Lead Manufacturing Technician
- Expired: September 25, 2022. Applications are no longer accepted.
Job Description: The Lead Manufacturing Technician is responsible for the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment. The Lead Manufacturing Technician is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products. In addition, a Lead Manufacturing Technician may be called upon as a project or process development leader.
- Bachelors Degree in the biologic sciences or bioengineering, with demonstrated technical experience in bioprocessing or tissue engineering.
- 5+ years experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment.
- 5+ years as a member of a manufacturing team and capable of managing manufacturing operations and leading by example. Capable of training and supervising other manufacturing technicians and able to lead in the absence of a Supervisor for a non-extended period of time.
- Strong understanding of GMP requirements, including FDA and EMA.
- Strong organizational, interpersonal, written and communication skills.
- Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines.
- Experience in a matrixed-reporting environment.
- Other tasks as assigned.
- Assists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA and EMA regulations, as applicable.
- Provides manufacturing of cell-based products and regulatory and process development support.
- Ensures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standards.
- Ensures that manufacturing efforts yield clinical trial products that meet predetermined criteria for quality and safety as determined by the relevant regulatory agencies.
- Maintains a strong culture of safety, quality, accountability, cost efficiency, on time delivery and customer service.
- Ensures facilities are maintained in a continuous state of readiness. Identifies and mitigates risks for the operation and timely brings to the attention of a supervisor.
- Ensures relevant manufacturing data are captured appropriately for supporting regulatory filings for clinical trials.
- May be called upon represent cell manufacturing facility during internal and external audits and to regulatory authorities.
- Analyzes manufacturing capacity and makes recommendations for organizational goals that align with capacity capabilities. Develops, maintains or adjusts organizational structure to adapt to changing business needs.
- Responsible for the development of annual operating plans, budgets and key programs designed to drive cost, efficiency, safety, quality and service.
- Performs regular analysis of production scheduling and capacity.
- Approves project schedules and any deviation from schedules and oversees root cause analysis of deviation from schedules.
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