QC Technical Resources Scientist I

Welcome to Nova Pneuma — a company built on innovation and a shared commitment to creating meaningful medicines for patients in need. Innovation requires bold thinking and the courage to persevere despite setbacks, criticism, and uncertainty. We believe in providing our employees with a purpose centered on innovation, along with the freedom to take thoughtful risks in pursuit of creative ambition. By fostering a culture of curiosity, collaboration, and resilience, we create the foundation for both scientific breakthroughs and long-term value for our company.Job SummaryProvides scientific, technical, and operational support to the Quality Control organization while coordinating all aspects of the site’s stability program. Conducts cGMP pharmaceutical testing to ensure regulatory compliance and safety. Assists in method transfers, verifications, and qualifications activities.ResponsibilitiesDevelop and maintain stability protocols, reports, and other related documentation to support the stability program.Manage stability chambers, including qualification, monitoring, and capacity planning.Ensure timely pull points, testing, data review, and reporting for all stability studies.Trend stability data, identify OOT/OOS signals, and support investigation related to stability samplesAuthor, review, and revise QC SOPs, test methods, and technical documentationDocument and maintain risk assessment reports in accordance with quality standardsConduct or participate in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, root cause analysis and implementing Corrective/Preventive Actions (CAPA).Author, review, and approve technical documents, SOPs, and reports, ensuring adherence to FDA/EMA and cGMP regulations.Develop, validate, and transfer analytical methods as needed, troubleshoot instrumentation such as HPLC, UPLC and GC.Train and mentor junior analysts, and interface with clients or regulatory authorities. Skills requiredDeep knowledge of GMP regulations and advanced laboratory techniques.Strong Knowledge of in Empower and OpenLab chromatography software.Strong understanding of stability program requirements (ICH Q1A–Q1E).Familiarity with GMP, data integrity principles, and regulatory expectations.Strong organizational skills and ability to manage multiple studies and timelines.Excellent documentation, communication, and cross-functional collaboration abilities.Knowledge of method validation or lifecycle management.Ability to analyze data trends and contribute to technical investigations.Familiarity with regulatory guidelines (ICH, FDA, EMA)Maintain audit‑ready documentation and support internal and external inspections.Well-organized, capable of multi-tasking and working on complex problems with sound scientific judgementExcellent data analysis skills with attention to detail and interpretation of resultsExcellent written and oral communication skillsExperience with computer software such as WORD, EXCEL and chromatographic workstation systemsEducation and experienceBS in Chemistry, Biochemistry, Analytical Chemistry or related fieldMinimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotechPhysical RequirementsProlonged periods of sitting at a desk and working on a computerPotentially prolonged periods standingMust be able to lift up to 15 pounds at times