GMT Technical Project Manager - Pharma; Lincoln

GMT Technical Project Manager - Pharma (Lincoln)

Location: Lincoln, NE

Job Level: Based on experience and qualifications

Career Ladder: Technical/Professional

Reports To: Edvins Daiga, GMT Pharmaceutical Drug Product Lead - Pilot Facility & Lincoln

Hours: 1st Shift. May require off-hours support for critical manufacturing issues or project milestones.

• Technical Leadership & Expertise – Subject matter expert for pharmaceutical manufacturing processes including granulation (wet, dry/roller compaction), tableting, coating, and related unit operations. Provide technical guidance on process troubleshooting, root cause analysis, and CAPA implementation. Lead process optimization initiatives to improve product quality, manufacturing efficiency, and cost effectiveness. Support scale-up activities from development through commercial manufacturing. Maintain deep understanding of product formulations, equipment capabilities, and process parameters.
• Project Management & Execution – Lead and manage multiple projects simultaneously of varying complexity, from operational improvements to major technical transfers. Develop project plans, timelines, resource requirements, and risk mitigation strategies. Coordinate cross-functional teams including Manufacturing, Quality, Engineering, Supply Chain, and VMRD. Drive projects to successful completion on time, within budget, and meeting quality objectives. Communicate project status, risks, and outcomes to leadership and stakeholders.
• Technical Transfers & New Product Introduction – Lead technical transfer activities for new products and process improvements to the Lincoln site. Collaborate with VMRD and other sites during co-development and technology transfer projects. Ensure successful process validation and regulatory compliance for transferred products. Develop and execute scale-up strategies from pilot to commercial scale.
• Continuous Improvement & Operational Support – Identify and implement process improvements using structured methodologies (Lean, Six Sigma). Lead investigations and resolve manufacturing challenges impacting production. Support deviation investigations and CAPA implementation. Drive standardization of best practices across equipment and processes.
• Compliance & Documentation – Ensure all activities comply with FDA regulations, cGMP requirements, and Zoetis quality standards. Author and review technical documents including protocols, reports, SOPs, and regulatory submissions. Support regulatory inspections and audits as technical expert. Maintain comprehensive documentation of projects and technical decisions.
• Collaboration & Knowledge Sharing – Interface with leadership, operations, scientists, quality, and cross-functional teams. Mentor junior engineers and scientists in technical and project management capabilities. Share technical expertise and best practices across the manufacturing network. Build strong working relationships with manufacturing, quality, and engineering teams.

• Minimum of Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related technical field.
• Minimum 5 years of experience in pharmaceutical manufacturing or development. Additional experience and project leadership skills preferred.

• Advanced degree (MS, PhD) in relevant technical discipline
• Direct experience with granulation equipment (high shear, fluid bed, roller compaction)
• Experience with various tablet press platforms and coating equipment
• Project Management Professional (PMP) certification or equivalent
• Six Sigma Green Belt or Black Belt certification
• Experience with statistical analysis software (JMP, Minitab)
• Previous experience in pharmaceutical tech transfer or process validation
• Knowledge of Design of Experiments (DOE) and Quality by Design (QbD) principles
• Experience interfacing with VMRD or R&D organizations in co-development activities
• Track record of successful continuous improvement initiatives

Technical Knowledge

• Strong understanding of pharmaceutical manufacturing processes including granulation and tableting
• Knowledge of…