Process Engineer, Automation

SUMMARY: 
Aspen is looking for a Process Engineer with experience in automation to join its team. This role will focus on developing closed processes to manufacture the Company's cell therapy using automated cell culture systems, integrate with other unit operations, and transfer a qualified process to GMP Manufacturing. The ideal candidate is eager to learn and develop new, scalable processes for autologous iPSC cell therapy.

DUTIES AND RESPONSIBILITIES: 

• Work collaboratively to support the execution of a process development program to:
  • Develop and optimize culture protocols and hardware/software for closure and automation of derivation and expansion of iPSC and of their neuronal differentiation
  • Scale-out this process to achieve manufacturing capacity and COGS (cost of goods) benchmarks and change the form factor from open cell culture vessels to enable process closure and automation
  • Integrate the automated cell culture system(s) to other unit operations including cell-washing, volume handling/reduction and cell cryopreservation
  • Transfer these processes to Manufacturing Operations for cGMP manufacture of the company's cell therapy products 
• Optimize fill/finish of drug product (DP)
• Evaluate current manufacturing unit operation and perform optimization studies
• Prepare SOP, qualification protocols, reports, and other documentation
• Serve as a subject matter expert on the manufacturing of cell therapy products

EDUCATION AND EXPERIENCE: 

• Bachelor's degree in chemical engineering, biochemical/biomedical engineering, or a related engineering discipline. Advanced degree is highly preferred.
• Minimum 5 years (or equivalent education/experience with advanced degree) of hands-on experience in the biotechnology, biologics, or pharmaceutical industry (GMP environment preferred)

JOB SPECIFICATIONS: 

• Must have a solid understanding of and experience with: 
  • Aseptic tissue culture of mammalian cells (pluripotent stem cells is a plus) 
  • Scale-up/Scale-out and automation of cell manufacturing process
  • Closed systems for cell culture (fill/finish and cryopreservation is a plus)
  • In-Process-Controls to analyze data and define/optimize cell culture instrumentation parameters (machine vision and analysis software enabled manufacturing instrument autonomous decision-making/operation is a plus)  
• Strong working knowledge of cGMP guidelines, Design of Experiments (DoE) and/or Design Controls, Execution of Qualification/Validation protocols, Statistical analysis, and process modeling software.
• Sterile tissue culture experience, particularly with iPSC or neural progenitor cell differentiation and maintenance would be preferred.
• Strong work ethic and a proven ability to work effectively in a multi-disciplinary team environment. 
• Detail oriented with an ability to communicate clearly, proactively, and effectively.
• Knowledge of qualification/validation protocols.
• Experience with statistical analysis (e.g. JMP) and modeling software
• 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 salary range for candidates who will work in San Diego is 100K-160K annually. The final compensation 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.