Senior Product Owner

Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary
The Senior Product Owner works with great independence, manages increased complexity, serves as a technical resource to the broader team, and drives strategic changes to improve performance of product portfolios to ensure ongoing manufacture and supply of our products in alignment with Regulatory and Quality standards and business objectives.

This role is a key addition to support the new specialty medicine assembly and pack hub at GSK Zebulon.

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

• Deliver Product Owner responsibilities with a high degree of independence by providing technical input and support for sterile injectable product transfers, registration, validation and launch and ensuring all aspects of Product Lifecycle Management are in place and actively maintained, risks are identified and escalated as appropriate, and mitigation plans are in place and agreed.
• Translate the Control Strategy to the production floor such that Critical Raw Materials attributes, Critical Process Parameters, Critical Quality Attributes and Manufacturing controls for sterile injectable products are understood, appropriately challenged, agreed, verified, controlled and communicated.
• Independently lead product failure investigations, including complex investigations using advanced techniques. Escalate significant issues to ensure appropriate support and expertise are provided. Trend product performance data, identify and investigate trends and concerns, and communicate to key
• stakeholders. Present product performance data to the relevant governance meetings (e.g. Product Technical Review Team (PTRT), Communities of Practice, and provide input to PPR for assigned products.
• Lead risk assessments as required for changes and/or periodic review and lead cross-functional teams to evaluate and implement post-approval changes and drive improvements in product control and robustness.
• Work with the supply chain (including primary, excipient and/or component suppliers) to manage inputs and drive strategic improvements to optimize the technical performance of sterile injectable products, especially pre-filled syringes, within assembly, packaging and testing.
• Serve as sterile injectable technical expert at the site and within the network. Liaise closely with other Product Owners to ensure learnings and best practices are captured and embedded in improved ways of working.
• Serve as a dosage form technical expert at the site and within the network. Liaise closely with other Product Owners to ensure learnings and best practices are captured and embedded in improved ways of working.
• Develop and implement strategic changes to enhance capabilities for data acquisition and trending of raw materials, process parameters and product performance.
• Engage and influence key personnel across the entire value chain, including Quality, regulatory affairs, R&D, relevant primary or secondary manufacturing sites, Manufacturing Strategy.

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 engineering, pharmaceutical sciences, chemistry, biology or related scientific discipline.
• 5+ years' experience in pharmaceutical or biopharmaceutical manufacturing, process development, MSAT or technical operations, with a focus on sterile injectables, especially pre-filled syringe and auto injector formats.
• Experience with complex investigational techniques and analysis tools.
• Experienced with Product Lifecycle Management, including Control Strategies, Process Qualification, Change Control and Technical Risk Assessments.
• Required experience working with raw materials, equipment, unit operations and testing for sterile injectables, especially pre-filled syringe and auto injector formats.
• Technical Risk Assessment (L1 TRA Facilitator desired)

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

• Advanced degree in a relevant scientific or engineering field.
• Basic understanding of the drug development process.
• Experience with technology transfer, scale-up, or commercial launch activities, with strong preference for experience supporting tech transfer for sterile injectables, pre-filled syringe, and auto injector products.
• Statistical knowledge and use of Statistica, JMP, SAS, or other data analysis software.
• Experience leading multidisciplinary teams and projects for continuous improvement, troubleshooting, implementation of changes and technology enhancement programs.
• Ability to actively engage and influence key personnel across the entire value chain, including Quality, regulatory affairs, R&D, relevant primary or secondary manufacturing sites
• Experience with the application of global quality procedures, validation principles and regulatory requirements.
• Working knowledge of Good Manufacturing Practice (GMP) and relevant regulatory expectations.
• Excellent technical writing and oral communication skills.
• Excellent project management skills.
• Ability to navigate critical business systems and databases (e.g. MERP, IP21) and mine relevant data for reporting, review and analysis.
• Familiar with risk-based approach and use of data to design a process qualification strategy, including the selection of batches and development of sampling plans.
• Familiar with cleaning validation approach as it relates to manufacturing operations and limitations.

About the Zebulon Site

GSK's Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest.


Key differentiators about GSK and Zebulon:

• Our commitment to inclusion is seen as a critical advantage of ours
• Our focus on cultivating a positive work environment that cares for our employees
• Demonstrated opportunities for continued career growth driven by individual ambition
• Leaders that care about their teams and growth of both individuals and the company
• A priority focus on Safety and Quality
• Clean and GMP compliant work environment
• Onsite cafeteria
• Onsite gym
• Temperature-controlled climate
• Licensed, onsite Health & Wellness clinic

Working arrangement
This role is hybrid. You will be expected to work on-site regularly to support transfers, validations and manufacturing interactions, with flexibility for remote work as agreed with your manager.

Our approach
We welcome people with different backgrounds and perspectives. We seek curious, reliable and collaborative colleagues who want to make a real difference to patient outcomes. If this role matches your skills and ambitions, we encourage you to apply and tell us how you would contribute.

#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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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.

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