Seattle Genetics
Sr. Manager, Clinical Packaging Operations
Manufacturing & Supply Chain - Bothell, Washington - San Francisco, California
Description
Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
Summary
Responsible for the management of global clinical supply for Seattle Genetics clinical programs. Expected to have extensive knowledge across many functional areas and resources related to global clinical supply operations. Includes oversight of Packaging and Labeling CMO(s), scheduling (international & domestic production/packaging), companion and comparator drug sourcing, analysis and reporting of production performance, analysis of clinical supply/demand trends, and creation and implementation of clinical product packaging.
Responsibilities:
- Reviews and interprets clinical study protocol design and determine study labeling requirements and develops master project plans.
- Works closely with all internal and external resources to optimize clinical supply availability and inventory investment.
- Works closely with the Clinical Inventory and Production Planner to:
- Collect and analyze inventory information from vendors for the planning of clinical drug product.
- Clinical Study Drug Forecast.
- Assist the Clinical Production Planner 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.
- Initiates clinical Finished Drug Product carton and label design, including blinded kit packaging and randomization schemes.
- Provides periodic study status reports on clinical drug product inventories, and planned production to Sr. Management, CMC and Clinical Operations Teams.
- Recommends changes to labeling/packaging schedules based on study progress and or any changes with the study plans.
- Develops and communicates accurate lead time requirements to the packaging and labeling and distribution CMOs, as well as the internal Seagen teams as required.
- Acts as point of contact for third party CMOs and Comparator Sourcing suppliers.
- Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish the program’s goals.
- Leads the clinical supply module set up, supports implementation and maintains the inventory management functionality of the IWRS/RTSM systems.
- Liaison between the CMC and the Clinical Operations teams and attends team meetings as required.
- Supports Seagen’ systems implementation, reports and SOP creation as required.
- Experience managing direct reports.
Qualifications:
- A minimum of 8+ years working in a global biopharmaceutical Supply Chain or related industry.
- Have an in-depth functional knowledge of Clinical Supply Operations.
- Experience in Phase I to Phase III global clinical study rollouts in a Clinical Supply leading role.
- Demonstrated knowledge of Clinical labeling regulations/requirements and best practices.
- Minimum of 8 years supervisory and production planning experience within a manufacturing environment.
- Experience and knowledge of cGMPs in a FDA regulated environment.
- Experience working within an integrated enterprise level planning system. (Oracle).
- Ability to travel 20%.
Education:
- BS/BA Degree in a business or supply chain field.
- APICS (CPIM and/or CIRM) certification or active pursuit of.
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Apply:
Seattle Genetics
Seattle Genetics is an Equal Opportunity Employer
Submitted: 01/11/2019
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