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1+ months

Biomanufacturing Associate

Kelly Services
Raleigh, NC 27608
Kelly Science and Clinical is looking for an **Manufacturing Operations Associate** for a groundbreaking biopharmaceutical company in **Raleigh, NC.**


The Manufacturing Associate will be responsible for processes, cultures, cryopreserves, and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance with facility GMP and GLP practices.


**Responsibilities:**


+ Performs any and all required processing and testing required to produce and assess safe and efficacious products

+ Proficiently functions within cleanroom environments, ensuring personal and product safety

+ Consistently produces documentation with accuracy and clarity in accordance to Good Documentation Practices and Good Manufacturing Practices

+ Proficiently performs testing and assesses product content and safety according to companys established procedures

+ Responsibilities include but are not limited to cell/tissue culture and manipulation using aseptic techniques, as well as cleaning and sanitization activities to support the maintenance and ongoing use of the processing and filling spaces and equipment

+ Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints

+ Cryopreservation of cellular products using DMSO solution and controlled-rate freezers

+ Proficiently operate and maintain equipment according to designed procedures

+ Performs the monitoring and maintenance of critical equipment such as ultra-cold freezers, storage tanks, refrigerators, freezers, and incubators

+ Participates in clinical trial support and studies, may include but not be limited to sample preparation, sample shipping, media and reagent preparation

+ Applies high level understanding of processing principles and techniques to use good judgement and make appropriate decisions in the processing environment

+ Notifies Management of any deviation that may occur during processing or during equipment maintenance

+ Performs investigations for deviations and completes deviations and CAPAs (Corrective and Preventive Actions) in a timely manner

+ Supports outcomes of investigations including ownership and implementation of CAPAs (Corrective and Preventive Actions)

+ Initiates Change Controls for processes, documentation, equipment, etc.

+ Drafts and reviews SOPs and Master Batch Records (MBRs) related to the manufacturing of cellular batches according to GMP practices

+ Revises and updates documentation as needed to support ongoing compliance and process improvement activities

+ Perform and/or assist in the training and development of junior Associates

+ Supports or leads technology transfers into GMP manufacturing operations

+ Participates in the on-call program as requested

+ May provide direction to Manufacturing Associates I and II employees within the Clinical Manufacturing department(s).

+ May onboard and train new colleagues


**Core Competencies:**


+ Able to carry out responsibilities with little instructions on routine work and with detailed instructions on new projects or assignments

+ Able to work on problems of moderate scope where analysis of a situation/data requires review of a variety of factors

+ Exercise judgment to determine appropriate actions within defined procedures and practices

+ Analytical and problem-solving skills

+ Detail oriented with strong organizational skills

+ Strong written and oral communication skills

+ Ability to prioritize and multi-task is essential

+ Must be able work independently and as well as effectively within a team-oriented environment

+ Flexible and able to adapt to company growth and evolving responsibilities

+ Must be able to work during weekends, holidays and as required by the company


**Requirements:**


+ Associates or Bachelors degree in Biology or related life science degree or equivalency and 1 - 6 years manufacturing or laboratory experience in clinical laboratory, hematology, blood banking, and/or a cGMP manufacturing facility

+ Working knowledge of aseptic technique and working in a laboratory environment

+ Working knowledge of quality systems (Change control, Deviations, CAPA) preferred

+ Working knowledge of GMP and/or GLP regulations preferred

+ Cell processing experience preferred

+ Relevant computer skills (Microsoft Office, Outlook)


**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)

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Posted: 2021-08-27 Expires: 2021-10-07

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Biomanufacturing Associate

Kelly Services
Raleigh, NC 27608

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