Director, Cell Culture Operations
Posted by Recruiter
Philadelphia area
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Date Posted: |
05/17/07 |
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Date Available: |
Now
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Descriptions: |
Responsible for management of cell culture production for Cell Therapeutics in a multi-product contract manufacturing facility under GMP / GTP regulations.
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Responsibilities: |
Technical
Knowledge of GMP and GTP production needs for various types of human cell therapies, ranging from autologous indications, to allogenic stem cells, embryonic and adult stem cells, as well as cancer cell vaccines. Knowledge of isolation of primary cells of various types.
Individual should have experience working with adherent cells.
Knowledge of GMP/GTP regulated Cell Culture operations and support systems are essential.
Experience with the use of different growth conditions and vessels for adherent and non-adherent cells: including flasks, cell factories, cell cubes, closed bags and cassettes. Hands on expertise needed for aseptic training, processing of cells, large-scale production processes.
Management and Supervisory
Specific responsibilities include scheduling and coordination of production process, ensuring the maintenance of production equipment and room cleaning/clearance, development and writing of Standard Operating Procedures and Master batch Records, commissioning and validation of processes and rooms, oversight of process development work prior to GMP production.
Demonstrated supervisory skills, including hiring and training, coordinating production team efforts. Responsible for hiring, training, supervising and evaluating staff for Cell Therapeutics group.
Contract Manufacturing and Team Experience
Needs to effectively supervise multiple high-paced cell culture projects to address compliance, customer and business needs in a timely manner. Must demonstrate a clear understanding of the contract manufacturing business.
Should have experience with extensive team led-projects working with internal and external clients and working closely with Project Management department. Interact with clients through the technical transfer and production and release phases for GMP/GTP production. Interacts with Facilities, Validation, Quality Assurance, QC- Environmental, Analytical testing groups, Process Development and Material Management groups.
Regulatory
A strong working knowledge of the regularity compliance requirements for the cell therapy and biologics are essential. Excellent knowledge of GMP and GTP regulations is required.
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Qualifications: |
A strong working knowledge of the regularity compliance requirements for the cell therapy and biologics are essential. Excellent knowledge of GMP and GTP regulations is required.
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Salary Range & Benefits: |
100-150K
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Contact Information |
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To Apply -- Contact: |
Transpacific Group, Inc.
Executive Search
transpacific@comcast.net
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