Process Development Associate
The Process Development Associate position will work on technology and process development efforts for our human stem cell-derived therapies within Asterias. The Process Development team facilitates testing and implementation of future production processes and technologies and is responsible for process conversions and technology integration to allow scale appropriate process transfer for either in-house or out-sourced production. This position will support collaborations with Research, Production, Bioengineering, 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 improvements targets and optimize process implementation. This position will participate in the daily operations of development laboratories.
Summary of Essential Job Functions
· Assists in experiments directed towards process development and optimization using undifferentiated human embryonic stem cells: including but not limited to preparation of cell culture raw materials, monitoring, sampling and documenting of cell culture performance, regular passaging of cells, thawing and freezing cell lines, cell banking and processing samples.
· Generate, manage, evaluate, and maintain complete and accurate laboratory documentation and critical data in electronic files in a highly organized manner.
· Operates and troubleshoots cell culture equipment.
· Maintains lab operations.
· Draft and review technical documents (protocols, technical reports, summaries, process investigations, SOPs and batch records).
· Collaborate with cross-functional teams i.e., Research, Quality, Production, and Analytical Technologies.
· Perform process sampling to monitor process development activities and optimization through adequate sample archives.
· BS in Biology, Biochemistry or related field, with 2 years’ experience in industry or academic lab required.
· Experience in aseptic mammalian cell culture handling experience required.
· Experience in cell-based therapy culture and/or development desired.
· A proven record of strong laboratory and critical thinking skills required.
· Excellent communication abilities (verbal, written, interpersonal).
· Excellent time management and organizational skills (schedules, timelines, task prioritization), with 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.
· Occasional weekend work expected.
· Thrive and succeed in a team-oriented entrepreneurial environment.
Computer literacy with standard corporate (MS) required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed