Seattle Genetics

Head of Analytical Sciences

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

The Head of Analytical Sciences reports to the VP of Biologics Development and Clinical Manufacturing and will lead a staff of >25 employees. This position will be responsible for training and developing its next generation leaders and will define and execute overall strategies for analytical development of clinical and commercial-bound biologic products at Seattle Genetics. It provides strategic oversight for analytical method development life cycle, analytical technologies, product characterization, and molecular/structural elucidation for product and process understanding. The position is also responsible for analytical testing services to support high throughput and timely delivery of results to its development client groups. This position interacts with Technical Operations and Process Sciences leadership to shape CMC strategies such as molecule developability, fast first-in-human development, manufacturing technologies, comparability, CQA control strategy, and regulatory submissions, etc., with the end goal of developing and registering biologics products (including ADC) worldwide.

Responsibilities:

• Develop talent to deepen strength and increase capabilities, aligning with individual career goals. Put in place succession plans for key leaders. Encourage personal growth. Foster good team work and communication amongst staff. Build a reputation for excellence both as an individual and as a team.
• Lead and oversee all facets of analytical development, including early molecule developabilty assessment, technology innovation, method development, transfer and lifecycle management, comparability, product characterization, molecular and structural elucidation, and analytical testing services.
• Provide strategic leadership to analytical testing services to ensure adequate resources and technologies are in place to support high throughput processing, and accurate and fast delivery of results.
• Drive technological innovation in all aspects of analytical development to support company’s business objectives.
• Collaborate with process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
• Establish control strategy approaches that enable fast entry to IND with sufficient product knowledge to also allow moving quickly into late stage/commercial development and product characterization.
• Oversee method qualification and transfer to Quality Control.
• Oversee relevant CMC sections of regulatory submissions and serve as a subject matter expert in regulatory interactions.
• Support manufacturing activities at both internal and external manufacturing organizations. Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
• Collaborate with Research to bring new molecules into process development. Deploy resources intelligently to perform at-risk development activities prior to development decision.
• Invest resources to advance our understanding of relationship between process and product quality.
• Set example of scientific and operational excellence for the department and lead department to achieve it. Set objectives and metrics for continual improvement on best practices.
• Represent department to the company. Propose recommendation and solution to challenges facing the organization.
• Mentor functional area representatives to achieve CMC/GPT team objectives.
• Collaborate effectively with departments within and outside of TOPS organization.
• Serve as a member of Specification and Technical Development Committees.

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.
• Must have practical working knowledge of cGMP; capable of assessing compliance to quality requirements using sound judgment and decision-making skill.
• 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.
• Strong analytical skills and ability to distill key information from various data sources.

Education:

• Ph.D in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field.

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.

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Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 11/30/2018