VP GMP Clinical Manufacturing Operations

GSK; Marietta (PA); On-site; USD 250,000 - 350,000; Full time

Job summary

GSK is seeking a VP, Global GMP Clinical Manufacturing Operations to lead the Medicines Global Clinical Manufacturing Operations function. You will ensure timely scale-up, manufacture, and GMP-compliant drug substances and products for clinical trials, and partner with internal and external teams to meet R&D milestones.

The role requires guiding a multi-site operation across six locations, driving modernization, and delivering high-quality clinical supplies, while maintaining compliance with

Qualifications

• Master’s degree in Chemical Engineering, Process Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related field.
• 10+ years experience leading GMP manufacturing operations in a large pharma/biotech setting.
• Experience in cross-modality drug development/manufacturing across all CMC activities.
• Experience with highly regulated GMP processes for medicines/vaccines.

Responsibilities

• Line leadership of global department of ca 300 scientists, engineers, and technicians across 6 sites.
• Ensure on-time scale-up, manufacture and supply to R&D GSK-sponsored clinical trials.
• Drive modernization and digitalisation as part of CMC Digital Strategy & Acceleration goals.
• Oversee major capital projects including Marietta Steriles Facility and UM Flex Factory.
• Monitor external CMO landscape to strengthen internal manufacturing competitiveness.
• Develop and implement strategic workforce plans and succession pipelines.

Skills

GMP Manufacturing

Strategic Leadership

Regulatory Compliance

Budget Oversight

Drug Substance/Drug Product

Education

Master’s in Chemical Engineering

PhD preferred

Job description

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Position Summary

As VP, Global GMP Clinical Manufacturing Operations, you will lead the Medicines Global Clinical Manufacturing Operations function, ensuring the on time scale-up, manufacture, and supply of high-quality, fit-for-purpose, GMP-compliant products for clinical trials in a disciplined and compliant environment. You will play a critical role in ensuring patient safety, clinical data integrity, and delivery of R&D objectives. This is a significant leadership role in delivering R&D portfolio milestones by ensuring all clinical trials are supported seamlessly and on time, and that Drug Substance and Drug Product multi-modality processes are developed and successfully transferred to GSC and/or external manufacturing partners. You will be responsible for driving innovation and modernisation across GMP Manufacturing Operations, building on a strong foundation of operational excellence while ensuring the function remains positioned to support the evolving needs of the R&D portfolio. Reporting to the SVP, Global Clinical Manufacturing and Supply Chain (CMSC) within DDS, you will serve as a member of the CMSC Leadership Team. You will work closely with senior leaders across DDS, GSC, Finance, Quality, Regulatory, and Technical functions to ensure effective delivery of clinical supply requirements across the R&D portfolio. You will also represent DDS and CMSC in senior cross-functional, governance, and external forums as required.

You will provide leadership across six manufacturing locations:

• UK (Ware)
• USA (Upper Merion 38, Upper Merion 29, Marietta)
• Italy (Parma)
• Singapore (Jurong)

Your organization will be responsible for:

• Drug Substance pilot plant operations
• Drug Product pilot plant operations (OSD and Steriles)
• Manufacturing automation
• Oversight of major capital projects, including the Marietta Steriles Facility, UM Biologics Flex Factory, and Jurong Oligonucleotides Facility

Key Responsibilities

• Line leadership of global department of ca 300 scientists, engineering, process technicians and manufacturing experts across 6 sites across 4 countries: including 6 nodes/ Pilot Plants, and a total budget of >£100M.
• Leading the global medicines GMP Operations; accountable for the on time scale up, manufacture and supply to R&D GSK sponsored clinical trials, delivering high quality, GMP compliant drug substance, drug product across all modalities according to R&D objectives and compliance with all internal and external regulations and policies governing clinical supply chain.
• Accountability for the implementation of the functional strategy including modernisation and delivery of the optimised operation ready to support with flexibility the cross-modality R&D Portfolio.
• Driving the comprehensive modernization/digitalisation programme as part of deployment of CMC Digital Strategy & CMC Acceleration goals.
• Oversight and expert input into the design and building of the new GMP pilot plants being built at Marietta and UM Flex factory (major capital projects)
• Monitoring the external CMO landscape and assess advances in manufacturing technologies to identify opportunities to strengthen the competitiveness of internal manufacturing operations.
• Accountability for delivering technical investment proposals with clear recommendations to relevant R&D and / or CMC Governance Board(s); leading and influencing direction at senior forums.
• Regularly reviewing and implementing technologies and ways of working to identify improvements in quality, and efficiency ensuring the clear investment plans for manufacturing technologies across the polit plant network in alignment with partners in GSC; and/or external providers.
• Leader of leaders embracing and drives inclusion to create a modern and dynamic working environment across the global function, where people thrive.
• Developing and implementing a strategic work force plan and a talented and diverse succession pool that is aligned to future needs, reflecting a diverse and highly skilled workforce, and incorporating external capability/collaborations.
• Measuring performance and driving a customer focused, metrics driven, performance management system.
• Leading significant change programmes in the department through exceptional planning, robust engagement and communication plans, and excellence in strategy development and deployment.

Why You?

Basic Qualifications

• Master’s degree in Chemical Engineering, Process Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related scientific discipline.
• 10+ years experience in large pharmaceutical or biotechnology, including experience leading GMP manufacturing operations
• Experience in cross-modality drug development/manufacturing across all CMC activities
• Experience of highly regulated GMP processes necessary to develop a medicine/vaccine ready for commercial release and supply to the clinic
• Line leadership of a global scientific/technical function with significant budget responsibility (>£100s M)
• Oversight/experience of multi-year capital investment projects (over £100M)
• Experience leading organisational change initiatives and/or technology deployment programmes.

Preferred Qualification

s:

• PhD in Engineering or a related scientific discipline.
• Experience leading leaders within a complex matrix organisation, including influencing at senior level meetings, governance boards and executive forums
• Experience across multiple pharmaceutical modalities
• Demonstrated ability to communicate effectively and influence key stakeholder at all levels, both internally and externally
• Expansive and visionary thinker, with demonstrated ability to develop strategic partnerships
• Deep appreciation of the complexity and interdependency of development activities necessary to create a product and a commercially viable manufacturing process, and to deliver supplies for clinical investigation
• Understanding of the key risks and failure modes associated with pharmaceutical development and clinical supply such that they can be effectively identified, discussed, and monitored.
• Deep and rich appreciation of interdependencies with Quality, Regulatory and Technical disciplines, standards, and the performance necessary to deliver to GSK and external expectations.
• Interpersonal and communication skills to rapidly build trust with external and internal partners and ensure where difficult decisions are made, they are done so professionally with regards to GSK and GSK’s reputation.

Skills

Data Integrity, Detail-Oriented, Digital Fluency, Emergency Response, Financial Acumen, GxP Regulations, Lean Management, Manufacturing Processes, Problem Solving, Production Management, Project Coordination, Quality Compliance, Regulatory Compliance, Risk Awareness, Site Operations

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 - [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/