Senior Production Specialist

Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals?  If so, this Senior Production Specialist opening could be an exciting opportunity to explore!

The Senior Production Specialist will be part of a high performing team responsible for delivering the supply of GSK products to the One Biopharm supply chain. They will demonstrate GSK Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) on a daily basis by engaging positively with team members and production support groups.

The Senior Production Specialist can be expected to lead pieces of work associated with supporting new product introduction (via the Tech Transfer Process) and/or improvement of existing processes.  The work this role will support will follow the lifecycle of new and existing products, more specifically: Technology Transfer, Commissioning & Qualification, Engineering/Clinical Batch manufacture, Process Performance Qualification batch manufacture, Commercial batch manufacture, Changeover, and Process/System Improvements.

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

• Demonstrate GSK Values – Our culture of Ambitious for patients, Accountable for Impact and Do the right thing are the foundations for how, together, we’ll deliver for our patients, shareholders and GSK people.
• Engage in cross functional teams, using operational knowledge, project management skills, and leadership ability to gain alignment on proposals to prioritize improvements that simplify both technical (equipment, biopharm processes) and business systems (quality systems, logistics, etc).  As a leader, ensures the team has appropriately prioritized these initiatives and is developing the capabilities to execute them.
• Understand production equipment and electronic systems in use (SAP, DeltaV, MES, IP21, etc) and P&ID diagrams of production equipment, as well as site quality processes (deviation, CAPA, change control).  Serve as technical experts for the production process and owners of production equipment, reviewers of automation/validation documentation, and support the coaching and development of operators and manufacturing specialists in these processes.
• Own interactions between the production team and other departments, understanding impact of their needs versus the production schedule. Balance the team’s ability to lead day to day operations with the consistent project management of programs and systems that need improvement over the long term.
• Adhere to safety procedures and training requirements in accordance with site, GSK, and federal regulations including the proper use of controls, personal protection equipment, and waste handling practices. Escalate equipment and processing issues that pose a safety or compliance risk.
• Follow ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles for all documentation of performed tasks. Own deviation investigations, write-ups, and management of corrective and preventative actions, impact assessments, and change controls (AL1, AL2). Interact with agency (FDA, EMEA, etc.) auditors when required. Can present the aforementioned quality documents in a regulatory inspection, and can support the sustainability of their quality over the long term.
• Schedule and track activities which (directly or indirectly) impact the schedule of manufacturing and/or required documentation.  Manage inventory of raw materials and single-use components, execute Batch Document revisions, and perform the role of Lead Investigator via the deviation management process.
• Identify and implement processing improvements in operations, improvement to quality systems and ways of working, and required documentation updates within the controlled systems of the site.  
• In support of technology transfer (TT), responsible for the authoring and/or review of key TT deliverables (e.g. batch documents, Process Transfer Documents (PTDs), Media/Buffer Trace Matrices, ERP Data Maintenance/Setup, Sampling Plans).
• Maintain accountability for deliverables adherence to Integrated Project Plan (IPP) in support of campaign certification. Engage within the TT Sub-team by providing input for decisions as well as present and lead discussions on relevant topics. Expectation is that during manufacturing campaigns, this role could spend up to 60% of time in the production suite supporting operations to ensure right first time (RFT) execution and gather feedback and understanding for potential process improvements/optimizations