Product Development (PD)
Full Time - Fremont, CA 94555
The Product & Process 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
- Ph.D.in Life Sciences, Chemical, Mechanical or Bio-Engineering
- 3 or more years corporate experience within pharmaceutical or biotechnology
- Experience in process development of cell-based therapy or immunotherapy cell culture required
- Experience in hESC culture, dendritic cell, and CMC filings desired
- Strong oral and verbal communications skills with a collegial personality
- A proven record of innovation
- Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business
- Thrive and succeed in a team-oriented entrepreneurial environment
Computer literacy with standard corporate (MS) software required
Familiarity with JMP® DOE and statistical software desired
Up to 25% travel required, some international
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.