Cell and Gene Therapy Manufacturing Specialist

1 week ago


Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

Cell and Gene Therapy Manufacturing Specialist - Contract Position

Proclinical Staffing is in search of a skilled Manufacturing Specialist focused on Cell and Gene Therapy.

Key Responsibilities:

This position is centered on the production of Master and Working Cell Banks, as well as executing tasks within production environments to facilitate the creation of Cell & Gene Therapy products. The successful candidate will possess a robust understanding of regulatory standards and have hands-on experience with aseptic processes and current Good Manufacturing Practices (cGMP).

Qualifications:

  • Associate's or Bachelor's degree in a relevant scientific discipline, complemented by pertinent work experience
  • Proficiency in cell culture techniques
  • Familiarity with aseptic methodologies
  • Capability to operate in a laboratory environment with biohazardous materials and various chemicals
  • Willingness to utilize necessary personal protective equipment (PPE)
  • Strong grasp of Good Laboratory Practices and Good Manufacturing Practices

Responsibilities of the Manufacturing Specialist include:

  • Overseeing and ensuring the efficacy of aseptic techniques in compliance with established standards
  • Providing training, guidance, and mentorship on fundamental aseptic operational methods
  • Identifying deficiencies in aseptic techniques and implementing corrective measures
  • Operating and maintaining laboratory equipment, including troubleshooting complex issues
  • Assisting in the procurement of standard and specialized equipment
  • Preparing solutions and materials, analyzing outcomes, and addressing challenges
  • Engaging in technical transfer activities
  • Conducting validation activities both on-site and off-site, contributing to the review of validation documentation
  • Coordinating the receipt and organization of materials, as well as executing procurement tasks
  • Adhering to compliance and regulatory standards, including current Good Manufacturing Practices (cGMPs)
  • Drafting and enhancing the efficiency of Standard Operating Procedures (SOPs) and Batch Records (BRs)
  • Training personnel on SOPs, equipment usage, and all operational and non-manufacturing procedures
  • Leading and managing the manufacturing workflow

Compensation:

  • $21 - $26 per hour

Proclinical Staffing is a dedicated employment agency and recruitment firm, offering job opportunities within leading pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Proclinical Staffing is an equal opportunity employer.



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