Associate Director, MES & Process Automation

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: 

Seagen is seeking a highly motivated Associated Director, Manufacturing Execution Systems (MES) & Process Automation that desires an opportunity to significantly contribute to the development and commercialization of transformative cancer therapies. The initial focus of this position will be to actively participate and contribute to the design, build, and operational startup of Seagen’s new clinical and commercial biologics manufacturing facility. This position will also provide strong leadership and technical expertise in process automation and manufacturing execution systems to manufacturing staff, as well as productively collaborate with partner organizations.  

Principal Responsibilities: 

  • Actively participate and contribute to the systems design and operational startup, including, but not limited to, systems implementation, qualification and validation, and facility operational readiness activities 
  • Build, lead, and manage a manufacturing process automation super user and MES teams, providing technical support specific to DS and DP process and equipment control, automation, and MES infrastructure 
  • Partner in technical/process transfers from internal and external sources 
  • Troubleshoot and resolve process automation and MES issues in the field 
  • Liaise with facility & engineering process automation team management to ensure that process automation needs, and requirements are met 
  • Partner with key stakeholders to identify and implement MES domain and functional domain solutions for clinical and commercial manufacturing 
  • Develop and issue cGMP compliant design documents and validation protocols 
  • Translate process requirements into practical usable electronic batch records 
  • Liase with partner organization to integrate MES with external systems such as process control systems, instruments, and other electronic systems (ERP, LIMS) 
  • Develop business processes, guidelines, SOPs, and training for the MES system 
  • Support MES system life cycle, expansion strategy, and business/technical process change management 
  • Provide technical expertise to lead and close investigations, non-conformances, and corrective actions 
  • Assist in the generation of relevant regulatory submissions 
  • Identify process and technology gaps and issues; develop solutions and implementation plans 
  • Participate and support internal and regulatory authority facility audits and site inspections 
  • Assist in the generation, tracking, and adherence to Capex and Opex budgets 
  • Provide strong leadership, guide, and mentor staff to ensure productive and collaborative organizational performance and individual career growth 

Required Qualifications: 

  • B.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 10-15+ years of relevant experience 
  • Advanced understanding of process automation (DeltaV) used for bioprocessing controls systems 
  • Expertise in MES systems deployment, configuration, integration, and validation 
  • Extensive knowledge of GdPs, cGMPs, and regulatory requirements including 21 CFR Parts 210 and 211, and ICH Q7 
  • Exceptional leadership skills to thoughtfully guide teams and individuals  
  • Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical leadership to individuals within the team 
  • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and teamwork 
  • Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making 
  • Capacity to develop solutions for technical issues of difficult scope 

Preferred Qualifications: 

  • Previous experience in computer software validation partnering with IT and QA 
  • Expertise using GAMP5 guidelines for risk-based approach to computer system validation  
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards 
  • Proficiency developing and executing CSV plans and protocols 
  • Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company 

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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