Manufacturing Specialist
King of Prussia, PA 
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Posted 13 days ago
Job Description
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Jan 14 2022

As Manufacturing Specialist, you 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 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 Manufacturing Specialist will support will follow the lifecycle of new products, more specifically: 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, and support the coaching and training of operators and associate 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 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.
  • 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. 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.

Why you?

Basic Qualifications:

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

  • Bachelor's Degree in Engineering, Microbiology, Biochemistry, Biotechnology, Computer
  • Science, Information Technology, Information Systems, Mathematics, or related field

  • Must be willing to work off-hours and weekends as needed

Preferred Qualifications:

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

  • 2+ years of experience in a related Manufacturing role within a Pharmaceutical manufacturing environment
  • GMP processing experience, exhibit skillset of supporting all aspects of production processing
  • Lab experience

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

*LI-GSK

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At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2+ years
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