Manufacturing Specialist

GSK•King of Prussia, PA

About The Position

The Manufacturing 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 Culture (Ambitious for Patients, Accountable for Impact, and Do the Right Thing) on a daily basis by engaging positively with team members and production support groups. The manufacturing specialist, with support from the senior specialist and/or production manager, will perform a mix of tasks ranging from operation of GMP equipment, to leading pieces of work associated with supporting new product introduction and/or improvement of existing processes. The work this role can support includes Equipment/Facility Design, Technology Transfer, Commissioning & Qualification, Start-up & Engineering Batch manufacture, Process Performance Qualification batch manufacture, Clinical Supply, Commercial Supply, Changeover, Process Improvement. 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 – Patient Focus, Transparency, Respect, and Integrity – in every interaction, in every work task, and with every responsibility of the job role. Live GSK’s Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace. Engage in cross functional teams, using operational knowledge and project management skills 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 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. 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 simple change controls. Interact with agency (FDA, EMEA, etc.) auditors when required. 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 through the use of Enterprise Resource Planning (ERP) systems at site. For new product introduction (NPI) - During Engineering, PPQ, Clinical or Commercial manufacturing campaigns: train on and perform GMP operations in the seed lab (aseptic processing), cell culture, media and buffer prep, equipment prep, purification, and final fill (aseptic processing) production areas based on standard operating procedures (SOPs) and digitalized technologies. Support the coaching and training of operators and associate specialists in these processes. Expectation is that during manufacturing campaigns, this role spends up to 80% of time in the production suite, supporting operations directly as needed. 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. The manufacturing specialist will be responsible for availability as on-call personnel, remotely monitoring, and working during weekend coverage and some night coverage as needed.

Requirements

Bachelor’s degree in a scientific discipline
2+ years of experience in a Good Manufacturing Practices (GMP) environment.

Nice To Haves

Working knowledge of quality systems: deviation, CAPA, change control, and control documentation demonstrated ability to work in a collaborated work environment

Responsibilities

Demonstrate GSK Values – Patient Focus, Transparency, Respect, and Integrity – in every interaction, in every work task, and with every responsibility of the job role.
Live GSK’s Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.
Engage in cross functional teams, using operational knowledge and project management skills 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 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.
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 simple change controls.
Interact with agency (FDA, EMEA, etc.) auditors when required.
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 through the use of Enterprise Resource Planning (ERP) systems at site.
For new product introduction (NPI) - During Engineering, PPQ, Clinical or Commercial manufacturing campaigns: train on and perform GMP operations in the seed lab (aseptic processing), cell culture, media and buffer prep, equipment prep, purification, and final fill (aseptic processing) production areas based on standard operating procedures (SOPs) and digitalized technologies.
Support the coaching and training of operators and associate specialists in these processes.
Expectation is that during manufacturing campaigns, this role spends up to 80% of time in the production suite, supporting operations directly as needed.
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.
The manufacturing specialist will be responsible for availability as on-call personnel, remotely monitoring, and working during weekend coverage and some night coverage as needed.