Seagen

Downstream Principal Scientist MSAT

Technical Operations & Process Sciences - Bothell, United States

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!

Position Summary:

The Principal Scientist is part of a team of highly skilled scientists responsible for technical and scientific support to manufacturing of Seagen products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent co-ordinates and collaborates with peers from Development functions to ensure new products are robust and well understood. The Principal Scientist will play a leadership role in process and equipment specification, technology transfers, process validation and GMP manufacturing technical support. The incumbent leads process optimization and CMC projects. The Principal Scientist will provide technical and scientific leadership as subject matter expert (SME) relating to downstream manufacturing processes (e.g., purification, conjugation), change control, scale-down/up studies, technology implementation projects and process optimization.

Principal Responsibilities:

• Acts as the primary technical drug substance lead/contact for CMO’s and internal manufacturing sites.
• Provides technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process optimization.
• Works cross-functionally supporting Development and Manufacturing, as well as CMO’s, to introduce robust manufacturing processes.
• Authors and reviews technical reports, manufacturing documents, regulatory submissions, and publications.
• Advises and participates in the assessment and selection of CMOs considering both technical and business elements.
• Specifies and selects key unit operations/manufacturing equipment for new installations.
• Providing guidance for comprehensive facility fit assessments and gap analysis for the relevant part of the GMP manufacturing.
• Partnering with other functions to apply e.g., modelling tools ensuring that scale-down/up and characterization of manufacturing processes is robust and scientifically sound leading to a predictable and highly consistent performance and a well characterized process.
• Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency, and compliance.
• Supports and mentors Scientists and Research Associates.

Required Qualifications:

• Demonstrated expert knowledge in Biologics Drug Substance manufacturing, specifically purification and/or conjugation unit operations.
• Strong scientific and technical experience within relevant manufacturing process technologies and unit operations. Experience of commercial cGMP manufacturing.
• Experience with drafting and review regulatory submissions, responding to agency information requests and fronting agency audits.
• The ability to work effectively and lead small matrix and cross-functional teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams.
• Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seagen.
• The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally.
• Strong communication skills and computer literacy are essential.

Preferred Qualifications:

• Bachelor’s Degree in Chemistry, Biochemistry, Bioengineering, Chemical Engineering, or related field with 10+ years experience of pharmaceutical development and/or manufacturing.Alternatively, a Master’s with 8+ years experience or PhD with 5+ years experience

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.

The hiring pay range for this position is $141,000 to $183,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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: 05/05/2023