1+ months

Manufacturing Process Development Assistant Director

Kelly Services
Palo Alto, CA 94301
**Manufacturing Process Development Assistant Director- Palo Alto, CA**

**Direct Hire**

****Experience with project management, direct reports, GMP manufacturing, cell therapy, and process development**

This position will manage a stellar team of PDM Scientists as well as 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. Manufacturing PD Manager will have experience with project management and manager experience. 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.

**Duties include:**

+ 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. - Other duties may also be assigned

**_For immediate consideration, apply today!_**

**Why Kelly** **** **?**

Kelly Science 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. at


Posted: 2020-01-27 Expires: 2020-04-16

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Manufacturing Process Development Assistant Director

Kelly Services
Palo Alto, CA 94301

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