiple variables into forecasts and presentations. Effective communication and discussion with team members and other groups will be a critical component of daily activities.
The Senior Manager, Clinical Supply Chain will be based in Seattle, WA.
- Leads the supply management of all Zymeworks clinical products including demand planning and supply for clinical global studies, management of the labeling and packaging supply chain, and distribution of product to clinical sites.
- Develops strong internal collaboration with stakeholders, including CMC, Clinical Operations, Regulatory Affairs, Quality, and Process Development functions, to ensure effective cross-functional communication.
- Manages clinical packaging and labeling including label design, translation and production.
- Creates and manages a supply plan to support the pharmaceutical product demand forecast, including determination of supply overage amounts and regular inventory updates to project teams.
- Develops supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
- Manages domestic and international distribution/logistics for clinical programs, including import and export of clinical supplies.
- Establishes and maintains Supply Chain department SOPs, including packaging, labeling, logistics and others, in compliance with internal and regulatory standards and requirements.
- Manages external clinical packaging/distribution vendors, including negotiating third-party contracts, and developing the distribution instructions with clinical supply chain vendors.
- Monitors drug expiration and initiates supply/re-supply to clinical sites, serving as the inventory manager.
- Achieves operational objectives by providing information and recommendations to strategic plans and budget reviews, and supporting department budget activities.
- Participates as required in the vetting, evaluation and selection process for clinical inventory systems in conjunction with clinical operations and other cross-functional stakeholders.
- Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained.
Skills and Abilities:
- University degree and a minimum of 8 years’ 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
- Proven experience with forecasting, demand/supply planning, inventory management, clinical, packaging, labeling and distribution including cold chain, import/export and reverse logistics
- Experience in CMO and CRO vendor management
- Working knowledge of the clinical drug development process (Phase I-III)
- Working knowledge of cGMPs and familiar with US and EU regulations and quality standards applicable to antibody-based therapeutics and antibody-drug conjugates
- Strong attention to detail and problem-solving skills, with excellent project management 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, 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?
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 www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
How to Apply
If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.co.uk/jobs/view.php?id=143 . Due to the high volume of applicants, only those selected for interviews will be contacted.