Kelly Services Process Development and Manufacturing Scientist III in Palo Alto, California
Kelly Science and Clinical is the world’s most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.
This position will join a stellar team of Process Development and Manufacturing Scientist Scientists and will provide highly specialized technical research, support and expert consultation including identifying, innovating and designing solutions for unique process development and manufacturing activities related to clinical materials manufacturing. Work is to be consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
Lead development activities for new processes and procedures for first-in human clinical materials development including design of process scale-up and scale-out, closed systems and engineering runs to meet clinical materials requirements.
Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business & administration; maintain regular reporting to functional manager.
Develop methods for, perform and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2), cGMP-level work conditions and adherence to corresponding requirements.
Develop standard operating procedures (SOPs), Batch Records and product specifications. Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity. Present data to functional manager and collaborative groups to support product and process specification.
Author or co-author of manuscripts for publication in peer-reviewed journals. Remain current on literature and standard industry practices by attending scientific meetings/conferences.
Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (IND) Regulatory Filing.
May manage two or more staff in day-to-day operations for functional area(s) of responsibility. Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees. Ensure work completion within schedules and constraints.
May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
May serve as safety officer; responsible for ensuring implementation of EH&S, fire and city regulations for laboratory safety.
A bachelor's degree in related scientific field and four years of related experience, or master’s degree and two years of related experience or an equivalent combination of education and relevant work experience.
Excellent understanding of scientific principles
Working experience with aseptic cell culture
Excellent computer skills and ability to learn quickly and master computer programs, databases and scientific applications
Ability to work independently, maintain relationships and provide ongoing reporting to functional management
Excellent organizational skills and demonstrated ability to complete detailed work.
cGMP cleanroom experience.
Gene editing experience e.g. CRISPR/Cas9
Process development experience
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)