Senior Product Owner

GSK•Zebulon, NC

8d•Hybrid

About The Position

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.

Requirements

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)

Nice To Haves

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.

Responsibilities

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.