Seagen

Principal Scientist, Conjugation Process Development

Description

Summary:

This position is responsible for leading the conjugation process development (CPD) department, setting up the vision and goal for the department and managing the staff with their career and development growth. This position will also responsible for managing the budget and resources for the department. This position will work very closely with BioProcess and Analytical Science senior leadership in setting up the goals for the broader process development strategies and bringing new and relevant technologies in the process development. The candidate will define and coordinate resources within process development beyond conjugation to accomplish such strategic objectives, as well as drive continuous improvement and develop long-term strategies to build world-class ADCs while maintaining Seattle Genetics leadership in ADCs. The position reports to the Executive Director of BioProcess and Analytical Sciences (BPAS) and interacts closely with Cell Line and Cell Culture Development, Purification department, Pharmaceutical Sciences, Process Analytical, Regulatory and Quality within the Technical Operations organization.

Principal Responsibilities:

• Lead the Conjugation Process Development department within the BioProcess and Analytical Sciences (BPAS) Department, providing technical and managerial guidance to the group.
• Partnering with head of Process Development Head and senior leadership to develop a vision for the group, bring in new technologies, establish and pursue goals for technology development consistent with corporate strategy and manufacturing needs.
• Direct the Conjugation department successfully through early and late stage process development and validation activities.
• Guide the group in designing and implementing phase appropriate processes to support clinical development while balancing speed, quality, and economics.
• Author/review key technical and validation reports, as well as relevant CMC sections to support US and EU regulatory filings.
• Guide the department to tech transfer activities of conjugation processes to SGEN internal manufacturing or contract manufacturing organizations and ensure technical success during manufacturing campaigns.
• Lead the efforts on conjugation front for interfacing with research to deepen scientific understanding of how conjugation process can be developed in manufacturing friendly fashion.

Required Qualifications

• Ph.D. degree in Biological Sciences or Chemical Engineering with a minimum of 8 years or M.S and minimum of 12 years of relevant industrial experience.
• Extensive experience with development of robust conjugation processes and scale up to cGMP environment.
• Extensive experience of leading early and late stage conjugation process development activities including but not limited to Process Characterization and Validation, and deliver with high fidelity, speed and quality.
• Experience of scaling up conjugation processes and working with MSAT and manufacturing with essential knowledge of GMP environment.
• Experience in authoring relevant CMC sections of regulatory submissions and serve as SME in key regulatory interactions.
• Strong management skills and have a proven track record of developing employees.

Preferred Qualifications

• Provide mentoring and staff career development. Foster good communication and team work among staff. Encourage personal growth. Build a reputation for excellence both as an individual and as a group.
• Possession of process engineering skills in areas such as Statistical Experimental Design & Analysis, and process modeling is desired.
• Understanding of process with product quality is essential.
• Demonstrated ability to collaborate and lead cross-functional technical teams
• Must have enthusiasm to work and provide technical and strategic leadership in a team-oriented environment.
• Possess ability to solve problems methodically; able to take initiative and act independently. Must have excellent written and oral communication 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, 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/22/2021