Aspen is seeking a Process Development Associate II to join a highly collaborative team that is building a well-defined and robust process to manufacture dopaminergic neurons (DANs) progenitor cells. The ideal candidate has a strong attention to detail, proficiency in aseptic technique, and a passion for developing and performing scientific studies supporting the scale of manufacturing.
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.
- Facilitate tech transfer of manufacturing process to GMP cleanroom to support the manufacturing of clinical trial materials.
- Support maintaining of material inventory and laboratory supplies for Process Development.
- Serve as a backup operator to clinical manufacturing of cell therapy product under GMP in a controlled cleanroom environment when required.
- Mentor and train junior team members
EDUCATION AND EXPERIENCE:
- BS degree in Bioengineering/Biomedical Engineering or Cellular or Molecular biology with 3 years of experience in a relevant industry or a MS degree with some experience working in academia laboratories or within a relevant industry.
JOB SPECIFICATIONS:
- Knowledge and experience with aseptic techniques is required.
- Working knowledge of iPSC culture is preferred
- Working knowledge of 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, onsite gym, and other wellness perks.
The anticipated pay range for candidates who will work in San Diego is $79K to $89K. 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.