Proclinical Staffing | Bioprocessing Associate II

5 days ago


philadelphia, United States Proclinical Staffing Full time

Bioprocessing Associate II, Cell & Gene Therapy - Contract - Philadelphia PA

Proclinical is seeking a dedicated Bioprocessing Associate II to focus on Cell and Gene Therapy.

Primary Responsibilities:

This role will be responsible for the manufacture of Master and Working Cell Banks, supporting the production of Cell & Gene Therapy products, and ensuring final product fills adhere to current Good Manufacturing Practices (cGMPs).

Skills & Requirements:

  • High School diploma alongside 6+ years of relevant experience or an Associate's/Bachelor's degree in a science-related field with 1+ years of relevant experience.
  • Basic technical knowledge in the pharmaceutical and biotechnology industry.
  • Fundamental engineering and mechanical knowledge applicable to manufacturing.
  • Experience with facility start-ups and technical transfer activities.
  • Proficiency in using support systems and basic Microsoft applications.
  • Strong understanding of cGMP compliance and regulatory requirements.
  • Ability to train and mentor others, and work independently on basic tasks and processes.

The Bioprocessing Associate II's responsibilities will be:

  • Apply and train others in aseptic techniques, ensuring compliance and correcting practices as needed.
  • Operate, maintain, and troubleshoot equipment, identifying needs for corrective maintenance.
  • Assist with sourcing and purchasing standard equipment.
  • Prepare solutions and materials, and manage material procurement activities.
  • Participate in facility start-ups and technical transfer activities, providing feedback and ensuring GMP compliance.
  • Execute and review validation activities and documentation.
  • Schedule, receive, and organize materials, creating and revising material documents.
  • Use support systems (e.g., LIMS) proficiently and act as a subject matter expert.
  • Collect, record, analyze, and interpret scientific and process data, communicating findings to stakeholders.
  • Follow and improve Standard Operating Procedures (SOPs) and Batch Records (BRs), training others as needed.
  • Participate in the development of technical documents and continuous improvement initiatives.
  • Support regulatory inspections and client audits, coordinating with internal groups to resolve issues.

Compensation:

  • $22 to $26 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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