Seagen

Principal Scientist, MSAT Drug Linker

Technical Operations & Process Sciences - Zug, Switzerland

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!

Summary: The MSAT Principal Scientist is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support for manufacturing Seagen products manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent is an expert and has deep knowledge of Small Molecule API and Drug Linker manufacturing processes. The Incumbent collaborates with peers from Development functions to ensure a high degree of manufacturability of processes being developed, and will contribute to or lead technology transfers to or between contract manufacturers. The MSAT Principal Scientist will support process validation and GMP manufacturing incl. shop-floor presence and trouble-shooting activities at CMO’s, working closely with QA and QC. The incumbent provides technical and scientific leadership as subject matter expert (SME) relating to manufacturing processes, change control, scale-down/up studies, technology implementation projects and process optimization. The Incumbent collaborates with regulatory CMC and will play an active part in the authoring of CMC sections of submissions and responses.

Requirements or Responsibilities:

• Supporting manufacturing activities for clinical and commercial manufacturing of small molecule API / drug linker at Seagen internal manufacturing sites and CMO’s.
• Providing 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.
• Act as Technical Lead for transfer of processes into manufacturing facilities.
• Support the small molecule API / drug linker throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification).
• Partnering with other functions to apply e.g. modeling 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.
• Providing guidance for root cause investigations of process related deviations in a timely, comprehensive and conclusive manner. Leads the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements.
• Acting as shop-floor support (person-in-plant) during tech transfer, validation studies and commercial manufacturing.
• Develop, optimise and review Master Batch Records and Batch Records during development, clinical supply and transfer to commercial supply.
• Providing guidance for comprehensive facility fit assessments and gap analysis for the relevant part of the GMP manufacturing.
• Working cross-functionally supporting Development and Manufacturing as well as CMO’s in order to prepare User Requirement Specifications (URS) of novel process technologies and facility expansions/modifications to maintain state-of-the-art production meeting business needs.
• Interfacing with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes. Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance.
• Authoring of CMC documents 3.2.S sections, supporting dossier submission and updates as well as responses to health authority questions.

Qualifications:

• Strong scientific and technical experience within relevant development and/or manufacturing technologies and unit operations relating to small molecules. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities.
• Good knowledge of structured methodologies for process design, scale-up/down models, 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.
• Experience working with Contract Manufacturing Organisations is desirable, but not mandatory.
• 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.
• Fluency in spoken and written English is mandatory.
• Experience with innovation and operational excellence is desirable.
• A good understanding of statistical analysis and continuous process verification is desirable.

Education:

Bachelor’s degree in chemistry, chemical engineering, or another relevant life-science discipline with a minimum of 12 years of industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and/or process optimization. Alternatively a Masters’ degree with a minimum of 10 years experience or a PhD degree with minimum 8 years of industrial experience.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/13/2023