Cell and Gene Therapy Manufacturing Specialist
1 week ago
Manufacturing Associate, Cell and Gene Therapy
Proclinical is in search of a committed Manufacturing Associate specializing in Cell and Gene Therapy.
Key Responsibilities:
This position is centered around the production of Master and Working Cell Banks, as well as conducting activities within production environments to facilitate the manufacturing of Cell & Gene Therapy products. The successful candidate will possess a comprehensive understanding of regulatory standards and have practical experience in aseptic methodologies and current Good Manufacturing Practices (cGMP).
Qualifications:
- Associate's or Bachelor's degree, ideally in a scientific discipline, accompanied by relevant professional experience
- Proficiency in cell culture techniques
- Familiarity with aseptic practices
- Capability to operate in a laboratory environment with biohazards and various chemicals
- Willingness to utilize appropriate personal protective equipment (PPE) as necessary
- Strong grasp of Good Laboratory Practices and Good Manufacturing Practices
Responsibilities of the Manufacturing Associate for Cell and Gene Therapy include:
- Overseeing and ensuring the effectiveness of aseptic techniques while adhering to compliance standards
- Providing training, guidance, and mentorship on fundamental aseptic operational methods
- Identifying gaps in aseptic techniques and implementing enhancements
- Operating and maintaining equipment, as well as performing complex troubleshooting
- Assisting in the sourcing and procurement of standard, new, and intricate equipment
- Preparing solutions and materials, analyzing outcomes, and resolving issues
- Engaging in and executing technical transfer activities
- Conducting validation activities both in-house and offsite, contributing to and reviewing validation documentation
- Coordinating the receipt and organization of materials, and conducting material procurement tasks
- Adhering to compliance and regulatory requirements along with current Good Manufacturing Practices (cGMPs)
- Authoring and enhancing the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
- Training others on SOPs, equipment, all unit operations, and non-manufacturing SOPs and systems
- Leading and supervising the manufacturing process
Compensation:
- $21 - $26 per hour
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Philadelphia, Pennsylvania, United States Proclinical Staffing Full timeCell and Gene Therapy Manufacturing Specialist - Contract PositionProclinical 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...
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