Build your QC career in cell therapy at Aspen Neuroscience. This newly opened role for a Quality Control (QC) Scientist II reports to the Director of QC. This position will contribute to analytical method development/optimization/qualification as well as the testing of drug product and intermediates to support induced pluripotent stem cells-derived cell therapy products for the treatment of neurological conditions in clinical trials.
DUTIES AND RESPONSIBILITIES:
- Work on stage appropriate analytical method design, development/optimization and troubleshooting, may lead training of junior group members.
- Work on analytical method qualification and validation studies.
- Conduct QC tests following test protocols and procedures in compliance with quality standards and Current Good Manufacturing Practice (cGMP) regulations.
- Deliver cGMP compliant testing data and reports.
- Authoring and revising development report, standard Operating Procedure (SOPs) and technical reports.
- Participate in investigation of deviation or out-of-specification results in QC laboratory.
- Apply cGMP requirements applicable to QC laboratory.
- Work closely within a cross-functional team of research and development, bioinformatic specialists, process development and GMP manufacturing.
- May perform other duties and responsibilities as assigned.
EDUCATION AND EXPERIENCE:
- M.S. with 3+ years of relevant experience, or Ph.D. with 1+ years of relevant experience in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry.
- Experience working with analytical method development in GMP setting is preferred.
- Hands-on laboratory experience in flow cytometry, real-time PCR, cell culture and molecular biology is required.
- Experience in working with stem cells is preferred.
JOB SPECIFICATIONS:
- Knowledge of cGMP guidelines and compliance in QC lab (environmental monitoring, audits, CAPA, OOS and deviation events).
- Ability to author SOPs, protocols, and reports.
- Possess scientific creativity, technical proficiency, and knowledge of scientific concepts.
- Ability to use Design of Experiments in GMP or other for experimental design & data analysis.
- Knowledge of statistical methods applicable to the analysis of experimental data.
- Must be very detail-oriented and organized.
- Ability to show a high level of initiative in a fast-paced environment.
- Ability to work in teams as well as independently.
- Strong verbal and written communication skills to effectively communicate ideas and strategies.
- Strong critical thinking, problem-solving, quantitative skills, and analytical skills required.
- Highly organized and ability to coordinate projects.
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.
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.