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Lead Production Operator
Ref No.: 18-02170
Location: west chester, Pennsylvania
Position Type:Direct Placement
Start Date: 02/28/2018
  • Lead the execution of all clinical drug product (DP) batches; directly accountable for right first time quality.
  • Perform all activities supporting the production of sterile DP, including but not limited to: operation of the filling line, formulation of buffers and dilution, preparation of components and supplies including use of the autoclave and part washer, documentation (batch records, logbooks, etc), routine in-process analytical testing, visual inspection, and batch record review.
  • Perform front line supervision of shared plant manufacturing resources and DPO product scientists during GMP clinical production.
  • Provide training on SOP's, aseptic technique, and activity-based competency assessments.
  • Author and maintain SOP's required to support clinical GMP production of sterile DP.
  • Coordinate calibration and preventive maintenance activities.
  • Supports Deviation investigations and implementation of CAPA's.
  • Supports and executes ongoing validation activities and change controls.
  • Supports the development of batch records, test protocols, sampling plans.
  • Supports operation of a non-GMP development Lab, including reference standards, tox fills, and other early product development studies.
  • Coordinate resource allocation/sharing with BMF upstream, downstream, and media/buffer prep managers.
  • Work with formulation scientists to facilitate tech transfer of products from the lab into the clinical DP facility.
  • Mentor less experienced staff on sterile manufacturing operations and GMP; help to build institutional knowledge around sterile fill/finish within WC and the BMF.
  • Maintain the DP facility in an "audit ready” state at all times, including facilities and documentation.
  • Supports technical troubleshooting of the filling line and resolution of atypical events during clinical manufactures.
  • Develop and maintain Training curriculums
  • Supports internal & external audits.
  • Supports ongoing continuous improvement / risk assessment activities required to operate and maintain the GMP DP facility.
  • Supports upstream/downstream/cell banking manufacturing operations as-needed.
  • Hands-on production experience in aseptic processing and the manufacture of sterile drug products.
  • Thorough understanding of GMP's and the regulatory requirements for working in a GMP environment.
  • Basic understanding of microbiology and HVAC as they relate to the manufacture of sterile drug products.
  • Excellent planning, verbal and written skills; proficiency in good documentation practices essential.
  • Highly motivated, dynamic individual, with ability to work both independently and in a team environment, to build productive relationships within and across departments.
  • Proficient in Microsoft Office Suite of Programs.
  • BS degree in a related field, or equivalent experience.
  • Leadership/supervisory experience in a GMP environment.
  • Familiarity with the complex technical equipment used in the production of sterile drug products.
  • Ability to use root cause analysis to develop robust solutions to technical and process manufacturing issues.
  • Experience in buffer formulation and dilution, equipment troubleshooting & repair, and/or manual visual inspection of parenteral products a plus.