Lead Cell Manufacturing Technician -Contract - Philadelphia PA
Proclinical is seeking a Lead Cell Manufacturing Technician to guide and lead the team of Aseptic Manufacturing Technicians.
Primary Responsibilities :
This role requires a comprehensive understanding of manufacturing processes and principles. The successful candidate will be responsible for a variety of tasks;
including cleaning, sanitization, preparation and product fulfillment for commercial and clinical use. A background in cell culture, aseptic gowning, qualification and cleanroom operations is highly desirable.
Skills & Requirements :
- Bachelor's degree or some post-secondary education.
- Proven working experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments.
- Ability to mentor and provide best practices to other team members.
- Ability to work with ambiguity and manage constant change.
- Must be able to read, write and understand English for Good Documentation Practices.
The Lead Cell Manufacturing Technician's responsibilities will be :
- Develop a Subject Matter Expert-level understanding of GMP cell therapy manufacturing processes.
- Identify training needs and establish a feedback loop for continuous improvement.
- Deliver training sessions and maintain training documentation.
- Comply with quality standards and requirements.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Review documents, including executed Batch Records and Logbooks.
- Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
- Execute documentation Change Controls of SOPs, Batch records, etc., as needed.
- Support interdepartmental and departmental projects.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Attend or hold daily huddle meetings and escalate issues / concerns to Area Management for further investigation.
- Work in a cleanroom with biohazards, human blood components, and chemicals.
Compensation :
- $35 to $40 per hour
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