Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. We have an exciting temporary opportunity in Sunnyvale, CA for a Manufacturing Associate.
As a member of our client’s Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes. Furthermore, you will be responsible for completing successful qualifications and ongoing support procedures for bioprocessing operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records and other GMP documentation.
• Complete successful gowning qualification and material flow procedures for bioprocessing operations.
• Process / Manufacturing cell therapy products for clients, including developmental (no patient infusion) as well as clinical activities (patient infusion)
• Initiate Change Controls, Investigations and Deviations as required.
• Assist in the developing, writing, and reviewing of Standard Operating Procedures (SOP), Material Specifications (MS), Standard Manufacturing Procedures (SMP), Master Production Records (MPR) and other GMP documentation.
• Troubleshoot processing issues, including investigation for root cause and implementation of corrective and preventive action (CAPA) plans.
• Experience in clinical processing in the cell therapy industry and/or cell culture operations in the biotechnology industry. Experience with cell culture and aseptic/closed system processing, excellent written and oral communication skills in English, knowledge of current GMP and GTP regulations, and MT (ASCT) preferred.
• This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures.
• Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers.
• While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment.
• The noise level in the work environment is usually moderate.
• Bachelor’s degree in biological science or related discipline
• Minimum of 1-3 years of experience in clinical processing and/or cell culture operations preferably in a GMP environment; or equivalent combination of education and experience Experience with cell culture and aseptic/closed system processing.
• Must possess a strong working knowledge of GMP and GTP regulations.
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 relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
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 career—connect with us today.
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.