Scientist I, QC Technical Resources

Nova Pneuma, Inc.; Fremont (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Nova Pneuma, Inc. in Fremont, California, is seeking a Quality Control Scientist to provide scientific and operational support. You will oversee the stability program, perform cGMP pharmaceutical testing, and ensure compliance with regulations. The ideal candidate has a BS in a related field, with a minimum of 8 years in a GMP-regulated QC lab. Responsibilities include developing protocols, trend analysis, and authoring technical documents. Strong knowledge of GMP regulations and analytical methods is essential.

Qualifications

• Minimum of 8 years of experience in GMP-regulated QC laboratory, preferably in pharmaceuticals or biotech.

Responsibilities

• Develop and maintain stability protocols, reports, and other related documentation.
• Manage stability chambers and ensure timely testing and reporting.
• Trend stability data and support investigations related to stability samples.
• Author and review QC SOPs and technical documentation.
• Conduct investigations and implement corrective actions.
• Develop, validate, and transfer analytical methods and troubleshoot instruments.
• Train and mentor junior analysts and interface with clients.

Skills

GMP regulations knowledge

Empower and OpenLab chromatography software

Stability program requirements (ICH Q1A–Q1E)

Data integrity principles

Organizational skills

Documentation and communication skills

Method validation

Data analysis

Regulatory guidelines familiarity

Multi-tasking ability

Detail-oriented data skills

Experience with WORD and EXCEL

Education

BS in Chemistry, Biochemistry, Analytical Chemistry or related field

Job description

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 Summary

Provides 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.

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.

Skills required

• 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

Education and experience

• 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

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times