QC Technical Resources Scientist I

Responsibilities

• Develop 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 samples.
• Author, review, and revise QC SOPs, test methods, and technical documentation.
• Document and maintain risk assessment reports in accordance with quality standards.
• Conduct 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.

Requirements

• Deep 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 judgement.
• Excellent data analysis skills with attention to detail and interpretation of results.
• Excellent written and oral communication skills.
• Experience with computer software such as WORD, EXCEL and chromatographic workstation systems.

Qualifications

• BS in Chemistry, Biochemistry, Analytical Chemistry or related field.
• Minimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotech.

Skills

• Deep 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).
• Experience with computer software such as WORD, EXCEL and chromatographic workstation systems.

Benefits

Nova Pneuma offers a competitive compensation package, comprehensive benefits, and a supportive work environment that fosters innovation and growth.

Pay

The salary range for this position is $70,000 - $90,000 annually, commensurate with experience.

Schedule

The position is full-time and works a standard Monday through Friday schedule.