Seagen

Senior Director Bioassay Development

Description

Summary

This position defines and executes overall strategies for bioassay development of clinical and commercial-bound biologic products at Seagen. The position provides strategic oversight for cell-based and biochemical analytical method development, analytical technologies, product characterization, and MoA elucidation for product and process understanding. The position is also responsible for testing services to support high throughput and timely delivery of results to its development client groups. The position interacts with Technical Operations and Process Sciences leadership to shape CMC strategies such as molecule developability, fast first-in-human development, comparability, CQA control strategy, and regulatory submissions, etc., with the end goal of developing and registering biologics products (including ADC) worldwide. This position leads a staff of >25 employees and is responsible for training and developing its next generation leaders.

Principal Responsibilities:

• Drive vision and purpose for the functional area of bioassay development
• Provide strategic oversight and leadership on biologic product development activities, especially bioassay development for control strategy and product characterization
• Collaborate with Research, Non-clinical Sciences and Global Product Team to define mechanism of action for biological products and the consequent control strategy through product development lifecycle
• Define the strategy for critical reagent generation and supply for the functional area
• Lead a high-performing team for bioassay development, provide guidance on design, development, optimization, and qualification of novel bioassays and immunoassays across multiple platforms and technologies (e.g. ELISA, MSD, flow cytometry and cell based-proliferation, phosphorylation, reporter and cytotoxicity assays)
• Ensure adequate resources and technologies are in place to support method development, program support, and fast delivery of high-quality results
• Oversee bioassay method qualification and transfer to Quality Control and ensure assay performance feedback mechanism is in place for continual improvement
• Provide strategic inputs to regulatory submissions, e.g. INDs, BLAs, IMPDs, MAAs
• Develop talent to deepen strength and increase capabilities, aligning with individual career goals. Foster good teamwork and communication amongst staff
• Work with research organization and other development function areas, including Process Development, Analytical Science, Formulation, and Quality. Cultivate excellent working relationship with stakeholders
• Strengthen in-house expertise and laboratory capability. Drive technological innovation to support company’s business objectives
• Motivate team for innovation and operational excellence

Qualifications:

• 15 year of industrial experience in biologics development
• A proven leader in managing and developing talent with diverse skillsets and experience
• A recognized technical leader in the field of bioassay development and biologic characterization
• Excellent understanding of mechanism-of-action for biotherapeutics. Familiar with the regulatory requirements for the safety and efficacy testing of biological drugs
• Experience in IND/IMPD and market registrations of biologics in US and EU. Experience in ROW regulatory regions a plus
• Experience working with collaborators both internal and external partners
• Excellent verbal and written communication skills
• Excellent interpersonal skills
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Demonstrated ability to see beyond own function to understand business issues
• Demonstrated ability to excel in a matrixed and team-oriented environment
• Ability to manage complexity

Education:

• M.S. or Ph.D. in Biological Sciences, Chemistry, Immunology, Molecular Biology, Biochemistry, or related discipline

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/25/2020