Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives.
We are currently seeking a Manufacturing Manager to join the External Manufacturing & Supply Operations team based in our EU subsidiary site in Zug, Switzerland.
The position will support production efforts at Contract Manufacturing Organizations (CMOs) throughout Europe, with an emphasis on oral solid dosage manufacturing.
Develop expertise in manufacturing processes and provide technical input to internal development teams and CMOs.
Participate in multi-functional project teams during technology transfer and manufacturing stages of projects.
Facilitate internal and external discussions to identify, address, or escalate (as needed) technical or business challenges, disputes, and questions
Develop strong technical and business relationships with CMOs and serve as an advocate for the organization’s interests.
Provide onsite oversight for small molecule manufacturing 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 of such documents to meet project timelines.
Develop, monitor, and maintain positive business relationships with CMOs and partners to encourage collaboration, improvements, transparency, and accountability.
Degree in chemistry or other Life Science with 7+ years relevant experience in biotechnology or pharmaceutical industry.
Extensive oral solid dosage process knowledge including proficiency with solid dose equipment, experience with product scale-
up and technology transfer. Experience with Spray-Dried Dispersion (SDD) technology desirable.
Demonstrated proficiency in small molecule manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practices.
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.
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.