Investigator, Process Technology & Manufacturing Systems

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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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 SOP's for the use of SU technologies.

Why you?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• B.S. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with7+ 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 Qualification
If you have the following characteristics, it would be a plus:

• Expert in the design and use of Single Use Technologies.

• Expert in cGMP practice and regulatory requirements.

• Expert in technology transfer and process scale-up.

• Expert in troubleshooting/problem analysis skills, including experience with Lean Sigma and Root Cause Analysis methodologies.

• Excellent written and oral communication skills

How to apply
If this role matches your skills and ambition, we encourage you to apply. Tell us about your investigation experience and the impact you made. We want to hear how you solve problems, collaborate with others, and help keep manufacturing safe and compliant. Join us and help make a difference.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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