Are you a Process Engineer with a passion to learn and develop skills in cell therapy manufacturing? Join us at Aspen Neuroscience where we are creating personalized cell therapies for the treatment of Parkinson's disease. Reporting to the Head of Process Development, this position supports the PD team to develop and implement new process steps and/or to optimize current processes. The candidate will also support the tech transfer of manufacturing process to internal MFG and/or to CDMOs.
Duties & Responsibilities
- Work cross-functionally with a team of scientists, bioinformatic specialists and research/development associates
- Optimize fill/finish of drug product (DP)
- Evaluate container closure and drug delivery systems that is suitable for Aspen DS/DP and intermediates.
- Support the execution of stability studies of DS and DP to support the IND filling
- Evaluate current manufacturing operation units and perform optimization studies
- Evaluate the feasibility of using closed system in some steps of manufacturing process
- Execute drug delivery system compatibility and consistent cell dose delivery bench study
- Support manufacturing process qualification and aseptic process simulation runs
- Prepare SOP, qualification protocols, reports and other documentation
- Serve as a subject matter expert on the manufacturing of cell therapy products
- Execution of cGMP operations as required
- May train MFG associates and/or lead cGMP manufacturing activities in the cleanroom
- May perform other duties and responsibilities as needed
Education & Experience
- Bachelor’s Degree in Chemical Engineering, Biochemical/Biomedical Engineering or a related discipline. Advanced degree is a plus
- 5+ years of hands-on experience in the biotechnology, biologics or pharmaceutical industry (GMP environment is a plus)
- Must have a solid understanding of and experience with: Aseptic tissue culture of mammalian cells (pluripotent stem cells is a plus); Scale-out cell manufacturing process; Closed system for cell culture (cryopreservation is a plus); Container closure and Drug delivery systems (e.g. injection cannula).
- Working knowledge of cGMP guidelines, Design of Experiments (DoE) and/or Design Controls, Execution of Qualification/Validation protocols, Statistical analysis 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, gym membership, and other wellness perks.