Aspen Neuroscience is looking for a Process Development Associate to serve as a key member in the Process Development team. This role will help build a well-defined and robust process manufacturing dopaminergic neurons (DANs) progenitor cells from patient’s own fibroblasts utilizing induced pluripotent stem cell technology.
Duties and Responsibilities
- Under minimum supervision, perform engineering and scientific studies to identify critical process parameters, finding acceptable ranges to build a robust and defined process. Collect and analyze data and generate technical reports.
- Perform studies to qualify GMP/Clinical grade raw materials to replace materials currently being used in the process.
- Evaluate commercially available technologies that may be implemented to automate critical unit operations.
- Perform cell culture using aseptic techniques to generate cells to enable evaluation of device or technologies.
- Help tech transfer MFG process to GMP cleanroom to support the manufacturing of clinical trial materials.
- Help support maintaining of material inventory and laboratory supplies for PD.
- Serve as a backup operator to clinical manufacturing of cell therapy product under GMP in a controlled cleanroom environment when required.
- Mentor junior team members
Education and Experience
- BS degree with 3 years of experience in a relevant industry, OR a MS degree Bioengineering/Biomedical Engineering or Cellular or Molecular biology with some experience working in academia laboratories or within a relevant industry
- Knowledge and experience with Aseptic Techniques is required.
- Working knowledge of iPSC culture is preferred
- Working knowledge cryopreservation of mammalian cells is highly desired
- Proficiency with commercially available software for statistical analysis is preferred
- Excellent written and verbal communication skills
- Ability to multitask
- Strong organizational and documentation skills
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, gym membership, and other wellness perks.
For immediate consideration, apply here: https://app.trinethire.com/companies/21059-aspen-neuroscience/jobs/62232-process-development-associate