QC Scientist II

Aspen is looking for a detail-oriented Quality Control (QC) Scientist II to join its team. This predominantly lab-based role requires someone who is eager to contribute to analytical method development, optimization, qualification and validation for QC testing of cell therapy products. The ideal candidate has extensive h ands-on laboratory experience in flow cytometry, real-time PCR, cell culture and molecular biology. Experience in working with stem cells is preferred.

This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

• Serve as a key contributor for analytical method design, development/optimization and troubleshooting, may lead training of junior group members.
• Serve as a key contributor for qualification and validation of analytical methods and bioinformatics assay transfer.
• Conduct QC tests in compliance with quality standards and Current Good Manufacturing Practice (cGMP) regulations.
• Author and revise development report, standard Operating Procedure (SOPs) and technical documentation.
• Lead investigations of deviation or out-of-specification results in QC laboratory.
• Apply cGMP requirements applicable to QC laboratory.
• Provide scientific/technical training, advice, and coaching to junior team members.

• M.S. with a minimum of 4 years of relevant experience, or Ph.D. with minimum of 2 years of relevant experience in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry, or related field; or equivalent relevant education and experience.
• Extensive hands‑on laboratory experience in flow cytometry, real‑time PCR, cell culture and molecular biology are required.
• Experience with stem cells, assay automation, bioinformatics analysis, and GMP operations is preferred.
• Experience working with real‑time PCR and flow cytometry assay automation is preferred.
• Experience working with bioinformatics analysis is preferred.
• Experience working with analytical method development in GMP setting is preferred.
• Experience working with electronic GMP operation system is preferred.

• Analytical
  
  Skills:
  
  Advanced quantitative skills, including statistical analysis and critical evaluation of experimental data; ability to interpret results, draw conclusions, and make recommendations.
• Cell Culture Techniques: Excellent proficiency in aseptic cell culture techniques.
• Professional Scientific Expertise: Strong knowledge of scientific concepts and analytical method development in GMP.
• Technical Writing: Skilled in developing and finalizing SOPs, protocols, and reports that meet regulatory agency standards for clarity and compliance.
• Organization and Project Management: Highly organized with project coordination abilities and developing skills to lead projects.
• Communication
  
  Skills:
  
  Strong verbal and written communication skills to effectively convey scientific ideas, results, and strategic recommendations across departments.
• Collaboration & Project Management: Ability to coordinate workflows across teams, facilitate study planning and execution, and contribute to cross‑functional initiatives; developing skills in project leadership and technical training for colleagues.
• Detail Oriented: Excellent organizing and documentation skills with a meticulous eye for detail.
• Problem‑Solving
  
  Skills:
  
  Able to effectively address moderately complex issues through thorough analysis and use judgment in selecting the right course of action.
• Adaptable: Effective in a fast‑paced, startup company environment, and able to adjust workload based on changing priorities.
• Computer Software: Experience with statistical analysis software, electronic GMP operation system. Effective in Microsoft office suite.
• Gowning Certification: Ability to independently gown for clean rooms.
• Flexible
  
  Schedule:
  
  Must be willing to work flexible hours including some weekends.

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an…