The Principle Scientist / Engineer, Tech Transferis 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 an experienced scientist with extensive Technology Transfer knowledge and experience. This role leverages expertise and knowledge from SME’s and partners withinDevelopment, Manufacturing and our CMO network.
The incumbent will lead and manage technology transfers of Drug Substance, Intermediates, Drug Products and Packaged Productsfrom 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 Principle Scientist / Engineer, Tech Transfer will ensure the robust and efficient transfer of product and process knowledge, manufacturing processes and technologies.
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.
Principal Responsibilities :
Develop and implement Technology Transfer Strategies in collaboration with the Strategic Product Supply Lead,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, secureand 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,processscale-up and improved understanding and control as part of the Technology Transfer
Develop, standardize and share Technology Transfer practices and procedures
Build a standardized approach and continuously improve tools / templates used for Technology Transfer project management across Seagen
Lead and manage MSAT Monthly Reporting
Perform After Action Reviews and facilitate lessons learned
Extensive Technology Transfer experience within within Biologics Pharmaceutical Development or Manufacturing (internal and external Technology Transfers)
Experience of collaboration with Contract Manufacturing Organizations
Excellent project management and matrix people management skills
Proven track record in generating technical options to resolve problems, prioritizing solutions, selecting optimal solutions and implementing decisionin 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 environmentwith changing priorities and ahigh 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 ofSeagen
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
Bachelors’ degree in engineering, pharmaceutical sciences, or another relevant life-science discipline with12 years of industrial experience in Technology Transfer / Project Management within Pharmaceutical Development and / or Manufacturing.
Alternatively a PhDor Masters degree with 9 years of experience
As a leading employer in our industry, 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.