Head of Process Engineering

Head of Process Engineering in Grafton, WI
 
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. AMRI Grafton manufactures several commercial active pharmaceuticals ingredients (APIs) as well as leads early development and scale up of APIs for several promising drug candidates. 

The Head of Process Engineering at AMRI Grafton site will be an integral part of the site leadership team, contributing to our success by providing technical leadership and engineering support of cGMP manufacturing. The key accountability of this role is successful and optimized cGMP manufacturing and supply of commercial as well as early stage APIs. The Head of Process Engineering will have the opportunity to build and lead a group of process engineers responsible for scale-up, optimization and transfer of processes developed by Process R&D team. In order to develop robust process capability of safe manufacturing processes suitable for large-scale commercial manufacturing, the group is expected to collaborate with process chemists, production staff, EHS Leader, regulatory, QA and analytical development scientists to explore new process technologies and process analytical tools.
 
Key Responsibilities:    

• Lead process scale up and engineering efforts to ensure reliable supply of all products being manufactured at the site. Ensure proactive compliance to all regulatory, safety and environmental regulation and expectations
• Partner with Tech Services to review and approve all regulatory submissions/updates related to API manufacturing 
• Lead efforts to only introduce safe, compliant and cost-effective manufacturing processes in the production area; use statistical tools and/or process scale-up software to develop process understanding and establish protocol for timely campaign reviews as well as for the lessons learned to support next campaign
• Mentor, coach and recruit talent to build capability and leadership bench strength; Develop core competencies of the process development SMEs at the site
  Participate in Site Leadership Team (SLT) meetings and support Site Head/SLT to achieve site goals
• Build capability to perform process safety and hazard reviews of new and existing manufacturing processes
• Collaborate with the Global Procurement and Quality Organizations in supplier selection and Audits
• Collaborate with development scientists to have relevant engineering data available ahead of plant scale-up during early phase development
• Lead projects for implementation of new capital investments (engineering design, start-up and qualification of GMP utilities, process equipment and automation) to support manufacturing goals.
• Support the GMP process and utility equipment, process improvements and the technology transfer of projects from Process R&D and/or AMRI customers.
• Develop and track metrics for process improvements.
• Support root-cause investigations; perform technical assessments of process issues, investigations for process exceptions during the manufacturing campaign.
• Support project teams focused on technology transfer, introduction of new products or processes; process improvements. Provide feasibility assessments and process and equipment requirements

Qualifications and background to be successful in this role:

Required Qualifications

• BS in Chemical Engineering, or related field. 
• Minimum 10 years’ experience in pharmaceutical/biotech operations, with thorough working knowledge of production unit operations and validation principles as applied in manufacturing of active pharmaceutical ingredients.
• Proven track record of leading cross-functional teams
• Excellent communication skills and a strong ability of building and maintaining constructive and effective relationships with internal and external stakeholders as well as strong collaboration and team building skills across cultures, countries, technical competencies, and organizational levels
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA, DEA) required
• Good knowledge of ERP and manufacturing systems used in production
• Understanding of process safety and process hazard issues on scale up
• Proficient in MS Word, Excel, and Project

Desired Qualifications:

• Graduate degree and professional training/certifications. 
• Expert knowledge of chemical development approach, appropriate analytical technology, and applicable regulatory requirements for different drug development phases
• Prior people leader experience  
• Proven track record of impactful Operational Excellence efforts 
• Familiarity with process scale-up software and manufacturing batch control systems, such as, Dynochem, DeltaV, etc
• Design experience in process utility systems including purified water, steam, compressed air, and cooling systems.
• Experience with using statistical tools such as Minitab to drive process improvements in manufacturing.
• Some experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests and site acceptance.