Philadelphia, USA
39 days ago
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

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