QC Chemist III

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

The QC Chemist III is an experienced individual contributor responsible for the planning, execution, review, and coordination of Quality Control activities supporting incoming materials and packaging components at Gilead Sciences Ireland UC (GSIUC), Cork.

The role requires sound knowledge of Quality Control systems, analytical methods, specifications, and procedures and includes complex or non-routine assignments requiring scientific judgment, problem solving, and review of relevant data and factors.

Key responsibilities include:

• Comply with applicable Quality Management System, SOP, cGMP, data integrity, regulatory, and Environmental, Health and Safety requirements.
• Perform and coordinate the receipt, sampling, testing, review, and documentation of incoming materials and primary and secondary packaging components in accordance with approved specifications, procedures, sampling plans, and pharmacopoeial requirements.
• Review analytical data and test results for accuracy, completeness, data integrity, and compliance, and maintain records in applicable systems, including GLIMS/LIMS, LES, GVault/QDMS, and SAP.
• Coordinate testing and review activities to support manufacturing priorities, material need-by dates, packaging plans, and the timely disposition and release of materials and components.
• Lead or coordinate investigations into OOS, OOT, atypical results, deviations, data discrepancies, method or equipment issues, and material or component nonconformances, including root-cause analysis, impact assessment, and CAPA support.
• Prepare, review, and revise controlled technical documentation, including SOPs, methods, specifications, monographs, datasheets, protocols, investigation reports, qualification reports, and laboratory records.
• Support the introduction of new materials, packaging components, suppliers, grades, and part numbers through change control, technical assessment, method verification, qualification testing, specification updates, and system configuration.
• Coordinate contracted testing activities with approved external laboratories, including sample shipment, documentation, result review, and compliance with quality agreements.
• Provide technical guidance, training, and day-to-day support to colleagues, acting as a technical resource for assigned materials, components, methods, instruments, or laboratory processes.
• Maintain inspection readiness and support audits through accurate, complete, contemporaneous, and readily retrievable records.
• Drive continuous improvement and participate in cross-functional projects relating to materials, packaging components, analytical methods, laboratory systems, compliance, and operational excellence.
• Promptly escalate safety, quality, compliance, testing, and delivery risks, and collaborate effectively with relevant internal and external stakeholders.

Education & Experience

• Bachelor’s or Master's degree in Chemistry or a related scientific discipline with years of relevant experience.
• Pharmaceutical or biopharmaceutical industry experience preferred.
• Experience in GMP testing of materials or packaging components, analytical data review, laboratory investigations, technical documentation, and controlled laboratory systems is preferred.

Key Skills

• Strong knowledge of cGMP, data integrity, regulatory requirements, and applicable pharmacopoeias.
• Experience in material and packaging-component sampling, testing, documentation, disposition, and release support.
• Knowledge of relevant analytical techniques and instrumentation, including HPLC/UPLC; experience with FTIR, Raman, NIR, UV, GC, Karl Fischer, or packaging inspection is advantageous.
• Strong analytical data review, investigation, root-cause analysis, problem-solving, and technical-writing skills.
• Ability to work independently, manage competing priorities, and collaborate effectively across functions.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.