Seagen

Senior Principal Scientist, MSAT Technology Transfer

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 Senior Principal Scientist MSAT Technology Transfer is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of all Seagen products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent is a member of the MSAT Leadership Team and is an experienced scientist with extensive Project Management and Technology Transfer knowledge and experience. This role leverages expertise and knowledge from SME’s and partners within Development, Manufacturing and our CMO network. The incumbent will lead a team of Technology Transfer Leaders who are responsible for technology transfers of Drug Substance, Intermediates, Drug Products and Packaged Products from Development to Commercial manufacturing and between commercial manufacturers, both internal and external. This position supports Seagen’s global supply network and will include remote leadership and work across different time zones. The position will ensure the development and implementation of robust technology transfer processes, as well as the efficient transfer of product and process knowledge, manufacturing processes and technologies between sending and receiving units/sites. The incumbent will lead/manage cross-functional matrix teams to deliver Technology Transfer projects. The incumbent will strive to standardise Technology Transfer practices and to continuously improve associated processes, tools and templates. The incumbent shares Technology Transfer tools and expertise across Technical Operations and Technical Development.

Principal Responsibilities:

• Manages and leads a specialized team of Technology Transfer Leaders who lead technology transfers across the Seagen network (internal and CMO sites).
• Develops and implements robust technology transfer processes.
• Develops and implements Technology Transfer Strategies in collaboration with the Strategic Product Supply, Process Sciences, Manufacturing and Quality.
• Lead Technology Transfer discussions and secure agreement with the sending and receiving units (both internally and externally with contract manufacturers).
• Lead Technology Transfers by driving matrixed, cross-functional teams to ensure successful PPQ and production campaigns (clinical, validation and commercial campaigns). Enabling the successful achievement of key CMC milestones such as product launch.
• Lead and manage Technology Transfer activities from development (clinical and commercial products) into commercial manufacturing and testing facilities (internal and external).
• Lead and manage Technology Transfer activities within the commercial supply and analytical testing network (between commercial suppliers or the introduction of a new supplier).
• Develop and manage Technology Transfer project plans (detailed and high level milestone plans) based on information from all participants/stakeholders. Carry out regular risk reviews and develop mitigation plans to address risks and constraints.
• Negotiate, secure and manage resources (human and financial) for Technology Transfer projects.
• Develop, in conjunction with key stakeholders/project team/s, Technology Transfer communication plans and metrics.
• Lead and leverage SMEs and resources to ensure the successful definition and completion of the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification). CPV plans implemented as part of the TT.
• Lead, manage and resolve project constraints and risks.
• Proactively update and inform Senior management (and within external forums as appropriate) of milestone progress and any potential project risks or delays.
• Lead and manage the capture and transfer of knowledge between companies, sites and functions as an integrated part of the Technology Transfer process.
• Lead improved process and facility capability, process scale-up and improved understanding and control as part of the Technology Transfer.
• Shares and educates TOPS functions on Technology Transfer practices and
• Leads and manages TT resource plans and Monthly TT.

Qualifications:

• Extensive Project Technology Transfer experience within Pharma (Biologics preferred)
• Line/team leadership experience (including remote leadership) of collaboration with Contract Manufacturing Organisations.
• Excellent project management and matrix people management skills.
• Proven track record in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decision in the pharmaceutical industry.
• Excellent verbal and written communication skills (fluency in English is mandatory).
• Good knowledge of structured methodologies for process design, process control strategies, process validation and continuous process verification.
• The ability to work effectively in small matrix 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 management and technical staff within and outside of Seattle.
• The candidate must demonstrate high levels of integrity. Key competencies are management of plans, complexity, driving for results, problem-solving and collaborating cross-functionally.
• Strong communication skills and computer literacy are essential.
• Experience with innovation and operational excellence is desirable.
• Thorough understanding of local compliance, as well as a sound ethical approach to business.

Education:

• Bachelors’ degree in engineering, pharmaceutical sciences, or another relevant life-science discipline with 10+ years of industrial experience in Technology Transfer/Project Management within Pharmaceutical Development and/or Manufacturing.
• Alternatively a Masters degree with 9 years of experience or a PhD with 8years of experience.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/24/2023