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 hands-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.

 

DUTIES AND RESPONSIBILITIES:

  • 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.

 

EDUCATION AND EXPERIENCE:

  • 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.

 

JOB SPECIFICATIONS:

  • 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 cleanrooms.
  • Flexible Schedule: Must be willing to work flexible hours including some weekends.

 

EEO and Employment Eligibility:

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 inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

 

Total Rewards and Culture:

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

 

The anticipated salary range for candidates who will work in San Diego $121,500 to $148,500 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.  Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.