This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Adhere to all EHS policies. Promote Safety culture by on-time reporting of incidents, and identification of ZAPS and HAZ IDs.

• Perform cGMP testing of utilities, bulk/finished products, and validation samples utilizing established methods. Examples of test types include ELISA, uPLC/HPLC, SRD, TOC, FTIR, KF, Conductivity, Nitrates, Silicone Homogeneity, Diluent Testing may occur on first and second shifts and may include weekend and/or holiday work.

• Provide accurate results and interpret data in compliance with cGMP’s, procedures and all applicable regulations. Follow up on questionable results and notify QC Biochemistry Supervisor in a timely manner.

• Ensure all equipment, supplies and reagents are available and in a GMP state to support testing that is right-first time and on time. Execute reagent, standard qualifications as required.

• Perform data review and logbooks reviews.

• Be SME for Biochemistry tests/processes. Work collaboratively to benchmark across the network and optimize processes to incorporate GSK best practices, incorporate efficiency, and address regulatory gaps. Serve as SME during internal and external audits.

• Serve as project manager for Biochemistry/QC projects. Work to identify tasks, schedules, and budget for project, and execute to plan. Provide routine updates on project status.

• Conduct analyst qualification/training of team.

• Participate in investigations and planned remedial actions for atypical events and/or results in order to support the timely resolution of investigations. Author associated documentation.

• Write, update, and review Laboratory Standard Operating Procedures, Analytical Methods, Specifications and other GMP documents. Execute validation protocols and reports and other equipment-related documents.

• Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations. Maintain required records and logs.

• Carry out departmental duties as deemed appropriate by Supervisor/ Manager.

Why you?

Basic Qualifications:

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

• Bachelor's of Science in Biochemistry, Chemistry, Microbiology, or similar scientific discipline.

• Minimum 1 year experience in a GMP/FDA regulated environment.

• Minimum 1 year experience in Quality Control environment in a microbiology/chemistry/biochemistry field.

Preferred Qualifications:

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

• Bachelors of Science in Biochemistry, Chemistry, Microbiology or similar scientific discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.

• Technical expertise in a scientific discipline would enable a candidate to better understand testing techniques/methods and ensure accuracy of result generation in verifying safety, quality, purity and potency of the produced material.

• Ability to take responsibility for understanding GMP testing processes and confirming that testing complies with regulatory requirements, GSK’s quality management system and GSK specifications.

• Able to prioritize and decide appropriate course of action and to effectively implement decisions.

• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.

• Training and work experience in data analysis in order to monitor and trend data preferred.

• Sense of urgency, flexibility and accountability.

• Must be a committed team player prepared to work in and embrace a team-based culture.

• Intermediate computer skills required.

• Stay current on developments in the field and GSK-Bio Standards.

• Maintain attention to detail, while completing multiple or repetitive tasks.

• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.

• Willing to travel abroad for training purposes.

• Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; over-time may be required.

• Ability to take responsibility for performing microbiological testing, which is utilized to make release decisions for commercial product and for confirming that the testing complies with regulatory requirements, GSK’s quality management system and GSK specifications.

• Prior work experience and/or able to perform some or all of the following: ELISA, uPLC, HPLC, STOC, FTIR, KF, Conductivity, Wet Chemistry.

• Versed in GMPs, FDA and other regulatory agency requirements. Ability to interface with regulatory auditors.

• Serve as an SME (subject matter expert) in technical areas in order to provide information to others.

• Prior experience using the United States Pharmacopoeia (USP) for QC testing guidance.

• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write documentation as necessitated by regulatory agencies and internal policy.

• Ability to establish and maintain working relationships with Site staff and the ability to analyze data and implement changes.

• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment. Ability to work in a high complex matrix environment.

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Why GSK?

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 organization 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 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.

“US work authorization is required for this role. Sponsorship is not available for this position.”

• This is a job description to aide in the job posting, but does not include all job evaluation details.