Seagen

Director, Development Quality Control

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

The Director, Development Quality Control (QC), is responsible for setting strategic direction for functional unit to successfully support clinical product development. This position is responsible for managing delivery of QC deliverables in support of clinical products, oversight of QC testing and product stability strategy development and QC activities to fulfill control strategies, such as method transfer, method validation, product reference certification, product specification setting and implementation to support cGMP manufacturing, supporting regulatory filings and interactions with health authorities.

Responsibilities:

• Provide leadership, vision, set strategic and tactical direction to the Development QC Group in the cGMP environment
• Manages the employee performance process and career development for the team
• Develop their own and team’s goals and milestones to meet QC targets for clinical development programs
• Build the team to achieve clinical product development goals through collaboration with internal stakeholders and external partners
• Recruit, retain and develop QC staff to support all clinical products development
• Serves as a leader and member in Global QC Leadership Team
• Sustain employee engagement by creating a culture of excellence and an environment in which individuals and teams can excel and continuously improve
• Develop and maintain strong and effective relationships and trust with key stakeholders to understand strategy and future needs
• Lead team and provide oversight for clinical product investigations and reports in response to OOS/OOE/OOT
• Oversee authoring and/or review assigned CMC sections for new and amended IND/IMPDs and license applications (BLA/NDA/MAA)
• Make decisions around complex issues associated with sub-function/area of expertise that may impact key program and/or inter-department processes
• Collaborate with Global Quality, development functions (i.e. Analytical Sciences, Pharmaceutical Sciences, Supply Chain, etc.)
• Define and manage expense budget planning and project resourcing schedules
• Influencing the external scientific/regulatory community through participation in external activities and conferences

Qualifications:

• Bachelor’s degree in life science (post-graduate degree in a related field is a plus) in biology, biochemistry, or any related technical discipline
• A minimum of 10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required (recommended 18+ years overall relevant experience)
• A minimum of 7 years in direct supervision of laboratory staff or project management. Experience in conducting lab investigations on biological molecule
• The ideal candidate for this position will have demonstrated in-depth experience of managing QC development functions associated with the cGMP production and control strategies of biologic products in clinical settings
• This individual should have an in-depth knowledge of Antibody Drug Conjugates (ADC) or monoclonal antibody product development and test methods applied for cGMP testing
• Hands-on experience with managing method transfer/validation, product reference selection, certification and lifecycle management, product specification setting and implementation, stability study design for drug substance and drug product
• Strong QC mind-set with extensive knowledge of regulatory expectations for clinical product development and experience of cGMP’s
• Strong planning and organization skills, ability to establish and manage multiple competing priorities and proceed with objectives with minimal supervision
• Highly collaborative with outstanding relationship building skills
• Adept at leading people, mentoring, and developing other leaders within the group
• Excellent communication skills
• Experience with phase appropriate cGMP development environment

Preferred Qualifications:

• Hands-on QC testing experience with biologics (including ADC), aseptic products (both liquid and lyophilized forms)
• Demonstrated experience in successfully leading QC teams in a matrix environment to deliver strategic vision
• Strong project management skills and experience managing multiple projects at the same time is essential
• Demonstrated excellence in written and verbal communication
• Demonstrated ability to work cross-functionally and develop strong business partner relationships in a matrix-environment across organizations
• Ability to manage and lead in a fast pace and high change environment
• Strong technical writing skills

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