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19 days old

Process Development and Manufacturing III, Palo Alto, CA

Kelly Services
Palo Alto, CA 94301
**Process Development and Manufacturing III, Palo Alto, CA**



**Direct Hire**



**Process development and manufacturing activities related to clinical materials manufacturing and clinical trial investigational products under cGMP.**



**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 EHS, fire and city regulations for laboratory safety.

+ Other duties may also be assigned



**Desired Qualifications:**




+ cGMP experience.

+ Gene editing experience e.g. CRISPR/Cas9

+ Process development experience



**Education Required/Skills:**




+ Bachelor's degree in related scientific field and four years of related experience.

+ Master's degree and two years of related experience or an equivalent combination of education and relevant work experience.



**Knowledge/Skills Required:**




+ Excellent understanding of scientific principles.

+ Working experience with aseptic cell culture cGMP clean room 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 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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-11 Expires: 2020-12-12

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Process Development and Manufacturing III, Palo Alto, CA

Kelly Services
Palo Alto, CA 94301

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