Senior Product Owner
GSK
15 days ago
Remote friendly (Zebulon, NC)
United States
IT
Responsibilities:
- Deliver Product Owner responsibilities for sterile injectable product transfers, registration, validation, and launch; ensure Product Lifecycle Management is maintained; identify/escalate risks and agree mitigation plans.
- Translate the Control Strategy to the production floor by ensuring Critical Raw Materials attributes, Critical Process Parameters, Critical Quality Attributes, and manufacturing controls for sterile injectables are understood, challenged, agreed, verified, controlled, and communicated.
- Independently lead product failure investigations using advanced techniques; escalate significant issues; trend product performance data and communicate findings to stakeholders; present data at governance meetings (e.g., PTRT/Communities of Practice) and provide input to PPR for assigned products.
- Lead risk assessments for changes/periodic review; lead cross-functional teams to evaluate/implement post-approval changes and improve product control and robustness.
- Partner with supply chain (primary/excipient/component suppliers) to optimize technical performance of sterile injectables (especially pre-filled syringes) across assembly, packaging, and testing.
- Serve as sterile injectable technical expert and dosage form technical expert at the site and network; capture and embed learnings/best practices with other Product Owners.
- Develop/implement strategic changes to enhance data acquisition and trending of raw materials, process parameters, and product performance.
- Engage and influence personnel across the value chain (Quality, regulatory affairs, R&D, primary/secondary manufacturing, Manufacturing Strategy).
Qualifications:
- Bachelor’s degree in engineering, pharmaceutical sciences, chemistry, biology, or related.
- 5+ years in pharmaceutical/biopharmaceutical manufacturing, process development, MSAT, or technical operations focused on sterile injectables, especially pre-filled syringe and auto injector formats.
- Experience with complex investigational techniques and analysis tools.
- Product Lifecycle Management experience (Control Strategies, Process Qualification, Change Control, Technical Risk Assessments).
- Technical Risk Assessment (L1 TRA Facilitator desired).
Preferred Qualifications:
- Advanced degree; drug development process knowledge.
- Experience with technology transfer, scale-up, and/or commercial launch (sterile injectables preferred).
- Statistical/data analysis tools (Statistica, JMP, SAS, etc.); leading multidisciplinary continuous improvement/troubleshooting projects.
- Global quality procedures, validation principles, regulatory requirements; GMP knowledge.
- Strong technical writing and oral communication; project management.
- Experience using business systems/databases (e.g., MERP, IP21); risk-based process qualification strategy and sampling plans; cleaning validation familiarity.
- Deliver Product Owner responsibilities for sterile injectable product transfers, registration, validation, and launch; ensure Product Lifecycle Management is maintained; identify/escalate risks and agree mitigation plans.
- Translate the Control Strategy to the production floor by ensuring Critical Raw Materials attributes, Critical Process Parameters, Critical Quality Attributes, and manufacturing controls for sterile injectables are understood, challenged, agreed, verified, controlled, and communicated.
- Independently lead product failure investigations using advanced techniques; escalate significant issues; trend product performance data and communicate findings to stakeholders; present data at governance meetings (e.g., PTRT/Communities of Practice) and provide input to PPR for assigned products.
- Lead risk assessments for changes/periodic review; lead cross-functional teams to evaluate/implement post-approval changes and improve product control and robustness.
- Partner with supply chain (primary/excipient/component suppliers) to optimize technical performance of sterile injectables (especially pre-filled syringes) across assembly, packaging, and testing.
- Serve as sterile injectable technical expert and dosage form technical expert at the site and network; capture and embed learnings/best practices with other Product Owners.
- Develop/implement strategic changes to enhance data acquisition and trending of raw materials, process parameters, and product performance.
- Engage and influence personnel across the value chain (Quality, regulatory affairs, R&D, primary/secondary manufacturing, Manufacturing Strategy).
Qualifications:
- Bachelor’s degree in engineering, pharmaceutical sciences, chemistry, biology, or related.
- 5+ years in pharmaceutical/biopharmaceutical manufacturing, process development, MSAT, or technical operations focused on sterile injectables, especially pre-filled syringe and auto injector formats.
- Experience with complex investigational techniques and analysis tools.
- Product Lifecycle Management experience (Control Strategies, Process Qualification, Change Control, Technical Risk Assessments).
- Technical Risk Assessment (L1 TRA Facilitator desired).
Preferred Qualifications:
- Advanced degree; drug development process knowledge.
- Experience with technology transfer, scale-up, and/or commercial launch (sterile injectables preferred).
- Statistical/data analysis tools (Statistica, JMP, SAS, etc.); leading multidisciplinary continuous improvement/troubleshooting projects.
- Global quality procedures, validation principles, regulatory requirements; GMP knowledge.
- Strong technical writing and oral communication; project management.
- Experience using business systems/databases (e.g., MERP, IP21); risk-based process qualification strategy and sampling plans; cleaning validation familiarity.