What are the responsibilities and job description for the GMP QC Scientist position at BrainXell Therapeutics Global?
Overview
The GMP QC Scientist is a position responsible for performing and reviewing advanced analytical testing to ensure clinical product quality, regulatory compliance, and adherence to GMP standards. This role requires strong hands-on experience with iPSC-derived cell products, mammalian cell culture, Flow Cytometry, and ddPCR along with expertise in molecular assays and troubleshooting. The GMP QC Scientist contributes to method validation, technology transfer, Out-of-Specification (OOS) investigations, and continuous improvement initiatives while collaborating across functions to meet clinical product release goals.
Key Responsibilities
- Perform routine and complex GMP clinical product release QC testing with emphasis on iPSC-derived cells, mammalian cell culture, Flow Cytometry, and ddPCR in compliance with GMP requirements.
- Execute and troubleshoot advanced analytical methods including but not limited to Flow, ddPCR, and other molecular assays.
- Support method validation, qualification, and technology transfer under GMP guidelines.
- Maintain QC equipment in compliance with GMP requirements.
- Review and approve laboratory data for accuracy, completeness, and regulatory compliance.
- Lead and support investigations of Out-of-Specification (OOS) results and deviations, including root cause analysis and CAPA implementation.
- Ensure laboratory practices, documentation, and records are maintained in accordance with GMP standards.
- Collaborate with cross-functional teams (e.g. Manufacturing, QA, AD, and R&D) to meet product release deadlines and resolve technical issues.
- Identify opportunities for workflow and process improvements and assist in their implementation.
- Prepare, present, and maintain technical reports, summaries, and GMP documentation.
- Perform routine environmental monitoring (EM) in the Clean Environment Area (CEA) and prepare routine EM tracking and trending reports as needed.
Qualifications and Experience
Bachelor’s degree in Biochemistry, Microbiology, Molecular Biology, or a related scientific field.
2–5 years of experience in a GMP-regulated Quality Control or analytical laboratory.
Strong, hands-on proficiency in:
- iPSC-derived cell culture and characterization
- Mammalian cell culture techniques
- Flow Cytometry
- ddPCR
Experience with qPCR and other molecular methods.
Solid understanding of GMP principles, documentation practices, and regulatory compliance.
Demonstrated analytical and problem-solving skills, with experience troubleshooting assays and instruments.
Excellent organizational, communication, and teamwork skills.
Pay: From $75,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
Salary : $75,000