The Global Manufacturing Science and Technology (MSAT) organization is a network focused function which provides strategic direction, technical and operations support to ensure that GSK Global Supply Chain network goals and objectives are achieved, through a focused strategy execution.

As an accountable Senior Subject Matter Expert (SME), this role will 1) collaborate closely with internal and external stakeholders, to support the ongoing commercial manufacture of large molecule Drug substances and/or sterile Drug Product, ensuring technical lifecycle support and 2) execute MSAT/EM technical strategy and activities for manufacturing processes including routine operation, field, technical support, and validation.

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

• Execute technical strategy and represent MSAT Technical Operations for External Manufacturing in relevant PQTS teams
• Ensure support for CMOs in establishing maintenance, performance of standards, and technical transfers of established products or transfers between CMOs
• Support CMO for audit documentation, inspection readiness, and prepare local teams during audits.

• Ensure critical lifecycle activities:

  • CPV
  • Change control
  • Deviation investigation and resolution
  • CAPAs
  • Waste mapping
  • Performance of standards.
  • Continuous Improvement (financial, process, etc)

Why You?

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

• Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
• 7+ years’ experience in drug substance and/or drug product (including device) technical operations in pharmaceutical or biologics manufacturing.
• Experience of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
• Experience in identifying and leading continuous improvement
• Lead technical investigations, perform root cause analysis, manage change control, and develop corrective and preventive actions (CAPA).
• Experience collaborating with external manufacturing partners.

Preferred Qualification

If you have the following characteristics, it would be a plus

• Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.

• Certification or formal training in project management, risk management, or continuous improvement methods (for example Lean or Six Sigma).

• Experience supporting regulatory inspections and preparing technical responses.
• Proven track record of successful technology transfers to CMOs or external partners.
• Experience coaching and developing technical capability across multi-site or global teams.

#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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive eq