Scientist, Downstream Process Development

Zoetis; Kalamazoo (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Zoetis in Kalamazoo, MI, seeks a scientist to join the Downstream Process Development group within Biologics Process Development. The role includes developing steps for isolation, purification, and concentration of vaccines and therapeutic proteins, including monoclonal antibodies, and supporting transfer to manufacturing.

The candidate will maintain GLP documentation for global regulatory submissions and collaborate with discovery, analytical, and diagnostic labs.

Qualifications

• BS with 7+ years of experience or MS with 6+ years of experience.
• Experience in multiple types of low pressure chromatography development.
• Experience with crossflow and dead-end filtration development.
• Familiarity/experience in purification of monoclonal antibodies.
• Familiarity/experience with basic analytical methods (HPLC, gel electrophoresis, total protein analysis).
• Strong communication and interpersonal skills.

Responsibilities

• Develop process steps for isolation, purification, and concentration of vaccines and therapeutic proteins (including monoclonal antibodies).
• Run process characterization studies to support transfer into manufacturing.
• Maintain GLP/cGMP documentation for regulatory submissions.
• Serve as liaison between Biologics Process Development DSP and other groups (Discovery, Pilot, GMS, Regulatory).
• Prepare finished oral and written reports to project teams and management.

Skills

Chromatography development

Filtration development

Monoclonal antibody purification

Analytical methods (HPLC, gels)

Communication skills

Interpersonal skills

Multi-tasking

Team collaboration

Education

BS in Biochemistry / Biotechnology / Chemical Engineering

MS in a related field (preferred)

Tools

AKTA systems

HPLC systems

Job description

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.

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

• 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 time Regular Colleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [e-mail] to request an accommodation.

Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.

In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

At Zoetis, our purpose is to nurture our world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.