Process Development Manufacturing level 3, Palo Alto, CA
***Must have experience with induced pluripotent stem cells and assay development***
This position will join a stellar team of PDM 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.
- 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.
- 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 cGMP clean room experience
- 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
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.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. 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.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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