Seagen’s new cGMP manufacturing facility ‘Launch Pad’ is being built close to Seattle, Washington USA. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs), which broke ground in 2H21 and is expected to be ready for operations in late 2023.

The Quality Sr Specialist / Specialist will be closely involved in the facility design and construction phases, as well as commissioning/qualification/validation (CQV) and start-up planning. The incumbent will join the quality operations team and support systems during the construction and CQV phases to enable on-time successful facility start-up. The ideal candidate has validation and/or quality experience for antibody and sterile drug product manufacturing. Prior experience with a facility start-up is expansion is key, and previous greenfield project experience is preferred. The candidate should also have an established track record for successfully supporting validation activities at clinical and commercial manufacturing organizations. For Sr Specialist, people management responsibility is possible for a limited number of junior staff.

Principal Responsibilities:

• Provide Quality Oversight on validation projects for simple to complex systems and/or projects to assure systems are fit for purpose in GMP operations, including:
• Support customer groups and junior staff by resolving complex technical issues and supporting a range of projects
• Perform impact assessments on and approve system change controls
• Collaborate on or approve validation lifecycle documentation for small to large systems
• Collaborate on or approve system operation, administration, and use operating procedures
• Perform or approve investigations on deviations and incidents in small to large systems
• Lead or participate in the successful completion of cross-functional projects
• Write/revise, review, collaborate on, and approve program or department standard operating procedures; and ensure documents reflect current practices
• Participate as an SME in audits and inspections under the direction of management for Specialist level, as needed
• Represent Quality Systems on cross-functional teams or teams with external parties
• Lead continuous improvement activities that may involve a team
• Make independent decisions within the areas of expertise, with support from management on more complex issues
• Mentor entry-level associates
• Other duties as assigned

Additional Responsibilities for Sr. Specialist:

• Write/revise and collaborate on Quality directives, and approve standard operating procedures that impact multiple departments or programs based on industry best practices
• Participate as an SME in audits and inspections independently, as needed
• Supervise entry-level associates
• Review staff training assignments

Required Qualifications:

• Bachelor's degree in relevant field; or Associate’s degree +2 years of relevant experience in the biotech or pharmaceutical industry.
• Experience with equipment and systems to support manufacturing of biological drug substances and filling of drug product.
• Strong background of cGMP requirements is required, including ability to interpret and apply industry specific guidance documents.
• Familiarity of system validation requirements and industry standards (GAMP and ISPE).
• Experience with cGMP facility start-up (commissioning and qualification).
• Advanced expertise with Office 365, especially Excel.
• Previous experience working with quality management systems (change control, eDMS, event reporting, CAPA).
• Excellent written and oral communication skills.
• Ability to proactively identify and implement continuous improvement projects.
• Demonstrated problem-solving skills and techniques commensurate with job level.
• Ability to manage routine and non-routine workload with little-to-no routine oversight.
• Ability to organize information in a consistent and readily retrievable manner.
• Proven ability to work effectively in a fast-paced team environment.

Required Qualifications for Specialist:

• 5+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry

Required Qualifications for Sr. Specialist:

• 8+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry

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, 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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/01/2022