Product & Process Development Scientist
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POST DATE 9/9/2016
END DATE 10/10/2016
JOB DESCRIPTIONThe Product Development Scientist position will focus on downstream process development as well as working with device engineering personnel within and external to the company.
As a member of Process Development, this position will facilitate testing and implementation of future production processes as well as process conversions and technology integration to allow a scaled process transfer for either in-house or outsourced production.
Product Development engineering responsibilities include interfacing with Process Development team members, Quality teams, as well as supervision of the internal device engineer and external suppliers to define, develop, test, and deliver process and product engineering solutions around cell therapy drug product delivery; cell isolation / depletion; filtration; closed system scale-up implementation, formulation selection, primary/secondary packaging, and automated vial filling technologies.
The position will work alongside Process Development, Manufacturing, Quality, and Clinical staff to direct process and product improvement targets and optimize process implementation. This individual will also participate in corporate development presentations and publications as well as provide technical guidance and input for timely patent filings and prosecutions. This position will assist in defining resource requirements, develop budgets, manage facility needs and create timelines.
Summary of essential job functions
Maintain and expand expertise in cell therapy and immunotherapy technologies, production, formulation, and delivery
Perform/direct scale up and certification of cell isolation / depletion technologies
Oversee new therapeutic candidate administration device design, sourcing, release and training
Perform/direct improvement of existing processes through closed system and scale-up development
Lead/Assist in formulation development, cryopreservation optimizations and efforts
Direct/Oversee product engineer s efforts including product device design, creation, and implementation
Participate in current drug product delivery and administration optimization efforts
Integrate QBD guidelines into new processes
Generate publications on process improvements and technology integration
Lead and coordinate staff career development efforts
Assist/lead product and engineering device related FMEA, as necessary
Participate in Asterias multidisciplinary project teams to help oversee development activities
Coordinate and write technical reports on key development findings
Support regulatory experts to prepare, file and maintain appropriate regulatory body documents
Assist project management to determine development activities, timelines and resource needs to meet corporate goals
As necessary, assist corporate development to support contracts and other legal documents to execute workplans and projects
As necessary, work with Asterias legal professionals to file and prosecute Asterias intellectual property