MS&T SME

Tunnell Consulting•Columbus, OH

3d•Onsite

About The Position

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston. Tunnell Consulting, looks for top consultants on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client’s needs a Manufacturing Science & Technology (MS&T) SME. This is a contract position for 3-6 months. Work to be performed Onsite. Our client is located in the Greater Columbus area. Subject Matter Expert (SME) – Manufacturing Science & Technology (MS&T) Job Summary The MS&T Subject Matter Expert (SME) provides technical expertise and support for manufacturing processes throughout the product lifecycle. This role works closely with Manufacturing, Quality, Engineering, and Supply Chain teams to ensure robust processes, successful technology transfers, process improvements, and consistent product quality.

Requirements

Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
Experience in Manufacturing Science & Technology (MS&T), Process Engineering, Manufacturing, or Pharmaceutical/Biotech operations.
Strong understanding of manufacturing processes, process validation, and technology transfer.
Experience with root cause analysis, process troubleshooting, and continuous improvement.
Strong analytical, problem-solving, and communication skills.

Responsibilities

Serve as the technical expert for manufacturing processes and technologies.
Support process development, scale-up, validation, and commercial manufacturing activities.
Lead and support technology transfer projects between development, manufacturing sites, and external partners.
Investigate manufacturing deviations, process issues, and product quality concerns.
Analyze process data and identify opportunities for continuous improvement.
Develop and maintain process documentation, technical reports, and standard operating procedures (SOPs).
Partner with cross-functional teams to optimize manufacturing performance and product quality.
Support change controls, risk assessments, and regulatory inspections.
Ensure compliance with GMP, quality, and regulatory requirements.
Provide technical training and guidance to manufacturing and support teams.