Lead Cell Manufacturing Technician

2 weeks ago

Philadelphia, United States Proclinical Staffing Full time

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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