Senior Scientist, QC Position Available In Wake, North Carolina

Job Description:

Site Name:

USA

• North Carolina

•

ZebulonPosted Date:

May 82025Are you interested in working with cutting-edge laboratorytechnology to improve quality and accelerate regulatory compliance?

If so, this Senior Scientist QC role could be an excitingopportunity to explore.

As a Senior Scientist QC, you will ensurethat the QC testing of all products is performed to GMP and companystandards. This involves analytical Chemistry testing in aPharmaceutical Respiratory laboratory, analyzing samples,recording, evaluating and reporting data using prescribedprocedures with limited or no supervision.

This role will provideYOU the opportunity to lead key activities to progress YOUR career,these responsibilities include some of the following: Provide technical support and leadership pertaining toanalytical testing. Verify that results are accurate and complete.

Recognize deviations in analytical test procedures and SOP’s.

Evaluate product trends and perform analytical testing whennecessary. Coordinate and direct the use of laboratory resources to meetmanufacturing/packaging schedules, distribution and marketrequirements, stability commitments, and validation/processengineering initiatives. Assess the training needs of the staff to coordinate trainingas necessary. Release (approve/reject) analytical data from the laboratoryfor purposes such as manufacturing, product release to thecommercial market, and stability reporting. Serve as a site representative for specialized technology ininterdepartmental and international project teams (e.g., newproduct development, CAPs, USP). Review and provide input into the development of analyticalmethods, specifications, testing protocols, SOPs, and regulatorydocuments (NDAs, sNDAs, MAAs, etc.). Ensure compliance to regulated procedures. Troubleshoot methods and instrumentation. Participate/assist in laboratory investigations for out ofspecification or atypical results. Notify and participate with management and interdepartmentalteams concerning expanded investigations (external to thelaboratory). Why you?

Basic Qualifications:

We are looking forprofessionals with these required skills to achieve our goals: Bachelor’s degree in chemistry or other scientific degree and5+ years’ relevant pharmaceutical experience or master’s degree and2+ years’ pharmaceutical experience Experience of providing QC testing support to at least onevalue stream

Preferred Qualifications:

If you have the followingcharacteristics, it would be a plus: Knowledge/experience with internal and external audits (cGMPand FDA). Ability to lead and encourage continuous improvement. Operational knowledge of laboratory equipment, includingability to diagnose problems and identify appropriate actions e.g.

HPLC, GC, UV or FTIR Spectrometers. Full understanding of the requirements and application of GMPprinciples in a laboratory environment. Knowledge/experience in performing user acceptance testing forLIMS systems. Effective verbal and written communication on an individual andgroup basis targeted to appropriately audiences of several levelswithin GMS. Understanding of installation and validation of analyticalequipment. Understanding of validation and transfer of test methods. Developing leadership skills with an ability to form strongwin/win partnerships. A demonstrated willingness to collaboratewith colleagues to share best practices and /exchange ideas.

Supports other teams when required. Developing knowledge and application of the Quality ManagementSystem (QMS) Demonstrated ability to participate in product projects

• command of ICH guidance (ICHQ), GMP requirements and FDA/EMEAregulations.

Develop/design lab studies and protocols to beacceptable to regulators, as applicable Good understanding of products, data and statistical tools, tobe able to discuss and understand the state of the laboratory inrelation to the business metrics.

About the Zebulon Site GSK’sZebulon site is a global supplier of Respiratory and Solid Dosemedicines to patients around the globe and the largest GSKPharmaceutical secondary manufacturing site in North America. Thesite is located less than 30 minutes from downtown Raleigh,Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest. Keydifferentiators about

GSK and Zebulon:

Our commitment to inclusion is seen as a critical advantage ofours Our focus on cultivating a positive work environment that caresfor our employees Demonstrated opportunities for continued career growth drivenby individual ambition Leaders that care about their teams and growth of bothindividuals and the company A priority focus on Safety and Quality Clean and GMP compliant work environment Onsite cafeteria Onsite gym Temperature-controlled climate Licensed, onsite Health & Wellness clinic #LI-GSKPlease visitGSK US Benefits Summary to learn more about the comprehensivebenefits program GSK offers US employees. Why GSK? Uniting science,technology and talent to get ahead of disease together. GSK is aglobal biopharma company with a special purpose

• to unite science,technology and talent to get ahead of disease together
• so we canpositively impact the health of billions of people and deliverstronger, more sustainable shareholder returns
• as an organisationwhere people can thrive.

We prevent and treat disease withvaccines, specialty and general medicines. We focus on the scienceof the immune system and the use of new platform and datatechnologies, investing in four core therapeutic areas (infectiousdiseases, HIV, respiratory/ immunology and oncology).Our successabsolutely depends on our people. While getting ahead of diseasetogether is about our ambition for patients and shareholders, it’salso about making GSK a place where people can thrive. We want GSKto be a place where people feel inspired, encouraged and challengedto be the best they can be. A place where they can be themselves

• feeling welcome, valued, and included.

Where they can keep growingand look after their wellbeing. So, if you share our ambition, joinus at this exciting moment in our journey to get Ahead Together.

Ifyou require an accommodation or other assistance to apply for a jobat GSK, please contact the GSK Service Centre at 1-877-694-7547 (USToll Free) or +1 801 567 5155 (outside US).GSK is an EqualOpportunity Employer. This ensures that all qualified applicantswill receive equal consideration for employment without regard torace, color, religion, sex (including pregnancy, gender identity,and sexual orientation), parental status, national origin, age,disability, genetic information (including family medical history),military service or any basis prohibited under federal, state orlocal law.

Important notice to Employment businesses/ AgenciesGSKdoes not accept referrals from employment businesses and/oremployment agencies in respect of the vacancies posted on thissite. All employment businesses/agencies are required to contactGSK’s commercial and general procurement/human resources departmentto obtain prior written authorization before referring anycandidates to GSK. The obtaining of prior written authorization isa condition precedent to any agreement (verbal or written) betweenthe employment business/ agency and GSK. In the absence of suchwritten authorization being obtained any actions undertaken by theemployment business/agency shall be deemed to have been performedwithout the consent or contractual agreement of

GSK. GSK

shalltherefore not be liable for any fees arising from such actions orany fees arising from any referrals by employmentbusinesses/agencies in respect of the vacancies posted on thissite.

Please note that if you are a US Licensed HealthcareProfessional or Healthcare Professional as defined by the laws ofthe state issuing your license, GSK may be required to capture andreport expenses GSK incurs, on your behalf, in the event you areafforded an interview for employment. This capture of applicabletransfers of value is necessary to ensure GSK’s compliance to allfederal and state US Transparency requirements. For moreinformation, please visit the Centers for Medicare and MedicaidServices (CMS) website at https://openpaymentsdata.cms.gov/