Formulation & Lyophilization Lead Scientist

Zoetis is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.

Benefits Include:

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing.

Tuition reimbursement and Student Loan repayment program.

Great Health, personal, and family benefits starting day 1.

Position Summary

This is an individual contributor, site-based role where the focus of the individual’s attention will be on

• Supporting the site Global Manufacturing Technology (GMT) team in New Product Introductions (NPI) from Research and Development (VMRD) into the site,
• Technology transfers of current processes from one site to another within the network,
• Support manufacturing teams in maintaining and improving the performance of vaccine production.

This position requires at least 5 years of experience in a biological or biopharma manufacturing or research environment, hence the expectation is that the individual will apply their technical skills and knowledge independently and work on multiple NPIs, manufacturing transfer projects and/or continuous improvement projects in parallel.

Hours: 1st Shift, 7:15am – 3:45pm. Some weekends due to experimental designs.

Position Responsibilities

You will be member of multiple new product introduction (NPI) teams, where you will be responsible for:

• Working closely with VMRD to co-develop new products suitable for transfer into the production facility.
• Understanding the capacity of your current facility and requirements to process fit a new product.
• Identify product constraints during development and make suggestions for improvements to facilitate the scale up and commercial manufacture of a process.
• Be a member of the site transfer team to transfer the process into manufacturing.
• Take accountability for transferring the process “as is” form VMRD into manufacturing.
• Train production personnel on the new process and ensure knowledge of the process is passed onto production teams.
• Support manufacturing in preparing batch records for new products.

You will be a member of the site-to-site technology transfer teams where you will be responsible for the:

• Assessment of the process or analytical gaps in the sending and receiving site
• If a member of the sending site provides technical support to receiving site
• Potentially travel to receiving site to support transfer of knowledge.

You will work on several continuous improvement project to support the site priorities.

• Develop process control charts for the appropriate vaccine processes.
• Take ownership and champion the performance of a range of formulation and lyophilization manufacturing processes.
• Identify process improvements that result in improved supply reliability, reduction in zero yields, reduction in scrap, improvement in process yields.
• Support Procurement in sourcing alternative raw material, component, and primary packaging suppliers to help reduce cost for the site and maintain supply.

Provide technical support to immediate site investigations that may have an impact on supply of product to the market. Investigate new technologies and implement changes to site where beneficial.

Education and Experience

BS or MS in a life science (virology, bacteriology, or immunology), related to engineering, or equivalent biological experience is required with emphasis on formulation, adjuvant, and/or lyophilization sciences experience. Demonstrated competency in formulation process and analytical method development. This position requires a minimum of 5 years in manufacturing process experience and product transfer experience.

Previous experience in developing and scaling up formulation and lyophilization processes and process analytical experience is highly desirable.

Technical Skills and Competencies Required

• Laboratory and /or manufacturing experience in biological manufacturing and/or testing is highly desirable with specific experience in formulation, adjuvant, and/or lyophilization processes and analysis.
• A working knowledge of vaccine production methods and experimental design and experience in GLP or GMP is also desirable.
• Basic knowledge of USDA, FDA, and EU regulatory systems desired.
• Strong technical analytical skills and possess a high degree of personal motivation.
• Strong oral and written communication, excell