Scientist, Downstream Process Development

Role Description

The candidate will work in the Downstream Process Development group within Biologics Process Development of Zoetis Development Sciences and Technologies. The successful applicant will assist in developing process steps for the isolation, purification, and concentration of vaccines and therapeutic proteins, including monoclonal antibodies, as well as running process characterization studies to support transfer into a manufacturing setting. The candidate will be required to maintain appropriate GLP documentation in support of global regulatory submissions for product licensure. He or She will be involved in identification and development of new technologies and will provide support to discovery, analytical, and diagnostic laboratories in the processing of small-scale preparations. He or She will be responsible for chromatography and filtration development, including evaluating different chromatographic modalities and evaluating dead-end and crossflow filtration processes, and for the optimization of therapeutic protein production processes. He or She will assist with new product transfers to Biological Manufacturing sites within Zoetis.

Additional duties and responsibilities include:

• 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 for Zoetis.
• Serve as a technical liaison between Biologics Process Development - DSP group and other partner groups such as Discovery, Pilot, GMS and Regulatory.
• Serve as department project team representative 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.
• The position is based in Kalamazoo (Michigan, USA) with interactions with colleagues and external partners located around the globe.

Qualifications:

Educational Background:

• Minimum: B.S. Biochemistry, Biotechnology, Chemical/Biochemical Engineering, or a related field
• Requirement for Scientist: BS with 7+ years of experience or MS with 6+ years of experience.

Work Experience/Skills:

Minimum:

• Familiarity/Experience in multiple types of low pressure chromatography development.
• Familiarity/Experience in crossflow and dead-end filtration development.
• Familiarity/Experience in the purification of monoclonal antibodies.
• Familiarity/Experience with basic analytical methods which may include HPLC, gel electrophoresis, and total protein analysis.
• Strong communication skills, both oral and written. Strong interpersonal skills, ability to work effectively with all types of personalities.

Desirable:

• Experience with mid-scale and/or large scale protein/vaccine preparations.
• Experience with Design of Experiments (DOE) planning, execution, and analyzing data.
• 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.

Other Attributes Desirable:

• Highly computer literate. Capable of quickly learning and adapting to new computer programs.
• Experience with technical transfers.
• Ability to multi-task; working on multiple projects simultaneously.
• Team player, positive attitude, good organizational skills, and highly motivated.

Full timeRegularColleague

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