Develop expertise in Seattle Genetics’ drug substance and drug product manufacturing processes and provide technical input as required
Facilitate internal and external discussions to identify, address, or escalate (as needed) technical or business challenges, disputes, and questions
Provide onsite support during production at CMOs to ensure overall compliance, appropriate resolution to critical issues, and timely progress updates
Support process changes and continuous improvement efforts by application of facility fit, equipment know-how, and novel manufacturing technologies
Perform technical review of master and executed batch records, specifications, deviations, and change requests and manage timely implementation to meet project timelines
Develop, monitor, and maintain positive business relationships with CMOs and partners to encourage collaboration, transparency, and accountability
Degree in biology, chemical engineering, or other Life Science with 3 to 5 years of relevant experience in biotechnology or the pharmaceutical industry
Demonstrated knowledge of biologics manufacturing to cGMP standards including knowledge of regulatory guidelines and product lifecycle management
Knowledge of conjugation or parenteral drug product formulations desirable
Experience working with CMOs on projects including support of commercial and / or clinical manufacturing in a GMP environment
Experience working in global cross-functional teams in a matrix management environment or multi-site organization is desirable
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 (up to 25%) as well as occasional travel to the Corporate HQ in the US
Seattle Genetics 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. .
Seattle Genetics 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.