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Manufacturing Specialist (Palo Alto, CA)

Kelly Services

Palo Alto, CA
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Job Details

Job Title Manufacturing Specialist (Palo Alto, CA)

Jobid US15TPDP_BH1394014

Location: Palo Alto, CA, 94301, USA

Description **Manufacturing Specialist (Palo Alto, CA)**

Direct Hire! Full-time Position.


The Laboratory for Cell & Gene Medicine is seeking a Manufacturing Specialist. The LCGM is a ~10k ft2 multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.
This position includes performing dermal graft manufacturing for patients with epidermolysis bulosa . This role works both independently and collaboratively across the 5 functional teams: Process Development & Manufacturing, Regulatory Affairs, Quality Systems, Operations and Finance & Administration.

This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.

LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Our Company’s mission. We invite you to join our team!


+ Perform complex (lab and/or field) experiments for a major portion of the research project. Maintain detailed records of experiments and outcomes.
+ Interpret and analyze results, often where few guidelines exist. Based on prior results, contribute to development of new research protocols and procedures or adaptation of existing protocols.
+ Make recommendations on plan design and/or research direction to principal investigator.
+ Work with health and safety department to ensure lab complies with regulations and all required trainings.
+ Participate in multidisciplinary teams across different faculties or schools.
+ Oversee supply and equipment budget under supervision of principal investigator or business manager.
+ Perform ongoing literature review to remain current with new procedures and related research; present findings for lab work group.
+ Contribute substantively to the preparation of papers for publication, especially in the results section. May contribute to publication of findings and present ongoing work and findings to colleagues at academic conferences.
+ Supervise (either formally or informally) staff or students as needed, including oversight and instruction on techniques, as well as consultation on project work. Serve as technical resource for other research staff.
+ Perform general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed. May assist with purchasing laboratory equipment.
+ Other duties may also be assigned

+ Bachelor's degree in related scientific field and three years of related experience, or Master's degree.

+ Bachelor's Degree in Chemistry, Microbiology, etc.
+ Aseptic technique experience is preferred
+ cGMP experience is preferred
+ Knowledge and following SOPs and batch records preferred KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

+ Comprehensive understanding of scientific principles.
+ General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications.
+ Strong analytical skills and excellent judgment.
+ Ability to work under deadlines with general guidance is essential.
+ Excellent organizational skills and demonstrated ability to accurately complete detailed work.

+ Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds.
+ Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts.
+ Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls.
+ Must have correctible vision to perform duties of the job.
+ Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours.
+ Ability to lift heavy objects weighing up to 50 pounds.
+ Ability to work in a dusty, dirty, and odorous environment.
+ Position may require repetitive motion.
+ 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.

+ Work in ISO-7 (209E Class 10,000) clean room for multiple hours at a stretch depending on needs and demands of project and product being manufactured

+ May require working in close proximity to blood borne pathogens.
+ May require work in an environment where animals are used for teaching and research.
+ Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
+ Employee 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 require extended or unusual work hours based on research requirements and business needs.

+ Will work with viruses: lentiviruses, adeno-associated viruses, retroviruses
+ May work with human embryonic stem cells (hESCs)
+ Complete Training for working in manufacturing clean rooms
+ May work long hours during manufacturing and product release (which may include weekend work for manufacturing and product release); required to stay until product is released
+ Complete all required training for the facility and for each project related to safety, quality, regulatory and operations
**Why Kelly?**

As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Weekly pay and service bonus plans
+ Group- rate insurance options available immediately upon hire*
**_Apply Today!_**

**Why Kelly** **®** **?**

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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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