Job Title: Manufacturing Specialist (contract)
Location: Houston, TX
Rate: $36-40/hr.
Schedule: Day Shift; occasional weekend work may be required
Duration: 12 months

About the Company
Kelly Scientific is partnering with a clinical-stage biotechnology company focused on developing life-changing genetic medicines for patients and families affected by rare neurological diseases.

Position Overview
We are seeking (2) Manufacturing Specialists to support the production of gene therapy products. The Manufacturing Specialist will perform hands-on manufacturing activities supporting the production of preclinical and clinical biopharmaceutical products and help maintain a reliable supply of materials for ongoing clinical trials.
The level of the position will be determined based on the candidate’s relevant education, technical experience, and GMP manufacturing background.

Responsibilities

• Operate manual, semi-automated, and automated equipment in support of routine production of preclinical and clinical biopharmaceuticals
  

• Perform large-scale cell culture using single-use disposable bioreactor systems
  

• Perform viral vector purification using process-scale chromatography equipment
  

• Prepare buffer solutions
  

• Stage equipment and raw materials in production suites
  

• Support and conduct non-critical deviation investigations, including gathering relevant information, assisting with root cause analysis, documenting investigation findings, and supporting appropriate corrective and preventive actions (CAPAs) in collaboration with Quality and cross-functional teams
  

• Assist with other production-related activities such as validation, data collection, inventory management, and maintenance of process equipment
  

• Perform cleaning of facility and unit process equipment
  

• Write and review SOPs and change control documents for manufacturing work areas
  

• Ensure proper documentation is completed to meet quality system requirements
  

• Participate in facility safety programs
  

• Resolve technical problems through collaboration with internal teams and external resources, including vendor support

Additional Responsibilities for Advanced Roles

• Author technical documentation such as summary reports
  

• Lead project meetings

Required Qualifications
Education

• Bachelor’s degree in Biology, Biotechnology, or a related scientific field

Experience

• Biopharmaceutical manufacturing experience in a GMP-regulated environment is preferred but not required
  

• Experience in upstream and/or downstream manufacturing processes is strongly preferred, including experience with:
  

  • Single-use bioreactor systems
    

  • Cell culture
    

  • Aseptic processing and sterile operations
    

  • Biosafety cabinets
    

  • Process-scale chromatography
    

  • Tangential Flow Filtration (TFF)
    

  • Buffer preparation
    

  • Viral vector manufacturing or purification
    

Knowledge & Skills

• Working knowledge of cGMP requirements and regulated manufacturing environments
  

• Understanding of deviation investigations, root cause analysis, CAPAs, and other applicable GMP quality systems
  

• Understanding of complex manufacturing equipment and process instrumentation
  

• Strong aseptic technique and attention to contamination control
  

• Ability to accurately follow written procedures, protocols, and manufacturing instructions
  

• Ability to develop or revise procedures when required
  

• Comfortable performing repetitive laboratory/manufacturing tasks, including pipetting
  

• Strong attention to detail and commitment to accurate documentation
  

• Ability to communicate and collaborate effectively with personnel across multiple departments and levels of the organization
  

• Ability to troubleshoot routine technical issues and escalate appropriately

Cleanroom & Physical Requirements

• The majority of work will be performed in a GMP manufacturing cleanroom environment
  

• Must be comfortable working in controlled environments, including areas operating up to ISO 5 / Grade A following appropriate training
  

• Must be willing and able to follow gowning requirements, which may include coveralls, face masks, shoe covers, hair/beard nets, and other PPE
  

• Ability to lift up to 50 lbs. with assistance
  

• Work may involve exposure to high-pressure gases, flammable materials, cryogenic operations, and chemical hazards including strong acids and bases
  

• Must consistently follow all applicable safety, environmental, and GMP procedures

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