Senior Specialist, Quality Control, Chemistry

Role Summary

In this individual contributor role, you will play a critical part in ensuring the quality, integrity, and compliance of QC Chemistry activities supporting release and stability testing across our mRNA portfolio. You will combine deep analytical expertise with a strong quality mindset to review complex cGMP data, support laboratory operations, and continuously improve quality systems.

• Perform cGMP Quality Control data review for QC Chemistry, including release and stability testing, while supporting Method Qualification and Acquisition activities as required.
• Support method transfers and method development activities to ensure robust analytical capabilities.
• Review executed assay packages in both paper and electronic formats, including chromatography data and other analytical outputs.
• Ensure laboratory testing is performed accurately and in full compliance with cGMP, GDP, Data Integrity, and Good Documentation Practices requirements.
• Perform activities required to maintain GMP compliance across QC laboratory operations.
• Support stability program activities, including review of stability data packages and associated documentation.
• Perform data entry activities and support laboratory data trending.
• Lead troubleshooting activities for analytical methods and laboratory equipment.
• Participate in cross‑functional planning activities to align QC resources and laboratory constraints with business objectives.
• Support and mentor junior team members through technical guidance, troubleshooting, and training.
• Author, review, and approve SOPs, analytical test methods, QC release documentation, instrument qualification documentation, computer system validation documentation, training materials, and method lifecycle documentation as required.
• Develop and manage scheduling and status monitoring tools to track testing capacity, turnaround times, and communicate laboratory progress across the organization.
• Provide compliance guidance and support to the QC Chemistry team, including preparation for, participation in, and response to internal and external compliance audits.
• Perform and/or support Certificate of Analysis generation and preparation of stability data packages.
• Complete, review, and maintain cGMP documentation supporting all laboratory activities.
• Lead Quality System records, including investigations, Out of Specification (OOS) events, deviations, change controls, and Corrective and Preventive Actions (CAPAs).
• Execute work precisely in accordance with internal procedures, Standard Operating Procedures (SOPs), work instructions, and applicable GxP regulations.
• Ensure documentation, records, and laboratory data are audit‑ready and maintained to support regulatory inspections.
• Support special projects that contribute to continuous improvement, operational excellence, and laboratory innovation.
• Collaborate with colleagues across Quality, Manufacturing, and Technical Development to deliver high‑quality analytical support while embracing emerging digital technologies, including opportunities to leverage Generative AI tools where appropriate to improve efficiency and knowledge sharing.

• BA/BS in Chemistry (preferred) or other relevant scientific discipline.
• +5 years experience in quality control laboratory of a pharmaceutical company.
• Experience with analytical chemistry review including chromatographic techniques—HPLC, UPLC, spectroscopic and spectrometric techniques; physical properties techniques such as Particle Analysis by Dynamic Light Scattering and others.
• Working experience in a GMP environment.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations (preferred).
• Ability to collaborate effectively in a dynamic, cross‑functional matrix environment.
• Ability to efficiently prioritize and complete multiple projects and tasks in a fast‑paced environment.
• Working proficiency in English, minimum C1 level required.

• Competitive healthcare.
• Voluntary benefit programs to support your unique needs.
• Holistic approach to well‑being with access to fitness, mindfulness, and mental health support.
• Family building benefits, including fertility, adoption, and…