Job Description

Are you looking for an opportunity to manage the delivery of MSAT products?  If so, this is the role for you.

As Product Owner, you will be responsible for owning and providing technical leadership for a product or product family at the Marietta site and to ensure that the product is delivered to the highest levels of quality, robustness, safety and sustainability. This includes managing and delivering the project portfolio, including new product introduction and complex changes to existing products, processes, and equipment technologies and also to 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:

• Technical Leadership:
• Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance, and end-to-end process, including critical quality attributes (CQAs), critical process parameters (CPPs), manufacturing process parameters (MPPs) and sustainability aspects. Accountable at site level for maintaining this knowledge and sharing on site and globally, as appropriate.
• Responsible for scientific and product related decisions for which technical training is required and provide technical input and support for product transfers, registration, validation, and launch.
• Product Lifecycle Management
• Maintain accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications and ensure risks are identified and escalated as appropriate, and mitigation plans are in place and agreed within appropriate quality systems (e.g., CAPAs or governance boards).
• Ensure all aspects of QbD principles are applied and Product Lifecycle Management (PLM) are in place, actively maintained, documented in planned dates and shared at the appropriate levels through leading, facilitating and reviewing: Technical Risk Assessment (TRA), Product Control Strategy (PCS with translation to standard work as batch manufacturing instructions), Continued Process Verification and Process Robustness Assessment.
• Ensure product performance data trending is in place to identify and investigate adverse 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.
• Process Improvement
• Lead process improvement projects on-site, ensuring appropriate technical change control to deliver robust, sustainable solutions with cross-functional teams to evaluate and implement post-approval changes and drive improvements in product control and robustness.

• Regulatory and Compliance

• Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews (PPRs), and internal and external audits and ensure compliance with regulatory requirements and GSK standards.

• Root Cause Analysis

• Provide technical leadership and input into root cause analyses to support the investigation and resolution of product complaints, deviations and manufacturing challenges, in conjunction with QA and operations.
• Training and Development
• Identify, develop, and train successors for the role, and coach others in his/her area of expertise and ensure other functions (e.g., operations) have sufficient product knowledge and understanding to execute their roles.
• Stakeholder Management/Communication
• Establish key relationships within the site across MSAT, Operations, Quality, Engineering and EHS for the product(s) for which he/she is accountable, and above site with other Product Owners, Stewards and R&D and lead the technical discussion with internal & external stakeholders at various forums like Global Product Technical Review Team (gPTRT), project steering meetings, Vaccine Technical Council, change control.
• Other
• Ensure that EHS, Sustainability and GPS are supported.

Why you?

Basic Qualifications:

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

• Bachelor’s degree of Science
• Minimum of 5 years in vaccine pharmaceutical process experience, preferably a multinational one.
• Minimum of 5 years' experience with investigational techniques, tools for process investigations and trouble shootings.

Preferred Qualifications:

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

• Master’s degree or other advanced degree
• Demonstrated experience in the Vaccine Pharmaceutical industry in leading the technical aspects of the Product Lifecycle including Scale Up, Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, Process/Cleaning validation, Contamination Control and change control.
• In-depth knowledge and understanding of vaccine’s raw materials, single use system, filtration, homogeneity, complexation, buffer preparation, formulation, aseptic filling, automated visual inspection and testing.
• Excellent technical writing and oral communication skills.
• Ability to navigate critical business systems and databases (e.g., MERP, IP21) and mine relevant data for reporting, review, and analysis.
• Statistical knowledge to assess/interpret statistical data (e.g. process capability, control charts, DoE, MSA) and use of Statistica, JMP, SAS, PBI or other data analysis software
• Familiar with risk-based approaches and use of data to design process performance qualification strategies.
• Thorough knowledge of cGMP and related guidelines (specifically ICHQ8-11) particularly in markets where product is commercialized and good understanding EHS requirements.
• Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions, and senior stakeholders.
• Basic understanding of the drug development process.
• Excellent project management skills.

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Please visit  GSK US Benefits Summary t o 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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