Seagen

Associate Director/Director Drug Product - Project Launch Pad

Technical Operations & Process Sciences - Bothell, Washington

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 Director, Drug Product Manufacturing Operations 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, manufacturing execution systems, and process engineering to manufacturing staff, and productively collaborate with partner organizations.

Principal Responsibilities:

• Actively participate and contribute to the facility design and operational startup, including, but not limited to, conceptual design, basic design, and detailed design packages and components, process equipment commissioning and qualification, and facility operational readiness activities
• Build and lead a drug product manufacturing team, provide strong leadership and technical expertise to manufacturing operations staff, and productively collaborate with partner organizations
• Implement and maintain required cGMP compliant systems, ensuring operational readiness to produce clinical phase material (phase 1-3) and subsequent commercial/inspection readiness
• Oversee and manage all aspects of cGMP drug product manufacturing, including drug product fill, lyophilization, and packaging
• Productively partner with Product Supply, QA, QC, F&E, MSAT, EH&S, and Finance functions
• Develop and maintain GMP manufacturing and technical documentation including, but not limited to, raw materials specifications, standard operating procedures, manufacturing batch records, bill of materials, job aides, and technical
• Ensure staff GMP training compliance
• Provide technical expertise to lead and close investigations, non-conformances, and corrective actions
• Assist in the generation of relevant regulatory submissions
• Lead staff through internal and external process transfers
• 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

Qualifications:

• Director level – Ph.D. in Engineering or Biological Sciences with 10+ years of relevant experience or B.S. in Engineering or Biological Sciences with 15+ years of relevant experience
• Associate Director level – B.S. in Engineering or Biological Sciences with 10+ years of relevant experience
• In-depth knowledge of equipment, operations, and engineering principles related to biotherapeutic drug product manufacturing, including disposable technologies
• Experience in finished drug product packaging and labelling for clinical use
• 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:

• Fundamental understanding and basic operation of process automation (e.g., DeltaV) and MES (e.g., PAS/X) systems
• Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company
• Experience with finite scheduling tools and allocation of resources and equipment
• Six Sigma certification

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/06/2022