Quality Control Scientist

Trailhead Biosystems is seeking a Quality Scientist with deep expertise in iPSC biology and quality control to serve as the company’s first dedicated quality hire. This role blends hands-on laboratory work with quality oversight, focusing on the development of QC parameters, release specifications, and Certificates of Analysis (CoAs) for iPSC and iPSC-derived cell products.

The Quality Scientist will be responsible for defining and implementing analytical methods and QC frameworks that ensure reproducibility, traceability, and scientific rigor across Trailhead’s RUO product portfolio. The ideal candidate will have experience with iPSC derivation and differentiation and the ability to translate that knowledge into robust QC systems.

Responsibilities

Quality Control & Product Release

• Define critical quality attributes (CQAs), QC parameters, and release specifications for iPSC and iPSC-derived products.
• Establish and maintain Certificates of Analysis (CoAs) for differentiated cell types.
• Perform QC testing for in-process controls, final products, stability, and comparability studies.

Analytical Method Development & Testing

• Develop, optimize, and qualify analytical methods and assays (flow cytometry, ICC/IF, qPCR, ELISA, viability/potency assays, functional assays).
• Verify and troubleshoot analytical methods to ensure robustness, reproducibility, and transferability.
• Establish standardized QC panels for pluripotency, genomic stability, and differentiation identity/purity.
• Evaluate and validate new assays to support characterization of novel iPSC-derived products.

iPSC Workflow Oversight

• Provide quality oversight for iPSC derivation, expansion, banking, and differentiation workflows.
• Partner with scientific teams to ensure traceability and reproducibility across differentiation runs.
• Monitor and define process parameters critical to downstream product quality.

Quality System Development

• Contribute to building fit-for-purpose quality systems, including document control, training, deviations/CAPA, change control, and equipment qualification.
• Author and maintain SOPs, QC protocols, test methods, and quality policies.
• Conduct internal audits and gap assessments; support preparation for ISO certification.

Data Management & Continuous Improvement

• Implement practices for data integrity, trending, and statistical analysis of QC results.
• Identify opportunities for process improvement and assay optimization.
• Track and report quality metrics to guide decision-making.

Collaboration & Training

• Work closely with R&D, MSAT, and manufacturing to integrate QC into product development and production workflows.
• Train staff on QC assays, data documentation, and quality principles.
• Provide input on product characterization and release strategies.

Qualifications

• Master’s or advanced degree in Biology, Biotechnology, Biomedical Engineering, or related field.
• 3–5 years of experience in Quality Control/Quality Assurance, with at least 2 years in cell-based products (iPSCs strongly preferred).
• Proven experience developing and qualifying analytical methods and assays for cell characterization and release.
• Strong knowledge of iPSC biology, including derivation, expansion, differentiation, and banking.
• Experience defining product release specifications, CQAs, and CoAs for cell-based products.
• Familiarity with ISO 9001/13485 quality standards; experience in RUO or preclinical environments preferred.
• Strong problem-solving, analytical, and organizational skills.
• Ability to work independently and collaboratively in a dynamic, hands-on environment.

Location

On-Site, Beachwood, Ohio