The Senior Manufacturing Associate, as part of a team of manufacturing employees, supports the start-up, definition of procedures, manufacturing of consistency batches, and sustained production of QS-21. This includes seeing a batch from raw materials to final shipped product, including, manual manipulations, automated manufacturing, cleaning of the facility, and review batch records.

Your responsibilities include some of the following:

Safety:

• Support and promote the overall site goal of Safety First

• Responsible for application of GSK safety and environmental guidelines and act as a role model within the department

• Ensure all job responsibilities adhere with applicable regulations, current operating procedures and industry practice

• Identify and help mitigate EHS and safety risks

Process & Technical:

• Working with technical production equipment (e.g. HPLC and Lyophilizer); this includes interfacing with DeltaV automation to run the production equipment

• Lead/support validation related to equipment, cleaning, and manufacturing processes

• Experience and competence in troubleshooting equipment and automation

• Perform manual operations including set-up/breakdown of filtration skids, filling/loading of lyophilization trays, loading equipment for cleaning, and routine sampling

• Adherence to Good Documentation Practices as part of batch execution

• Ability to take ownership and accountability of their process/batch as they see it from raw material through final bulk packaging

Communication & Teamwork:

• Excellent communication skills (written and verbal) within the team and across departments

• Supports cross-functional communication and the GSK quality mindset by proactively identifying and reporting compliance issues to area supervisor and QA

• Actively participates in a high performing team, able to demonstrate initiative

• Ability to collaborate as part of a team and effectively work across boundaries including coordination with different departments

Technical Writing:

• Drafting and revising Standard Operating Procedures

• Drafting and leading Change Controls for modifications to the procedures and processes

• Deviation writing, including root cause investigation and corrective action creation

Automation:

• Perform and monitor manufacturing processes using a highly automated approach based upon Emerson's Delta V platform

• Troubleshoot process deviations resulting from automation communication issues

• Assemble batch reports using Emerson Delta V and OSI PI historian

Behavioral:

• Ability and drive to work independently toward completion of objectives per schedule

• Ensure all activities are executed following Quality and regulatory standards

• Participate in and support continuous improvement and performance management initiatives

• Drive and support GPS (GSK Production System) principles and initiatives

• Demonstrate a continuous improvement mindset to drive business impact

• Adhere to GSK values and expectations including: Patient Focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork

• Represent GSK with the highest level of integrity and professionalism

• Ability to maintain confidentiality of sensitive information

• Adhere to GSK policies and procedures and support management decisions and goals in a professional manner

• Show awareness of changing schedules, request and priorities put forth by management

General:

• Adhere to GSK policies, procedures and support site goals

• Participate in and support continuous improvement and performance management initiatives

• Recognize technical issues and relay to supervisor

• Perform duties as assigned with respect to quality, timeliness, quantity and cost

Why you?

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

• 3+ years of cGMP experience with a Bachelor's Degree in any discipline

or

• 6+ years of cGMP experience with High School Diploma or GED

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

• Experience with HPLC, UFDF, Lyophilizer, and DeltaV Automation

• Knowledge of hazardous waste handling procedures from production activities to satellite storage areas

• Experience in participation in RCA (Root Cause Analysis) for EHS incident and deviations

• Ability to maintain site in a state of inspection readiness

• Ability to handle safety and quality related CAPA tasks

• Ability to work collaboratively, as well as independently, with minimal supervision

• Ability to handle multiple priorities and requests from various departments

• Ability to independently operate production equipment per appropriate procedures

• Ability to participate in all aspects of team functions

• Ability to write and revise procedures/protocols and other pertinent documentation

*LI-GSK

#LI-GSK

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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.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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