Seagen

MSAT Senior Scientist Drug Product Biologics

Technical Operations & Process Sciences - Zug, Switzerland

Description

Seagen is a global multi-product biotechnology company that develops and commercializes innovative 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 four marketed products, 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. More information about Seagen can be found at www.Seagen.com.

Position Summary:

The MSAT Sr. Scientist is part of a team of highly skilled scientists responsible for technical and scientific support for manufacturing of all Seagen products, whether manufactured internally or at contract manufacturing organizations. The incumbent collaborates with peers from Development functions to ensure a high degree of manufacturability of the processes being developed and will contribute to or lead tech transfers. The Sr. Scientist will support process validation and GMP manufacturing including troubleshooting at CMOs while working closely with QA and External Manufacturing. The incumbent provides technical and scientific leadership as a subject matter expert relating to manufacturing processes, change control, scale-down/up studies, technology implementation projects, and process optimization.

Principal Responsibilities:

• Responsible for drug product manufacturing technical support for internal or external manufacturing. May take lead role
• Provides technical support for clinical or commercial stage programs, including sub-team representation
• Provides guidance for root cause investigations of process related deviations, including CAPA design and implementation
• Authors and reviews technical reports, manufacturing documents, regulatory submissions, and publications
• Leverages literature, ICH/regulatory guidance, and practical experience to perform their work and influence CMC strategies
• Provides person-in-plant manufacturing oversight
• Recommends and implements new technology that advances knowledge and productivity within the department
• Presents at department, project team, and senior management meetings. May present externally at scientific conferences

Required Qualifications:

• Scientific and technical experience within process development or manufacturing
• Motivated with the ability to work independently as well as on cross-functional and cross-site teams
• Strong communication skills and computer literacy are essential
• Fluency in spoken and written English is mandatory
• Detail oriented, strong organization and time management skills
• Creative problem solver willing to troubleshoot and establish new protocols

Education:

• B.S. and 7+ years; M.S. and 5+ years; Ph.D. and 2+ years

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/18/2023