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    Senior Cell Manufacturing Associate - Philadelphia, United States - Proclinical

    Proclinical
    Proclinical Philadelphia, United States

    3 weeks ago

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    Contract
    Description

    Senior Cell Manufacturing Associate - Contract - Onsite

    Proclinical Staffing is seeking a Senior Cell Manufacturing Associate to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.

    Skills & Requirements:

  • Bachelor's degree or some post-secondary education.
  • 3+ years of 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
  • Proactive, results-oriented, self-starter with experience in a complex manufacturing environment
  • Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
  • Ability to mentor and provide best practices to other team members.
  • Must be able to work with ambiguity - ready to change gears and plans quickly and manage constant change.
  • Proficient with computers and Microsoft (Excel, Word, Outlook) programs.The Senior Cell Manufacturing Associate will:
  • Develop a Subject Matter Expert (SME)-level understanding of GMP cell therapy manufacturing process(es).
  • Assists with identifying training needs, and establishing a feedback loop to ensure continuous improvement.
  • Deliver training sessions and ensure training documentation is maintained.
  • Understand and comply with quality standards and requirements as documented.
  • Ensure training schedules meet company production and quality targets.
  • Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
  • Perform document review, including executed Batch Records and Logbooks.
  • Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
  • Execute documentation Change Controls of SOPs, Batch records, etc., as needed.
  • Support interdepartmental and departmental projects in a contributor capacity.
  • Supports technical transfer and additional research-level testing activities as needed.
  • May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Completes recording of data to comply with regulatory requirements.
  • Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.Compensation:

    $35 hourly

    If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) or

    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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