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1+ months

Cell Therapy Process Development & Manufacturing Associate II (Stanford, CA)

Kelly Services
Palo Alto, CA 94301
Cell Therapy Process Development & Manufacturing Associate II



Stanford, CA



Direct Hire



Our client is seeking a Clinical Process Development Manufacturing Professional 2 to independently conduct major portions of complex process development and clinical materials biomanufacturing consistent with principles of current Good Manufacturing Practice cGMP and aligned with the clinical trial investigational phase for treating patients with incurable diseases.



This recruitment is for up to four 4 full time positions.



Duties include:




+ Lead human clinical materials biomanufacturing campaigns primarily as an operator.

+ Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.

+ Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business administration.

+ Train on biomanufacturing procedures, Batch Records or provide direction during process development activities.

+ Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.

+ Plan and perform upstream and downstream components of assigned cGMP projects.

+ Identify strategies for innovation in production systems and manufacturing processes.

+ Identify operating excursions and facility deficiencies during manufacturing.

+ Determine deviations and provide recommendations for Corrective and Preventive Action CAPA for Batch Records.

+ Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per/patient costs for project materials and supplies and hours dedicated to complete all manufacturing steps.

+ Determine need for, devise and revise Standard Operating Procedures and Batch Records.

+ Oversee cGMP grade raw materials acquisition for biomanufacturing.

+ Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.

+ Other duties may also be assigned



DESIRED QUALIFICATIONS:




+ Bachelor s degree in chemistry, microbiology, etc. Aseptic technique experience is preferred cGMP experience is preferred

+ Knowledge and following SOPs and batch records preferred



EDUCATION EXPERIENCE REQUIRED :




+ Bachelor s degree in related scientific field and two years of related experience, or Master s degree, or an equivalent combination of education and relevant work experience.



KNOWLEDGE, SKILLS AND ABILITIES REQUIRED :




+ Strong biological scientific background Working experience with aseptic cell culture cGMP clean room experience

+ Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications

+ Ability to work under deadlines with minimal supervision

+ Ability to maintain relationships and communicate effectively

+ Excellent organizational skills and demonstrated ability to complete detailed work.



CERTIFICATIONS LICENSES: None



PHYSICAL REQUIREMENTS :




+ Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.

+ Consistent with its obligations under the law, they will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.



WORKING CONDITIONS:




+ May require working in close proximity to blood borne pathogens.

+ Ability to work under deadlines and meet/ exceed unpredictable manufacturing schedules.






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect with us today.




**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 https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-10-14 Expires: 2019-11-25

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Cell Therapy Process Development & Manufacturing Associate II (Stanford, CA)

Kelly Services
Palo Alto, CA 94301

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