Seagen
Principal/Associate Director Product Quality Leader (Remote)
Technical Operations & Process Sciences - Bothell, Washington
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 is a remote position*
The Product Quality Leader serves as a technical quality expert for the product during clinical development all the way through post-commercialization and is responsible for making quality-related decisions and serving as a liaison between the project team and other quality functions. This role is the single point of contact for all quality issues associated with the development of one or more early/late phase programs. This role is a key member of the CMC sub team, providing efficient and effective strategic and quality input into CMC related activities and associated quality decisions.
Responsibilities:
- Quality single point of contact in the CMC team
- Lead the creation of product specific quality strategy by working across Quality, Technical Development, Manufacturing and CMC Regulatory groups
- Lead Quality Operation team to implement the quality strategy, influence, advice and coordinate strategic and operational efforts across Quality
- Drive product quality risk management, issue identification, resolution and contingency planning
- Responsible for establishing a phase appropriate Quality Target Product Profile (QTPP) & accountable for ensuring the right quality characteristics are implemented
- Responsible for developing a phase appropriate product specification
- Author, review, and own the PQ risk register: identify, communicate, elevate, and document acceptance of risk
- Stay abreast of changes in regulatory standards and expectations as pertaining to product quality
- Author and review CMC regulatory dossier sections and information requests (IND, IMPD)
- Advance operational excellence within Product Quality
Qualifications:
- Full professional proficiency in Chinese Mandarin.
- Principal Scientist level – Requires a minimum of 10+ years’ experience in pharmaceuticals, biologics, or bio-pharmaceuticals, with experience in a quality related role or a product development role.
- Associate Director level – Requires a minimum of 16+ years of experience in small molecules or biologics with 10+ years of experience in a quality related role or a product development role with responsibility for life-cycle management of commercial product.
- 4+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership).
- Technical aptitude and experience in therapeutic drug development, analytical, process or formulation development or product characterization.
- Skilled at guiding technically oriented business objectives within the framework of regulatory guidance and company quality systems, internally and externally, to achieve value-adding outcomes.
- Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership and communication.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment.
Education:
- BS or equivalent in Chemistry, Biology, or a similar life science. Advanced degree is a plus<./li>
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.
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.
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 05/13/2022
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