Associate Manufacturing Specialist

GSK is currently looking for an Associate Manufacturing Specialist to join our team in Upper Merion, PA. The Associate 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 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 associate manufacturing specialist, with support from team leads and supervisors, 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 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.

KEY RESPONSIBILITIES

• 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.
• 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.
• Understand production equipment systems in use and P&ID diagrams of production equipment. Serve as technical experts for the production process and owners of production equipment.
• Follow ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) principles for all documentation of performed tasks. Own Commissioning/Qualification/Validation protocols, deviation investigations, writeups, and management of corrective and preventative actions.
• Support delivery of key product lifecycle deliverables from various functional groups (Production, Engineering, Technical, Validation, etc.) for new, or changes to existing, equipment and processes. Draft, review and/or execute documents and protocols (i.e. component/system assessments, specifications, equipment testing, ERP data collection, SOPs, batch documents, equipment or process qualification). Own and manage Deviations, CAPAs, and AL1/AL2 change controls.
• 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 process improvements (i.e. reduce material waste, improve productivity) and required documentation updates, within the controlled systems of the site. Own production area metrics as part of the GSK Production System.
• The associate manufacturing specialist may be responsible for availability as on-call personnel, remotely monitoring, and working occasional weekend or night coverage as needed.

Basic Qualifications:

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

• BS/BA degree
• 1+ year of GMP experience in biopharma/pharma manufacturing

Preferred Qualifications:

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

• Strong DeltaV, SAP, Syncade and Aspen IP21
• Knowledge of cGMPs and their relationship to statistical methods.
• Strong communications skills.
• Project and priority management.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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