Manager Clinical Supply Chain Packaging Operations
Seattle Genetics is seeking a highly motivated candidate to join our team and be responsible for planning and management of our global, clinical supply. The ideal candidate will be able to determine supply requirements by reviewing the clinical protocol and will convert the requirements into a supply plan using project management techniques. This individual will work closely with internal/external teams on the supply plan to ensure it meets the deliverables of all parties. As a Clinical Packaging Manager, the candidate will be expected to oversee complex, clinical trials where they can draw upon their experience to develop the most effective solution to meet the clinical trial needs and timelines.
- Collect and analyze inventory information from vendors for the planning of clinical drug product
- Assist with the lot information and tracking of inventory by study by country
- Monitor the inventories of clinical product, including comparator drug at the distribution points
- Prepare and distribute periodic status reports on clinical drug product inventories, and planned production
- Provides timely and accurate clinical inventory information to the required systems
- Assist in the maintenance of the IWRS/IRT inventory database
- Recommend changes to labeling/packaging schedules for SGEN clinical drug products based on progress
- Provide liaison between SGEN teams and the Clinical Operations group
- Develop and communicate accurate lead time requirements to our packaging/distribution vendors as well as the internal SGEN teams as required
- Manage the development of packaging plans/schedules and track/report against actual performance
- Acts as point of contact for third party vendors
- Experience in a FDA regulated atmosphere
- Maintains continuous education in work related field
- Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential
- Experience working with an enterprise level planning system. (SAP, Oracle etc.)
- Skilled clinical packaging and labeling (primary and secondary) operations/project management of small molecules and biologics
- Ability to travel ~ 10%
- BS/BA Degree in a business field and/or a minimum of 5+ years of product supply or manufacturing operations experience
- Minimum of 5+ years planning experience within a manufacturing environment or 3 years being in a pharmaceutical or process industry setting
- APICS certification desired
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.