JobWatch

1+ months

SeniorCell Manufacturing Associate

Kelly Services
Arcadia, CA 91007
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with meaningful work with industry leading employers. Today we are excited to be hiring a **_Senior Cell Manufacturing Associate_** for an exciting therapeutics start-up in Arcadia, CA! The **_Sr._** **_M_** **_anufacturing Associate_** will be responsible for the hands-on manufacturing of clinical cell products in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. You will set up, operate, and maintain various cell therapy production equipment as assigned and thoroughly and accurately document all activities to ensure compliance with regulatory guidelines.


**Responsibilities:**


+ Performs the hands-on manufacture of cell therapy products, using state-of-theart cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, M1 Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and CellDrop).

+ Follows and executes batch records and standard operation procedures. 2

+ Performs aseptic and closed manipulations within Biosafety Cabinet and Grade B, C and D Cleanrooms.

+ Performs manufacturing process steps in accordance with cGMP, procedures and relevant regulations.

+ Performs delegated work assignments in a timely and complete manner.

+ Supports Process Development and Manufacturing Sciences, as needed.

+ Authors and maintains controlled documents including but not limited to SOPs, forms, and batch records.

+ Assists with deviation investigations and implementing CAPAs.

+ Assists with qualification and validation activities including equipment qualification, gown qualification, aseptic process validation and process qualification/validation.

+ Maintains manufacturing facility in a 5S and inspection-ready state.

+ Cross trains in other areas including Vector Manufacturing, Manufacturing Sciences, Process Development, QC and QA to perform additional job functions, as necessary

+ Trains and leads other Technician I on all processes and equipment functionality

+ Responsible for assisting with startup activities in area of responsibility

+ Assists in the review & creation of operation documents by providing input to technical composition of documents

+ Effectively demonstrates understanding of cGMPs & applies to specific responsibilities


**Req** **uirements:**


+ Associates Degree with 4+ years of experience in a cGMP manufacturing environment

+ Bachelors degree with 3+ years of experience in a cGMP manufacturing environment

+ Strong organization skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently

+ Good attention to detail and ability to follow written procedures

+ Must be able to work in setting with biohazards and various chemicals.

+ Must be able to wear appropriate clean room attire (i.e., surgical masks) and all Personal Protective Equipment (PPE)


**Apply for Immediate Consideration**


**Schedule and interview with Athena** https://calendly.com/athp320/interview


**Text Athena at 714-868-5477 with any questions. Please be sure to include which job you are interested in.**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-07-04 Expires: 2022-09-03

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SeniorCell Manufacturing Associate

Kelly Services
Arcadia, CA 91007

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