Director/Senior Director Process Development
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.
Process Sciences . Bothell, Washington
Seattle Genetics is the world leader in Antibody-drug Conjugation (ADC) processes. Do you want the opportunity to lead and be a part of the group in driving science and innovation in the field of ADC beyond current state? Through strategic thinking and strong leadership, you will be able to directly contribute to establishing the framework that will support all current and future drug product development activities for ADC and other novel modalities. You will work with a strong and driven team and be part of decision making to drive creative thinking while developing novel ADCs and novel CMC processes while partnering with broader process development and manufacturing organization. We're looking for a leader that will own initiatives, have a focus on excellence and has the potential to grow in a more influential and impactful role. Is this you?
This position is responsible for leading the conjugation process development (CPD) department, setting up the vision and goal for the department and managing the staff with their career and development growth. This position will also be responsible for managing the budget and resources for the department. This position will work closely with BioProcess and Analytical Sciences senior leadership in setting up the goals for the broader process development strategies and bringing in new and relevant technologies. The candidate will define and coordinate resources within process development beyond conjugation to accomplish such strategic objectives, as well as drive continuous improvement and develop long-term strategies to produce world-class ADCs. The position reports to the Executive Director of BioProcess and Analytical Sciences (BPAS) and interacts closely with Cell Line and Cell Culture Development, Purification department, Process and Analytical Chemistry, Pharmaceutical Sciences, Regulatory and Quality within the Technical Operations organization.
- Lead the Conjugation Process Development department within the BioProcess and Analytical Sciences (BPAS) Department, providing technical, managerial and strategic leadership to the group
- Work closely with broader process development and analytical Sciences organizations to develop early and late stage processes, process validation for therapeutic antibodies and drug conjugates.
- Guide the process development activities in designing and implementing phase appropriate processes to support clinical development while balancing speed, quality, and economics.
- Develop the strategies in the group and broader organization for leveraging prior knowledge, data, and scientific innovation to bring speed and efficiency for programs moving from FIH to BLA.
- Develop a vision for the group, bring in new technologies, establish and pursue goals for technology development consistent with corporate strategy and manufacturing needs.
- Collaborate and partner with senior Technical Operations and Process Sciences (TOPS) management to define strategy and vision on CMC related process improvements and defining suitable timelines.
- Author/review key technical and validation reports, as well as relevant CMC sections to support US and EU regulatory filings.
- Guide the department through tech transfer of conjugation processes to SGEN internal manufacturing or contract manufacturing organizations and ensure technical success during manufacturing campaigns.
- Support BioProcess and Analytics Sciences senior staff in defining, evaluating, and establishing new and relevant technology development work streams and lead efforts to identify current and future issues to prioritize technology development areas
- Lead the efforts on the conjugation front for interfacing with research division and Process Chemistry to deepen scientific understanding of how conjugation process can be developed in manufacturing friendly fashion.
- Grow the conjugation department by recruiting, developing and retaining talent to build a scalable organization to handle our robust pipeline.
- Director level: Ph.D. degree in Biological Sciences, Chemistry or Chemical Engineering with a minimum of 15 years or M.S and minimum of 18 years of relevant industrial experience
- Senior Director level: Ph.D. degree in Biological Sciences, Chemistry or Chemical Engineering with a minimum of 18 years or M.S and minimum of 22 years of relevant industrial experience
- Extensive experience with development of robust biological processes and scale up to cGMP environment. Experience with drug conjugates is preferred.
- Extensive experience of leading early and late stage conjugation process development activities including but not limited to Process Characterization and Validation, and deliver with high fidelity, speed and quality
- Experience of scaling up conjugation processes and working with MSAT and manufacturing with essential knowledge of GMP environment
- Experience in authoring relevant CMC sections of regulatory submissions and serve as SME in key regulatory interactions
- Strong management skills and have a proven track record of developing employees
- Create a vision of scientific and operational excellence for CPD and lead the group to achieve it
- Set objectives and metrics for continual improvement on best practices. Run laboratory with high standards of safety, compliance, and efficiency
- Provide mentoring and staff career development. Foster good communication and teamwork among staff. Encourage personal growth. Build a reputation for excellence both as an individual and as a group
- Possession of process engineering skills in areas such as Statistical Experimental Design & Analysis, and process modeling is desired
- Understanding the process impacts on product quality is essential
- Demonstrated ability to collaborate and lead cross-functional technical teams
- Must have enthusiasm to work and provide technical and strategic leadership in a team-oriented environment
- 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.