Associate Director/Director Validation

Product Supply Operations Bothell, Washington


Description

Summary:

The Product Supply Validation Leader is part of the technical leadership team tasked to enable and support to the manufacture of all Seagen products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent is recognized expert and has extensive industry knowledge of Validation and plays a pivotal leadership and management role in the end-to-end validation process. This role leads and oversees Product Supply’s facility, equipment and process validation programs and partners with IT in the Computer Systems Validation (CSV) for manufacturing processes, equipment & facilities. The Validation Leader develops global strategies and standards to ensure manufacturing facilities and processes are validated and maintained in a state of compliance with applicable cGMPs, global health authority regulations and industry standards. The Validation Leader partners with Manufacturing, MSAT, Development/Process Sciences, Quality, IT and Regulatory and EHS to manage the development of the master validation plans, their execution and lifecycle management. 

Responsibilities:

  • Provides technical oversight of validation systems, standards and documentation supporting new drug applications, product launches, technology transfers, facility and equipment modifications/upgrades, and modifications to existing formulations and processes
  • Utilizes a risk-based approach to develop and maintain compliant, and cost-effective systems and procedures. Develops and supports procedures including Statistical Process Control and Continued Process Verification to enable robust and compliant manufacture
  • Collaborates with IT and Quality to ensure the validation of computer systems used across GXP operations is conducted in compliance with applicable regulatory requirements and internal procedures
  • Manages and leads a specialized team of validation engineers which provides validation advice, expertise, and services for Seagen’s internal manufacturing network (North Creek and the new Launchpad site) and external CMO network
  • Provides technical direction and guidance to all staff involved in validation activities (facility, equipment, process, CSV and cleaning)
  • Interfaces with collaborates with Development/Process Sciences, MS&T SME’s, Manufacturing and QA teams to develop robust systems for identifying, challenging, qualifying, and trending Critical Process Parameters, Critical Quality Attributes, Control Strategies, and Sampling and Testing Plans
  • Builds and maintains expertise in validation and related activities. Acts as a Seagen wide leader and SME in discussions and communications with regulatory agencies including activities associated with regulatory submissions and facility inspections
  • Reviews and provides guidance on proposed changes to validated processes via CAPA and Change Controls to assess risk and identify requirements necessary to maintain a validated state
  • Assists with the development of Standards, Guidelines and SOP’s to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes
  • Works cross-functionally supporting Development and Manufacturing as well as CMO’s to develop validation plans and approaches, including novel process technologies and facility expansions/modifications to maintain state-of-the-art production capability
  • Coaches and shares knowledge across Technical Operations
  • Mentors, trains, and develops future leaders in validation and associated disciplines

Additional Responsibilities at Director level:

  • Leads, develops, and implements the Product Supply’s Global Validation strategies, policies and procedures based on current regulations, industry standards and best practices (leads decision making on validation)
  • Leads and oversees Product Supply’s facility (building, utilities, and services), equipment and process validation programs
  • Leads, develops, and executes, through his team, validation master plans for new manufacturing facilities/capacity (specifically Launchpad Project – Seagen’s second internal manufacturing facility)

Qualifications:

  • Extensive technical knowledge of validation and current validation approaches and practice
  • Validation Leadership experience (team leadership, functional or discipline leadership)
  • Extensive knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations, and standards
  • Experience in the management of Quality systems
  • Proven track record with successfully managing validation programs in support of GxP Operations (Facility, Equipment and Process)
  • Experience of fronting regulatory inspections on validation
  • Experience with validation of API, OSD, Parenteral and Biologics formulations and facilities
  • Experience with Sterile facility (clean room (ISO 8), water for injection, other support utilities etc.) validation
  • Experience of facility, equipment, process, cleaning, computer systems validation and continuous process verification
  • Experience of multi-site/global validation leadership
  • Experience working with Contract Manufacturing Organizations
  • Good leadership skills and ability to influence and work across organizational boundaries
  • 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 technical staff within and outside of Seattle Genetics
  • 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
  • A good understanding of statistical analysis and continuous process verification is desirable 

Education:

  • For Associate Director level: Masters’ degree in pharmaceutical science or another relevant life-science discipline with 15 years of industrial experience in validation practices and approaches. Alternatively, a PhD degree with 12 years of experience
  • For Director level: Masters’ degree in pharmaceutical science or another relevant life-science discipline with 18 years of industrial experience in validation practices and approaches. Alternatively, a PhD degree with 15 years of 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.


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