The MSAT Director is accountable to:

• Organize and lead the MSAT (Manufacturing Science and Technology) organization at Marietta, PA.

• Ensure that the MSAT organization drives and support the following pillars:

  • Product & Process Mastery.

  • Technology leadership to develop a competitive edge.

  • Continuous improvement of processes and technology.

  • Troubleshooting of products and processes.

  • Creating a learning organization through knowledge management of products, processes, and technology.

• Own and lead product and process governance so that initiatives are prioritized to deliver the most impact.

• Drive the technology roadmap to position Marietta as a leading site and a preferred site for product launch and manufacturing investment. Develop the organization through active establishment and maintenance of relationships with global MSAT (process science, TLCM, technology, digital), AR&D, and TR&D.

Key Responsibilities:

• Product and process mastery:  Drive technology transfers into and out of the manufacturing site to meet business objectives.

• Product and process mastery:  Drive product stewardship through monitoring of manufacturing process through Continuous Process Verification.  Identify trends in the manufacturing process, investigate and propose technical solutions.  Lead the identification and prioritization of projects and initiatives to improve process robustness and data-based process understanding, yield, and evaluation and implementation of new manufacturing technology.

• Troubleshooting of products and processes:  Lead troubleshooting investigations and provide expert support.  Defend output of investigations during audits and inspections. 

• Technology leadership:  Define strategies and approaches to ensure state-of-the art and robust manufacturing technologies are evaluated and implemented.

• Continuous Improvement:  Ensure the validated state of the GMP-related systems and manufacturing processes, through ownership of site validation plans, SOPs, and expertise to deliver annual plans. Execution and documentation of validation activities in line with regulatory and GSK standards.

• Technical Leadership:  Provide expert leadership and influence with other site MSAT teams, global MSAT, Manufacturing Strategy, Global Quality, TR&D and AR&D for life-cycle innovations, validation strategies and Co-Development topics.

• Creating a learning organization: Drive Learning with focus on manufacturing technologies, scientific background for manufacturing processes and usage of digital process data.

• Ensure product and process compliance with regulations, company standards, QMS, EHS policies, analytical standards, and GPS standards.

Why You?

Basic Qualifications:

• Bachelor’s degree in chemical engineering, biology, biochemistry, chemistry, or equivalent science or engineering degree.

• 10+ years of work in GMP-regulated vaccines/biotech environment, in R&D, TRD, or production-site related roles

• Knowledge of vaccines/biotech operations and how to work in a GMP environment

Preferred Qualifications:

• Master’s or PhD

• Excellent knowledge of regulatory and legal requirements cGMP rules and standards

• Very good knowledge of biotechnological manufacturing and control processes.

• Deep technical and scientific background and competency to credibly lead the science/technology driven team.

• Strong continuous improvement mindset and efficiency-driven focus setting.

• Excellent communication and influencing skills, successful stakeholder management.

• Experience in global network operations.

• Skills to lead a team in an ever-changing environment.

• Strong organizational skills.

• Very good internal and external communication.

• Problem solver.

• Analytical and integrative thinking.

• Knowledge of the GSK organization would be a plus, though not mandatory.

• High capability to innovate.

• Highly effective at internal and external influencing.

#LI-GSK

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: