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 and characterization of processes for isolating, purifying, and concentrating vaccines and therapeutic proteins, including monoclonal antibodies, and supports transferring processes into manufacturing. The position involves maintaining GLP documentation for global regulatory submissions, identifying and developing new technologies, and supporting discovery, analytical, and diagnostic laboratories with small-scale preparations. The Scientist will develop chromatography and filtration processes, evaluate chromatographic modalities and dead-end and crossflow filtration, and optimize therapeutic protein production processes. The role also supports transfers of new products to Zoetis Biological Manufacturing sites. The Scientist will build expertise in protein isolation and purification for manufacturing, develop relationships within Zoetis and with suppliers and institutions, and provide technical liaison and project-team support across functions. The position requires clear written and oral reporting to teams and management and high-quality, regulatory-compliant technical documentation under GLP/cGMP. The position is based in Kalamazoo, Michigan, with interactions with colleagues and external partners around the globe.
Requirements
- B.S. in Biochemistry, Biotechnology, Chemical or Biochemical Engineering, or a related field.
- For the Scientist level: a bachelor's degree with 7 or more years of experience, or a master's degree with 6 or more years of experience.
- Familiarity or experience with multiple types of low-pressure chromatography development.
- Familiarity or experience with crossflow and dead-end filtration development.
- Familiarity or experience purifying monoclonal antibodies.
- 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 with 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 across multiple projects simultaneously.
- Team-oriented approach, positive attitude, good organizational skills, and high motivation.
Responsibilities
- Develop process steps for isolating, purifying, and concentrating vaccines and therapeutic proteins, including monoclonal antibodies.
- Conduct process characterization studies to support transfer into a manufacturing setting.
- Maintain appropriate GLP documentation for global regulatory submissions supporting product licensure.
- Identify and develop new technologies.
- Support discovery, analytical, and diagnostic laboratories with 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.
- Develop expertise as a company resource in protein isolation and purification as it relates to manufacturing processes.
- Establish networks within Zoetis and with key suppliers and institutions to support business needs and provide cost-effective, innovative solutions.
- Serve as a technical liaison between the Biologics Process Development downstream process development group and partner groups such as Discovery, Pilot, GMS, and Regulatory.
- Represent the department on cross-functional development project teams, including teams for cell line development, cell culture, bacteriology, formulation development, and bioanalytical sciences.
- Prepare and deliver written and oral reports to project teams and management.
- Work under GLP/cGMP and provide high-quality, regulatory-compliant technical documentation supporting process transfers to manufacturing.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
