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Process Development Group Leader

Company: ADMA Biologics
Location: Boca Raton
Posted on: May 14, 2022

Job Description:

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Process Development Group Leader in Boca Raton, FL! The incumbent will provide process development support for IgG Immunotherapy Production. They will provide updates to Process Development (PD) Management team on a regular basis to ensure compliance issues are being met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. Providing supervision of PD Technician(s). As a key member of the PD group provide support for Manufacturing, Quality Control/Quality Assurance, and Regulatory departments. PROCESS DEVELOPMENT:

  • Oversee/supervise routine PD activities utilizing the validated scale model. Oversee/supervise activities in single or multiple unit operations for PD studies. Record results in BPR utilizing the Doer/Reviewer model.
    • Provide support for technical issues related to the manufacturing process and product quality.
    • Write/Revise/Review Batch Production Records as necessary.
    • Maintain compliance in PD laboratory by ensuring all equipment calibration/IQ/OQ/PM status are current.
    • Participate in designing and planning scientific experiments to achieve corporate goals for existing projects.
    • Review and/or approve cGMP documentation (BPR) generated by other PD group members as necessary.
    • Maintain and review process development Batch Records for scale down process models.
    • Perform other activities as assigned by the PD Managers.
    • Assist manufacturing personnel in the execution of process development and process validation studies in cGMP production environment as necessary. QUALITY SYSTEMS:
      • Write/Revise/Review Standard Operating Procedures within the PD group as per cGXP guidelines.
      • Write/Review Quality System Documents for Deviations, Change Controls, CAPAs, etc. as necessary. HEALTH and SAFETY:
        • Maintain ADMA Safety Initiatives for the PD Lab
        • Maintain a clean and safe working environment
        • Ensure compliance following Safety Rules GROUP LEADER RESPONSIBILITIES:
          • Evaluate workload and assign tasks to direct reports on a daily basis
          • Prepare yearly evaluations of direct reports
          • Ensure direct reports compliance on all ADMA Safety, Quality and PD initiatives QualificationsEducation Requirements: Bachelor's degree in Science or Engineering. Experience Requirements: At least ten (10) years experience in a cGMP, Pharmaceutical/Biological manufacturing environment, familiarity with many aspects of process development is expected. Knowledge of FDA cGMP requirements is an essential pre-requisite for this position. Other Essential Knowledge: Ability to coordinate and complete complex projects; proficient in Microsoft Word, Excel, Power Point and Project; possess effective skills for developing, performing, evaluating, and/or troubleshooting; detail oriented, and excellent mathematical skills; Ability to plan and manage own work and performs other duties, responsibilities and projects as assigned. In addition to competitive compensation, we offer a comprehensive benefits package including:
            • 401K plan with employer match and immediate vesting
            • Medical, Vision, Life and Dental Insurance
            • Pet Insurance
            • Company paid STD and LTD
            • Company Paid Holidays
            • 3 Weeks' Paid Time Off (within the first year)
            • Tuition Assistance (after the first year)
            • Easily accessible to Tri-Rail
            • Company paid shuttle to the Boca Tri-Rail station ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit . ADMA Biologics is an Equal Opportunity Employer

Keywords: ADMA Biologics, Boca Raton , Process Development Group Leader, Other , Boca Raton, Florida

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