Lead Cell Manufacturing Technician

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

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com.

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.

INDSCIC