Job Detail

Description

Summary:

We are currently seeking a Manager to join our External Manufacturing Operations team based in our European subsidiary site in Zug, Switzerland.  The position will support production efforts at Contract Manufacturing Organizations (CMOs) throughout Europe, with an emphasis on antibody-drug conjugates (ADCs).   

Responsibilities:

• Understand Seagen’s drug substance and drug product manufacturing processes and provide technical support, as needed


• Perform technical review of master and executed batch records, specifications, deviations, and change requests and manage timely implementation to ensure drug supply


• Monitor and maintain positive business relationships with CMOs to encourage collaboration, transparency, and accountability


• Facilitate internal and external discussions to identify, address, or escalate technical or business challenges


• Provide onsite support, as needed, at CMOs to ensure overall compliance, appropriate resolution to critical issues, and timely progress updates

 
Qualifications:

• Degree in biology, chemical engineering, or other Life Science with 7+ years relevant experience in biotechnology or pharmaceutical industry


• Demonstrated proficiency in biologics manufacturing to cGMP standards including knowledge of regulatory guidelines and product lifecycle management


• Expertise in biologics or parenteral drug product manufacturing highly desirable


• Experience working with CMOs on a broad range of projects including support of commercial and/or clinical manufacturing in a GMP environment


• Experience working in global project teams, leading and motivating cross functional teams in a matrix management environment or multi-site organization


• Excellent interpersonal skills, including a positive and constructive attitude, and the ability to build effective relationships and teams


• Flexible and proactive nature and can adapt to changing priorities as needed


• Ability to travel within Europe and US occasionally