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30 days old

Clinical Process Development & Manufacturing Professional

Kelly Services
Palo Alto, CA 94301
**Clinical Process Development & Manufacturing Associate II (Palo Alto, CA)**



**Job Description:**

Kelly Science is seeking a Clinical Process Development & Manufacturing Associate 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.



**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



**Job Requirements:**




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

+ 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.



**Physical Demands:**




+ 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, the University 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.

+ Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.

+ Position requires working in a cGMP clean room environment.

+ Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.

+ Position may work with human embryonic stem cells (hESCs).

+ Must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.

+ May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA Allergens/Biohazards/ Chemicals, and confined spaces, working at heights.

+ May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.







**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

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Posted: 2019-10-21 Expires: 2019-11-21

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Clinical Process Development & Manufacturing Professional

Kelly Services
Palo Alto, CA 94301

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