Associate Director & Technical Product Steward

Technical Operations & Process Sciences Bothell, United States


Description

Position at Seagen

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 Technical Product Steward 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). This position has responsibility for the technical oversight of Seagen’s global supply network and consequently requires remote leadership and work across different time zones. The incumbent is an expert and has extensive knowledge of Small Molecule API and Drug Linker manufacturing processes and plays a technical leadership and co-ordinating role for the DL/SM API manufacturing process working in close collaboration with MSAT experts. This role partners with the Strategic Product Supply Leader, Internal/External Manufacturing Manager, and the Product Quality Leader ensuring the robustness of the manufacturing process, product quality and continuity of supply. The incumbent leverages knowledge across the organisation and collaborates with peers from Development functions to ensure the robustness of new manufacturing processes. The Technical Product Steward will be accountable for technology transfers to or between contract manufacturers. The Technical Product Steward will support process validation, GMP manufacturing 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 coaches and shares expertise and knowledge across Technical Operations.  

Principal Responsibilities:  

  • Works in collaboration with the Strategic Product Supply Lead (SPSL) to develop and execute Product Supply manufacturing strategies 
  • Accountable for the provision of technical oversight for manufacturing activities for clinical and commercial manufacturing of Drug Linkers/SM API’s at CMO’s. Ensuring that manufacturing process are and remain aligned across manufacturing sites/CMOs 
  • Partners with the Internal/External Manufacturing Manager and the Quality Steward to ensure the robustness of the manufacturing process, product quality and continuity of supply 
  • Provides overall technical leadership for the Drug Linker manufacturing process working in close collaboration with MSAT SMEs 
  • 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 
  • Is accountable for the TechnologyTransfers into manufacturing facilities (internal or external). Review and writes key technical elements of regulatory submissions and responds to agency requests for information 
  • Support the Drug Linkers/AM API’s 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 
  • 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 
  • Advises on Scientific and Business developments (including Technologies, Processes, Products, Input Materials, Regulations etc). Supports Due Diligence activities, CMO selections etc 
  • Coaches and shares knowledge across Technical Operations 

 Qualifications: 

  • Extensive scientific and technical experience within relevant development and/or manufacturing technologies and unit operations relating to SM API/Drug Linker manufacturing. Experience with small and commercial scale equipment utilized in cGMP manufacturing facilities (including clinical manufacturing) 
  • Experience of senior technical leadership 
  • 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 required 
  • 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:  

  • Masters’ degree in Chemistry, Chemical Engineering, or another relevant life-science discipline with a minimum of 15 years of industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and/or process optimization. Alternatively, a PhD degree with minimum 12 years of industrial 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.   

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.   

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 

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