Team Leader – mAbs Process Team

Zoetis•Lincoln, NE

2d•Onsite

About The Position

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 Lead a team of biomanufacturing operators for the production of monoclonal antibodies (mAb) ensuring the GMP standards are followed. Develop, train, and grow a talented team of operators by teaching the “why” of the process. Assist with scheduling batches, batch records review, troubleshooting technical challenges, and batch release. Hours: 1st shift, Monday – Friday, 7:30 a.m. – 4:00 p.m. / Plus On-call rotation Position Responsibilities Looking for a people-focused leader to lead the monoclonal antibody manufacturing processing area. Recruit, lead, coach, and retain a high performing operations team (~8 direct reports). As a leader, you will set the tone for the area to maintain an effective and engaged manufacturing group following GMP requirements. Train and supervise on-the-floor operations of commercial monoclonal antibody manufacturing under GMP. Effectively manage the day-to-day operations by assisting with production and resource schedule against operational plan. Design reporting standards for operational metrics and process KPIs to drive operation efficiencies and employee experiences. Investigate process excursions/deviations and production issues utilizing six sigma tools to ensure corrective actions are identified and implemented to eliminate the root cause of the problem. Support initiation and closure of deviations within the defined timeline, and CAPA implementation. Review of completed manufacturing documentation per compliance standards and established timelines. Draft SOPs, batch records, validation protocols and reports for equipment and procedures needed for the process. Work cross-functionally with multiple teams to ensure your area delivers the highest quality products and provide your team with the tools, resources and support needed to achieve their goals. Identify opportunities for process optimization and efficiency. Assist with multi-functional technical projects within area of responsibility. Efficiently communicate relevant information with other shift Team Leaders and manufacturing teams. Support inventory audits and cycle counts to ensure accuracy and compliance. Champion GMP compliance. Maintain regulatory compliance and ensure area audit readiness.

Requirements

Degree in Biological Sciences, Chemical Engineering, Biochemistry, or in any relevant disciplines is required.
Expectation of minimal relevant experience requirement: Bachelor + 5-7 years, Master + 3-5 years, PhD + 1-2 years.
Experience with working in a GMP environment.
Relevant experience in Monoclonal Antibody manufacturing and/or aseptic manufacturing.
Ability to engage with others, collaborate, and lead high performing operation team.
Enthusiastic to teach someone something new every day.
Excellent communication (written and oral) with attention to detail.
Self-starter, able to prioritize work on multiple concurrent projects and work efficiently with minimal guidance.
Strong computer, scientific, and organization skills.
Demonstrated record of working in a team environment.

Nice To Haves

Management experience: 1 year preferred.

Responsibilities

Lead a team of biomanufacturing operators for the production of monoclonal antibodies (mAb) ensuring the GMP standards are followed.
Develop, train, and grow a talented team of operators by teaching the “why” of the process.
Assist with scheduling batches, batch records review, troubleshooting technical challenges, and batch release.
Recruit, lead, coach, and retain a high performing operations team (~8 direct reports).
Train and supervise on-the-floor operations of commercial monoclonal antibody manufacturing under GMP.
Effectively manage the day-to-day operations by assisting with production and resource schedule against operational plan.
Design reporting standards for operational metrics and process KPIs to drive operation efficiencies and employee experiences.
Investigate process excursions/deviations and production issues utilizing six sigma tools to ensure corrective actions are identified and implemented to eliminate the root cause of the problem.
Support initiation and closure of deviations within the defined timeline, and CAPA implementation.
Review of completed manufacturing documentation per compliance standards and established timelines.
Draft SOPs, batch records, validation protocols and reports for equipment and procedures needed for the process.
Work cross-functionally with multiple teams to ensure your area delivers the highest quality products and provide your team with the tools, resources and support needed to achieve their goals.
Identify opportunities for process optimization and efficiency.
Assist with multi-functional technical projects within area of responsibility.
Efficiently communicate relevant information with other shift Team Leaders and manufacturing teams.
Support inventory audits and cycle counts to ensure accuracy and compliance.
Champion GMP compliance.
Maintain regulatory compliance and ensure area audit readiness.