Are you energized by driving process improvement and leveraging your technical expertise in a world class manufacturing environment?  If so, this Product Owner role could be an exciting opportunity to explore.

As the Product Owner you will provide technical leadership, guidance, oversight, and support for the associated product or product portfolio, through effective Product Lifecycle Management (PLM) and support for day-to-day operations, to ensure the ongoing manufacture and supply of our products in alignment with Regulatory and Quality standards and business objectives.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Provide technical input and support for product transfer, registration, validation and launch.

• Ensure that all aspects of Product Lifecycle Management are in place, actively maintained, and ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed. The key components of the PLM process include Development History, Material and Technical Risk Assessments, Product Specifications, Control Strategy, Performance Qualification and Continued Process Verification, Periodic Product Reviews, and Product Costing Standards.

• Translate the Control Strategy to the production floor such that Critical Raw Materials attributes, Critical Process Parameters, Critical Quality Attributes and Manufacturing controls are understood, appropriately challenged, agreed, verified, controlled and communicated.

• Perform GEMBAs in production and analytical testing to ensure that the relevant control and verification strategies are in place, in use and effective.

• Lead product failure investigations, escalating 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 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 that impact the technical performance of allocated products within manufacturing, packaging and testing.

• Provide technical input to regulatory submissions and responses to questions from regulatory agencies. Prepare technical documents, provide technical input and participate in regulatory inspections.

• Contribute to major technology development projects aligned to allocated products

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering.

• 5+ years' experience with pharmaceutical processes.

• Experience writing technical protocols and reports.

• Experience preparing for and delivering technical presentations to key stakeholders.

• Experience with investigational techniques and tools for process investigations

Preferred Qualifications:

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

• Post Graduate Degree.

• Working knowledge of the raw materials, equipment, unit operations and testing for Dry Powder Inhalers, Metered Dose Inhalers, or Oral Solid Dose, as appropriate to product.

• Basic understanding of the drug development process.  Experienced in scale-up and technology transfer.  Understanding of control strategy principles and application.

• Working knowledge of FMEA techniques.

• Knowledge of cGMPs related ICH guidance (specifically ICHQ8-11).

• Experienced with Product Lifecycle Management, including Control Strategies, Process Qualification, Change Control, and Technical Risk Assessment (L1 TRA Facilitator desired).

• Statistical knowledge and use of Statistica, JMP, SAS, or other data analysis software

• 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 

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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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