Senior Process Development Associate - Fremont, CA | Biospace
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Senior Process Development Associate

Asterias Biotherapeutics

Fremont, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Development, Process, Process Development,

Job Description

Position Description

The Senior Process Development Associate position will work with all or select technology and process development efforts within the company.  Development will facilitate testing and implementation of future production processes and technologies and is responsible for process conversions and technology integration to allow scale appropriate process transfer to either in-house or outsourced production. This position will liaise with Research, Manufacturing, Engineering, Quality, and Analytical Technologies to foster effective communication, technology transfer and achievement of corporate goals.  The position will work alongside PD and Research staff to support process improvement targets and optimize process implementation. This position will participate in daily operations of development laboratories.  This individual will assist in corporate development presentations and publications.  
Summary of essential job functions

•   Execute experiments directed towards scale-up process development and optimization using undifferentiated human embryonic stem cells and their derivatives: including but not limited to regular passaging of cells, cell banking, thawing and processing samples.
•   Optimize logistics and processing for formulation, fill, & finish operations for final delivery of cell therapy product to patients.
•   Solve technical issues and evaluate and implement new technology/instrumentation based on scientific literature and industry trends as well as requirements for GMP production.
•   Generate technical documents and support technology transfer efforts (protocols, technical reports, summaries, process investigations, SOPs and batch records).
•   Generate, manage, evaluate, and maintain complete and accurate laboratory documentation and critical data in electronic files in a highly organized manner.
•   Collaborate with cross-functional teams i.e., Research, Quality, Engineering, Manufacturing and Analytical Technologies.
•   Support process sampling plan to monitor process development activities and optimization through adequate sample archives.
•   Present and discuss experimental findings in lab and departmental meetings.
•   Train new hires on the process of culturing uhESC and differentiation into various products.


Minimum Requirements:

•   BS (3-5 years) or MS (2+ years) in Chemical Engineering/Biological Engineering, Biology, Biochemistry, or related field with relevant corporate experience at a pharmaceutical or biotechnology company.
•   Experience in cell-based therapy culture and development.
•   Prior experience in bioreactor operation or development a plus.
•   A proven record of innovation, excellent laboratory, data analysis, and critical thinking skills required.
•   Strong communication abilities (verbal, written, interpersonal).
•   Excellent time management skills (schedules, timelines, task prioritization) and the ability to adapt to changing priorities.
•   Excellent multi-tasking and problem-solving skills; solution-oriented; self-motivated.
•   Flexible in regards to weekends and holiday work schedule.
•   Thrive and succeed in a team-oriented entrepreneurial environment.

Abilities required

Computer literacy with standard corporate (MS) required
Familiarity with JMP® DOE and statistical software desired