Seagen

Contract Testing Organization Manager

Technical Operations & Process Sciences - Hybrid Remote, Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

This position provides Quality oversight for Seattle Genetics products testing at Contract Testing Organization (CTO) or Contract Manufacturing Organization (CMO) to ensure compliance with cGMP regulations and quality agreement, including small and large molecules intermediates, drug substance, and drug product.

Serves as the Quality Single Point of Contact (SPoC) for designated CTO(s)/CMO(s) and participate as a key member of CTO/CMO governance teams to enable (as applicable for the testing lab lifecycle stage) site selection and implementation (including due diligence activities), on-going quality supply from testing sites, and/or decommissioning. This position also provides lifecycle management of methods and specifications for designated products tested at the contract organization.

Principal Responsibilities:

• Develop, negotiate and maintain Quality Agreements with CTO/CMO and ensure compliance with agreements.
• Manage all required activities to support testing including approval of protocols, procedures, discrepancies, technical changes, resolution of investigations, CAPA, assessment of change controls, and monitor and report CTO quality performance.
• Hold CTO accountable for maintaining the Specifications and Analytical Methods in a qualified or validated state and compliant with the regulatory dossier, oversee internal data review, complex investigations in partnership with CTO and internal CMC teams, ensure CTO address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, investigation closure, and change implementation with regards to quality and time with the CTO; and escalate as appropriate.
• Provide as needed support during regulatory inspections and cGMP compliance audits, collaborating with CTOs to ensure on time closure of associated CAPAs when requested, act as Quality site manager for contract labs testing Seagen products.
• Collaborate and manage relationships across CTO management and internal governance teams to assure quality expectations are aligned and support joint improvement goals, notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Troubleshoot and direct the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.

Required Qualifications:

• BS/BA or Masters Degree in life science field with 12+ years pharmaceutical QC experience.
• A thorough knowledge and appropriate application of GMPs and other regulations applicable to U.S. and international regulatory agencies.
• Ability to manage multiple, changing priorities in a fast-paced environment.
• Able to work effectively independently with minimal oversight or in a team setting.
• Experience in managing and working with CTOs/CMOs.
• Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential.
• Experience auditing CTO/CMOs desirable.
• Innovative, proactive, and resourceful; committed to Quality and continuous improvement.
• Ability to travel domestically and internationally 20% of time.

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, 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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/20/2022