MSAT Scientist Purification
The successful candidate is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of all Seattle Genetics products, whether manufactured internally or at contract manufacturing organizations (CMO’s). You will provide technical and scientific leadership as subject matter expert (SME) relating to downstream manufacturing processes for internally or externally manufactured projects. You will be responsible for designing and executing purification scale down studies to support process performance troubleshooting and continuous improvement. In addition, there will be opportunities to explore new downstream manufacturing technologies/materials to further improve efficiency and robustness. You will also interface with other high-performing teams within Technical Operations.
- Responsible for purification manufacturing support for clinical and commercial biologics including routine monitoring/trending. Providing guidance for root cause investigations of process related deviations in a timely, comprehensive and conclusive manner
- Design and execute experiments in support of process transfer, troubleshooting, continuous improvement
- Identify and drive technical innovations that will contribute to future business developments and improvements
- Leads the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements
- Acting as person-in-plant during tech transfer, validation studies and manufacturing
- Occasionally acts as Tech Transfer lead for transfer of processes into manufacturing facilities
- Interfacing with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes. Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance
- Partnering with other functions to apply modeling tools ensuring that scale-down/up and characterization of manufacturing processes is robust and scientifically sound leading to a predictable and highly consistent performance and a well characterized process
- Providing guidance for comprehensive facility fit assessments and gap analysis for GMP manufacturing
- Support authorship of CMC regulatory submissions and responses. May function as a process SME during inspections and interactions with regulatory agencies.
- Interact with cross-functional groups (e.g. Process Sciences, Manufacturing, Quality, and Regulatory)
- Outstanding record of accomplishment in areas of purification bioprocess development, improvement and validation
- Knowledge of purification techniques (depth filtration, column chromatography, virus retentive filtration, tangential flow filtration, etc.)
- Hands-on experience with operation and maintenance of bench through pilot scale chromatography systems and TFF equipment
- Knowledge of protein chemistry and analytical techniques (HPLC, SDS-PAGE, Western blotting, etc.)
- Strong scientific and technical experience within purification development and/or manufacturing technologies and unit operations. Preferably experience with equipment utilized in commercial cGMP manufacturing facilities
- Good knowledge of structured methodologies for process design, scale-up/down models, process modeling, process control strategies, process validation and continuous process verification
- The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
- The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally
- Demonstrated skills of independent thought and creativity in science and engineering
- Strong communication skills and computer literacy are essential
- A good understanding of statistical analysis and continuous process verification is desirable
- Demonstrated late-stage regulatory submission experience
- Experience with innovation and operational excellence is desirable
- Bachelor’s degree in chemical engineering, biology or another relevant life-science discipline with a minimum of 8 years of relevant industrial experience
- Alternatively, a Masters’ degree with a minimum of 6 years relevant industrial experience or a PhD degree with minimum 4 years relevant industrial experience
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.