Role Description
The candidate will work in the Protein Preparation Laboratory and Downstream Process Development group within Biologics Process Development of Zoetis Development Sciences and Technologies.
The successful applicant will work with other team members to produce multiple preparations of monoclonal antibodies and therapeutic proteins in a fast-paced R&D space engaged in numerous projects. The incumbent is expected to work hands-on at the bench while learning strong technical skills in both upstream production and downstream purification workflows.
They are expected to work in partnership with colleagues in upstream/downstream development, formulation development, and bioanalytical science. In addition, the candidate will be expected to maintain Good Documentation Practices in support of global regulatory submissions for product licensure. Moreover, they will be involved in identification and development of new technologies and will provide support to Downstream and Upstream development. They will also assist with new product transfers to Biological Manufacturing sites within Zoetis.
Additional duties and responsibilities include:
- Aseptically culture cells and production systems such as CHO cells for the expression of monoclonal antibodies (mAb) and recombinant proteins.
- Operate bench- and mid-scale bioreactor systems that are used within the laboratory to routinely produce mAbs and therapeutic proteins.
- Operate multiple modalities of chromatography and filtration systems that are routinely used to isolate, purify, and concentrate mAbs and proteins.
- Coordinate with cell culture and downstream development groups on the procedures, raw materials and equipment required for a successful mid-scale batch.
- Learn to serve as a company resource in protein isolation, purification, and scaling of bioreactor systems and downstream processes as it relates to manufacturing processes.
- Serve as a technical liaison between Biologics Process Development - Downstream Development group, Upstream Development team, and other partner groups such as Discovery, Pilot, GMS and Regulatory.
- Establish a network within Zoetis and with key suppliers and institutions to serve business needs, and provide cost effective, innovative solutions for Zoetis.
- Regularly communicate via excellent written and verbal interactions, as well as clear technical presentations to project teams and management.
- Work within GLP/cGMP documentation standards to provide high quality, regulatory compliant technical documentation in support of technology transfer within the company or to contract manufacturers and well as to support regulatory filings for new product registrations.
- Strive for continuous improvement in the existing workflow, technologies, and techniques utilized in bioprocess development.
- Maintain electronic laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures.
- Demonstrate excellent organizational skills in order to engage in multiple projects.
- Bolster the highly collaborative team environment necessary across the biopharmaceutical development programs.
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
- Preferred: BS with 3-8 years of experience or MS with 0-6 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 and hybridoma antibodies.
- Familiarity/Experience with basic analytical methods which may include HPLC, gel electrophoresis, and total protein analysis.
- Familiarity/Experience in aseptic technique and cell culture.
- Familiarity/Experience in bioreactor/fermenter operation.
- 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.
- Experience with principles of scale-up and scale-down to bioreactor systems and downstream processes.
- 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.
About Zoetis
At Zoetis we are passionate about our customers and the animals in their care. We discover, develop and manufacture the world's most innovative and effective products for animal health-medicines, vaccines, diagnostics, genetic tests, biodevices-and we are creating the next generation of integrated solutions and services to support this evolving industry. We know our people drive our success. Our colleagues are proud of our company culture and the meaningful role we play in caring for animals. The Zoetis Core Beliefs define the commitments we make to our colleagues, customers and stakeholders every day. They have guided the creation of our award-winning workplace and our proud position as a leading partner of choice in animal health.
Diversity, Equity & Inclusion
Our Colleagues Make the Difference, and we know their differences make Zoetis stronger. We strive to create an environment where each colleague feels valued and cared for and where we can be our best every day. Our Diversity, Equity & Inclusion (DE&I) focus and commitment begins with our leadership team of diverse backgrounds, experiences and ethnicities (50% of our executive team members are women), and it is demonstrated in our support of our colleagues and industry. Our Diversity, Equity & Inclusion Council, representing colleagues across locations, functions and communities, serve as ambassadors and champions for DE&I initiatives. In addition to the Diversity, Equity & Inclusion Council, Zoetis has six colleague resource groups that bring together colleagues who share similar backgrounds, experiences, or interests and work together toward goals aligned with our strategic business priorities.
Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a Best Place to Work for LGBTQ Equality, a 100 Best Company for Working Mothers, a Top Company for Executive Women, among many others.
For animals. For health. For you.
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