Seagen

Head of Process Development Small Molecule

Summary

The Head of Process Development, Small Molecules will serve as the leader for Process Chemistry, Process Engineering and Analytical Chemistry functions. This organization is responsible for synthetic route selection, development, scale-up, optimization and transfer of processes and methods to our Contract Development and Manufacturing Organizations, right first time, every time. In this context, members of this organization are actively engaged with their counterparts in Discovery Chemistry, process chemists in the route screening, selection and development of new synthetic routes in order to ensure that we deliver reliable and sustainable commercial manufacturing processes of synthetic drug substances throughout all clinical phases until transfer to commercial manufacturing. In addition, this group is also accountable for evaluating and leveraging appropriate technologies and methodologies, such as flow chemistry, computational chemistry, computational fluid dynamics, process analytical technology, design of experiments and Quality by Design to increase speed to market while delivering a robust manufacturing process with increased process understanding.

The Small Molecules, Process Development group is a part of the larger Technical Operations organization, the mandate for which is to reliably deliver the pipeline and ensure the resilient supply of products. Our organization aspires to be recognized in the industry for being the best in drug-linker science, chemistry and manufacturing technology.

Principal Responsibilities

• Responsible for developing and implementing the strategy, for advancing the technological capabilities and competitiveness of SeaGen in small molecules, drug-linker chemistry, analytical chemistry and manufacturing technologies. Be aware of technology and global regulatory trends in the industry and use this understanding to identify and build leading edge capabilities within the Small Molecules, Process Development organization.
• Responsible for building and leading multiple senior-level scientists, engineers, and technologists, including, Senior Director and Director level staff. Develop & nurture core competencies of the process development SMEs to ensure technical capabilities are built and that knowledge and experience are maintained.
• Foster process understanding by applying principles of Quality by Design to drug substance development to deliver cost efficient, robust processes while ensuring business continuity and compliance with quality and global regulatory requirements.
• Partner with peers within the Discovery Chemistry, Process Development and Process Sciences organizations to develop and implement a stage gate process for new product introduction in order to ensure we successfully and consistently deliver drug-linkers of desired quality.
• Collaborate with peers in Process Sciences, External Supply and Manufacturing, Quality and Regulatory Affairs organizations, to support successful development, registration, and commercialization of pipeline.
• Partner with the External Supply and Quality Organizations in CDMO selection and Audits.
• Partner, as appropriate, with MSAT and Quality in resolution of complex technical issues impacting supply.
• Partner closely with peers in Legal, Discovery Chemistry and Process Development to develop and implement strategies to protect intellectual property.
• Ensure the timely delivery of the project portfolio of by effectively assigning resources – people and budget, setting priorities and providing a robust framework for decision making and problem solving. Effectively communicate progress against mileposts to internal and external stakeholders.
• Ensure proactive compliance to all regulatory, safety and environmental regulation and expectations.
• Review and approve all regulatory submissions.

Qualifications:

• 15+ years experience within the bio-pharmaceutical industry.
• Proven track record as a leader in building high performance technical organizations.
• In depth knowledge of all phases of drug development and commercialization with a specific focus on synthetic organic chemistry, process sciences, process engineering, analytical technology, design of experiments, quality, compliance and applicable regulatory requirements.
• Excellent communication skills and a strong ability of building and maintaining constructive and effective relationships with internal and external stakeholders as well as strong collaboration and team building skills across cultures, countries, technical competencies, and organizational levels.

Education

• A Doctorate Degree in Organic Chemistry or Chemical Engineering / Technology discipline.

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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/31/2020