Scientist, Downstream Process Development
About The Position
The Scientist will work in the Downstream Process Development group within Biologics Process Development, part of Zoetis Development Sciences and Technologies. The role supports development of process steps for isolating, purifying, and concentrating vaccines and therapeutic proteins, including monoclonal antibodies, and conducts process characterization studies to support transfer into manufacturing. The Scientist maintains appropriate GLP documentation for global regulatory submissions supporting product licensure. The position develops and evaluates chromatography and filtration processes, including different chromatographic modalities and dead-end and crossflow filtration, and optimizes therapeutic protein production processes. It also supports discovery, analytical, and diagnostic laboratories with small-scale preparations; identifies and develops new technologies; and assists with new product transfers to Zoetis Biological Manufacturing sites. The role serves as a technical resource and liaison across Zoetis partner groups and external suppliers and institutions, and represents the department on cross-functional development teams. It prepares written and oral reports for project teams and management and works under GLP/cGMP requirements to produce high-quality, regulatory-compliant documentation. The position is based in Kalamazoo, Michigan, USA, and involves interactions with colleagues and external partners around the globe.
Requirements
- Bachelor’s degree in Biochemistry, Biotechnology, Chemical/Biochemical Engineering, or a related field, with at least 7 years of experience; or a master’s degree with at least 6 years of experience.
- Familiarity or experience in multiple types of low-pressure chromatography development.
- Familiarity or experience in crossflow and dead-end filtration development.
- Familiarity or experience in monoclonal antibody purification.
- Familiarity or experience with basic analytical methods, which may include HPLC, gel electrophoresis, and total protein analysis.
- Strong oral and written communication skills.
- Strong interpersonal skills and ability to work effectively with people of varied personalities.
Nice To Haves
- Experience with mid-scale and/or large-scale protein or vaccine preparations.
- Experience planning, executing, and analyzing Design of Experiments (DOE).
- Experience with automated chromatography systems such as AKTA.
- Knowledge of regulatory issues associated with USDA and EU biologics submissions.
- Knowledge of GXPs, including process validation.
- High computer literacy and ability to quickly learn and adapt to new computer programs.
- Experience with technical transfers.
- Ability to multitask and work on multiple projects simultaneously.
- Team-player attitude, positivity, good organizational skills, and high motivation.
Responsibilities
- Develop process steps for the isolation, purification, and concentration of vaccines and therapeutic proteins, including monoclonal antibodies.
- Conduct process characterization studies to support transfer into a manufacturing setting.
- Maintain appropriate GLP documentation in support of global regulatory submissions for product licensure.
- Identify and develop new technologies.
- Support discovery, analytical, and diagnostic laboratories with processing small-scale preparations.
- Develop chromatography and filtration processes, including evaluating chromatographic modalities and dead-end and crossflow filtration processes.
- Optimize therapeutic protein production processes.
- Assist with new product transfers to Zoetis Biological Manufacturing sites.
- Learn to serve as a company resource in protein isolation and purification as it relates to manufacturing processes.
- Establish a network within Zoetis and with key suppliers and institutions to serve business needs and provide cost-effective, innovative solutions.
- Serve as a technical liaison between the Biologics Process Development DSP group and partner groups such as Discovery, Pilot, GMS, and Regulatory.
- Represent the department on cross-functional development project teams, including cell line development, cell culture, bacteriology, formulation development, and bioanalytical sciences.
- Prepare and provide oral and written reports to project teams and management.
- Work under GLP/cGMP requirements to provide high-quality, regulatory-compliant technical documentation supporting process transfers to manufacturing.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
