Sr. Specialist, Operations

Job Description

We are seeking a highly motivated Senior Specialist to join our Process Excellence Team within the Global Animal Health Manufacturing (GAHM) Science and Technology Excellence Organization. The Process Excellence team works across the GAHM network to improve process and analytical robustness of our products, drive operational efficiencies, and manage risks proactively. 

The Process Excellence Senior Specialist will report to the Process Excellence Lead and will be based at one of our Animal Health Manufacturing locations in the US, providing support to all US sites and other regions as needed. We are looking for someone with strong technical knowledge in the field of biomanufacturing and strong problem-solving skills. The individual will be responsible for leading key process robustness initiatives and critical investigations to enable top line sales growth, improve bottom line P&L, and improve productivity.  

Key Responsibilities include: 

• Work with US site and regional S&T teams (other regions as needed) to identify the top process robustness opportunities across the portfolio 

• Collaborate with cross-functional teams to identify opportunities for process robustness and optimization and develop strategies to implement sustainable improvements. 

• Lead/support critical investigations related to process issues. Utilize problem solving methodologies such as 8-Step Problem Solving to analyze processes, identify root causes of inefficiencies, and develop robust solutions 

• Travel to sites to provide hands on support when needed 

• Leverage digital and data to make problems/risks/opportunities visible and help teams to solve them 

• Collaborate with senior leadership to develop and implement strategic initiatives for process excellence and business process optimization. 

• Act as a subject matter expert in process improvement methodologies and contribute to the development and maintenance of best practices within the organization. 

Qualifications: 

• Bachelor’s degree in Engineering, Biochemistry or related field 

• 5+ years of experience in biopharmaceutical manufacturing science and technology or operations  

• 5+ years of project management experience in cross functional organizations 

• Previous experience with leading 8-step problem solving investigations 

• Demonstrated technical knowledge and understanding of USP/DSP/B&F processes 

• Previous experience in managing data-driven projects 

• Excellent presentation and communication skills at all levels within the organization 

• Proven development and change management skills, with the ability to influence and motivate others. 

• Comfortable playing a variety of roles including hands-on work, solving problems, and working across organizational boundaries. 

• Evidence of being able to think both strategically and operationally. 

• Knowledge and/or working experience with regulatory requirements (e.g. FDA, EMA) and quality systems (e.g. GMP) in the pharmaceutical industry. 

The successful