Scientist, Downstream Process Development

Zoetis•Kalamazoo, MI

19d•Onsite

About The Position

The Scientist will work in the Downstream Process Development group within Biologics Process Development at Zoetis Development Sciences and Technologies. The role supports development of isolation, purification, and concentration steps for vaccines and therapeutic proteins, including monoclonal antibodies, and process characterization studies that support transfer to manufacturing. The Scientist will maintain GLP documentation for global regulatory submissions and contribute to identifying and developing new technologies. The role also supports discovery, analytical, and diagnostic laboratories with small-scale preparations; develops chromatography and filtration processes; and optimizes therapeutic protein production processes. The Scientist will assist with transferring new products to Zoetis Biological Manufacturing sites. The position serves as a technical resource and liaison across Zoetis teams and external partners. It represents the department on cross-functional development teams and provides written and oral reports to project teams and management. Work is conducted under GLP/cGMP requirements to produce regulatory-compliant documentation supporting process transfers. The position is based in Kalamazoo, Michigan, with interactions involving colleagues and external partners around the globe.

Requirements

B.S. in Biochemistry, Biotechnology, Chemical/Biochemical Engineering, or a related field.
For Scientist level: B.S. with 7+ years of experience or M.S. with 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 purification of 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 all types of 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-oriented approach, positive attitude, good organizational skills, and high motivation.

Responsibilities

Develop process steps for the isolation, purification, and concentration of vaccines and therapeutic proteins, including monoclonal antibodies.
Run 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 in processing small-scale preparations.
Develop chromatography and filtration processes, including evaluation of chromatographic modalities and dead-end and crossflow filtration.
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 a network 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 DSP group and partner groups, including 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.
Provide finished oral and written communication reports to project teams and management.
Work under GLP/cGMP to provide high-quality, regulatory-compliant technical documentation in support of process transfers to manufacturing.