Investigator, Process Technology & Manufacturing Systems

Role Summary

The Investigator leads the industrialization and introduction of Single-Use (SU) process technologies for biological manufacturing, manages vendor relationships, supports GMP use of SU technologies, and provides training and guidance on SU systems. The role involves troubleshooting, technical documentation, and collaboration with various teams to ensure a robust manufacturing platform.

Responsibilities

• Leads the industrialization and introduction of new Single-Use (SU) process technologies for upstream and downstream biologicals manufacturing; collaborates with CMC matrix teams and GSK Biopharm manufacturing sites to deliver a robust SU technology manufacturing platform.
• Leads process troubleshooting and investigation activities for SU manufacturing processes. Manages vendor relationships with SU Technology providers, including audit and change management support, new technology development, and collaborations with key strategic partners. Supports and guides GMP use of SU technologies and works with Supply Chain and Procurement to ensure continuity of supplies.
• Responsible for authoring and approval of technical SU batch documentation.
• Provides training and guidance to Manufacturing Scientists on SU systems and technologies.
• Member of the GSK Biopharm SU Task Force.
• Monitors use of SU technologies for upstream and downstream production.
• Leads the industrialization of SU technology essential to large scale cGMP production. Solves SU process and equipment problems. Recommends equipment and procedures. Keeps aware of new technology developments. Technical expert in cell culture, fermentation, and/or purification technologies, with knowledge in all areas desirable.
• Prepares and approves SOPs for the use of SU technologies.

Qualifications

• Required: B.S. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with 7+ years relevant experience, or M.S. with at least 5+ years' experience, or PhD with at least 3+ years' experience, in one of the following areas:
  • Lab/pilot scale cell culture operations including small scale seed scale up, SU bioreactor operations, alternating tangential flow filtration (ATF), depth filtration, centrifugation and media preparation.
  • Lab/pilot scale protein purification methods, including chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation.
  • Experience in the design and use of Single Use Technologies.
  • Experience in a GMP environment.
  • Experience in troubleshooting and root cause analysis methodologies.

• Preferred: Expert in the design and use of Single Use Technologies.
• Preferred: Expert in cGMP practice and regulatory requirements.
• Preferred: Expert in technology transfer and process scale-up.
• Preferred: Expert in troubleshooting/problem analysis skills, including experience with Lean Sigma and Root Cause Analysis methodologies.
• Preferred: Excellent written and oral communication skills.

Education

• See Qualifications above for degree requirements (B.S./M.S./PhD in related fields).