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.GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by the state or local law and where vaccine supply is readily available. GSK employees working in Montana are excluded from the Company mandate per House Bill 702.
Your responsibilities include some of the following:
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
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
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
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
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?Basic Qualifications:
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
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
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.
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).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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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