Associate Director/Director, Purification
We are seeking a leader to bring in cutting edge technology, working closely with manufacturing to help develop the future vision of Process Development within Seattle Genetics. You will lead the Purification department within the BioProcess Development organization, providing both technical, managerial and strategic guidance and leadership to the group. The position reports to the Sr. Director of BioProcess Development and interacts closely with Cell Line Development, Cell Culture, Pharmaceutical Sciences, Process Analytical, Regulatory and Quality within the Technical Operations organization.
Essential functions include:
- Directing the group successfully through early and late stage process development and validation activities
- Additional core functions include designing and implementing phase appropriate purification processes to support clinical development while balancing speed, quality, and economics
- Develop a vision for the group, bring in new technologies, establish and pursue goals for technology development consistent with corporate strategy and manufacturing needs
- Author/review key technical and validation reports, as well as relevant CMC sections to support US and EU regulatory filings
- Be responsible for tech transfer of purification processes to SGEN internal manufacturing or contract manufacturing organizations and ensure technical success during manufacturing campaigns
- PhD. degree in Biological Sciences or Chemical Engineering with 8-12 years or M.S with 12-16 years of relevant industrial experience
- Extensive experience with development of robust protein purification processes and scale up to cGMP environment
- Had leadership role in taking late stage processes through process characterization and validation phases
- SME in technical operation of chromatography and UF/DF systems (Akta, FPLC, etc.)
- Solid knowledge of protein chemistry and analytical techniques. Possession of process engineering skills in areas such as Statistical Experimental Design & Analysis, process modeling and process simulation is desired
- Demonstrated ability to collaborate and lead cross-functional technical teams
- Must have enthusiasm to work and provide technical leadership in a team-oriented environment
- Strong management skills and have a proven track record of developing employees
- Possess ability to solve problems methodically; able to take initiative and act independently. Must have excellent written and oral communication skills
As the leading employer in our industry in the Pacific Northwest, 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. 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 Seattle Genetics, please visit www.seattlegenetics.com.
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.