Process Engineer
- Employer
- Aspen Neuroscience
- Location
- San Diego, California
- Start date
- May 15, 2022
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
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)
Job Specifications
- 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.
Company
Headquartered in San Diego, Aspen Neuroscience, Inc. is a development stage, private biotechnology company focused on personalized cell therapies. We are developing autologous (the patient’s own) induced-pluripotent stem cells (iPSCs) to address diseases with high unmet medical need, beginning with autologous neuron replacement for both sporadic and genetic forms of Parkinson’s disease (PD).
As a leading iPSC platform company, we combine stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. We have developed a best-in-class platform to create and characterize pluripotent-derived cell medicines, including in-house bioinformatics, manufacturing and QC.
Located in scenic Torrey Pines, Aspen features a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and collaboration. The leadership team is committed to attracting and retaining the highest caliber talent to develop meaningful therapies for patients in need.
- Website
- https://aspenneuroscience.com/
- Phone
- (858) 263-1222
- Location
-
10835 Road to the Cure, Ste. 100
San Diego
California
92121
United States
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