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20 days old

Associate Scientist I or II, Cell Culture

Kelly Services
Fremont, CA 94536
**Associate Scientist I or II, Cell Culture**


**Fremont, CA**


**Direct-Hire**


**Job Description:**


The Associate Scientist I or II, Cell Culture is responsible for providing hands-on execution of complex experiments in a team setting. This is a great opportunity to join a growing CDMO in Fremont, CA. This is a direct-hire opportunity with a schedule of Mon-Fri during normal working hours with some OT/weekend flexibility required.


**Essential Duties and Responsibilities:**


+ Executes, with oversight of qualified staff, complex unit operations including but not limited to media prep; cell culture thaw, expansion, and end of production banking; operation of single-use bioreactors, process monitoring and harvest operations.

+ Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.

+ Maintains own training within compliance.

+ Support in equipment troubleshooting, pilot scale material generation, non-GMP toxic material generation and GMP upstream manufacturing activities.

+ Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.

+ Documents work according to cGMP and cGDP.

+ Adheres to established regulations and follows cGMP established by site.

+ Maintain cleanroom standards, practices, and housekeeping according to SOPs.

+ Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify supervisors and leads of issues and discrepancies immediately.

+ Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.

+ Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.

+ Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling


**Qualifications:**


+ BS or MS in Engineering, Life Sciences, or related discipline with 1 to 5 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.

+ In-depth understanding of molecular biology and/or chemical engineering and industry-standard cell culture processes (aseptic technique, fed-batch and perfusion operations, harvest, etc) and equipment (BSCs, bioreactors and disposables)

+ Hands-on experience in running, developing, and validating processes

+ Experience in process development, process characterization and/or tech. transfer processes.

+ Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing

+ Experience with process monitoring software and equipment software (UNICORN, Pi Historian)

+ Creative thinker that can identify better and more efficient methods to address issues and gaps

+ Demonstrate ability to work independently and on cross-functional teams.

+ Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-08-27 Expires: 2021-09-27

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Associate Scientist I or II, Cell Culture

Kelly Services
Fremont, CA 94536

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