Seagen

Manager Manufacturing Compliance - Launchpad

Technical Operations & Process Sciences - Bothell, United States

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:

Seagen is seeking a highly motivated Manager, Manufacturing Compliance, 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 cGMP manufacturing facility, “Project Launchpad” that is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs). This position will also provide strong leadership and compliance expertise to manufacturing operations staff, and productively collaborate with partner organizations.

Principal Responsibilities:

• Actively participate and contribute to the plant operational startup, including and not limited to, process equipment commissioning and qualification, GMP documentation and training, facility operational readiness activities, and commercial compliance.
• Provide manufacturing compliance oversight of GMP manufacturing and warehouse areas at the Everett Manufacturing facility; develop and evaluate manufacturing equipment, systems, and operations gaps and lead refinements; ensure manufacturing compliance to written procedures; drive ongoing improvements to ensure GMP compliance, and audit/inspection readiness.
• Review and approve complex and foundational Standard Operating Procedures specific to the manufacturing facility, including but not limited to, New Product Introduction; Area and Equipment Change Over; Cleaning Validation & Verification; Personnel, Materials and Waste Flow; Facility Disinfection, etc.; present and defend during audit/inspection.
• Perform manufacturing compliance oversight of the GMP manufacturing areas at the Everett Manufacturing facility. Evaluate manufacturing equipment, systems, procedures, and operations for gaps; facilitate modifications and best practices to ensure manufacturing compliance to written procedures and regulations; drive ongoing improvements to ensure cGMP compliance and audit/inspection readiness.
• Partner with the Manufacturing and Quality Operations groups acting as a liaison ensuring alignment with quality directives and promoting internal manufacturing best practices and improvements to facilitate manufacturing readiness for internal and external quality audits/inspections.
• Participate directly in internal, external, and global health authority audits/inspections of the Everett Manufacturing Facility. Provide support during external regulatory audits/inspections and work closely with the audit team to respond to audit requests and facilitate successful inspections.
• Work cross functionally to develop and implement content for a comprehensive training program to include knowledge and performance assessments for the qualification of manufacturing personnel. Support Quality Training groups in ensuring manufacturing training curriculum and content is appropriate and up to date. Present and defend the training program during audits/inspections
• Provide support to the Manufacturing Operations group on significant deviations, CAPAs, change controls, and impact assessments. Also, provide mentorship and training along with the development of templates for generating consistent, high quality write-ups/investigations for less significant deviations, CAPAs, and change controls
• Utilize Quality Risk Management and Operational Excellence principles to assist in risk-based decision making and drive continuous improvement for internal manufacturing. Participate in risk assessments associated with the Everett Manufacturing facility and assist in presenting and defending risk assessments during audits/inspections.

Expected Qualifications:

• High School Diploma / Associates Degree with exposure to science & math coursework
• 8+ years of relevant biopharmaceutical industry experience 4+ years of direct manufacturing or quality experience with cGMP production of biologics
• 2+ years of supervisory experience managing direct reports cGMP audit experience
• Recognized as a knowledgeable resource on a range of compliance topics Demonstrated strong knowledge of cGMPs for drug substance manufacturing of biologics
• Demonstrated ability and experience working in cross-functional teams supporting biopharmaceutical manufacturing
• Demonstrated organizational and leadership skills with regard to project management with the ability to influence and engage indirect reports and peers
• Able to work equally well as part of a team or independently
• Excellent technical writing skills
• Excellent oral and written communication skills
• Skills in problem solving and troubleshooting
• Proficient with MS Office suite (Word, Excel, PowerPoint)

Preferred Qualifications:

• BA/BS degree in a scientific discipline (life sciences / engineering) Knowledgeable of applicable business systems including: ERP, QMS, LIMS, MES, and PAS
• Previous experience with single use technology in the biopharmaceutical 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, please visit www.seagen.com.

The hiring pay range for this position is $116,000 to $149,600 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/10/2023