Lead Pilot Production Technician/Pilot Production Technician III - BPD

Astrazeneca Gaithersburg , MD 20877

Posted 3 months ago

As a pilot production associate in the Clinical production team within Biopharmaceutical Development, you'll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role you will take an adaptable, science driven approach to everything you do. You will become an integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skillsets to perform large scale clinical development activities through hands-on training. You will join a collaborative and driven team in a world class biopharmaceutical company that is driving disruptive innovation in the industry.

Qualifications

Tech III: Bachelors degree and 4+ years experience OR Associates degree and 5-6 years experience OR high school diploma and 9+ years experience.

Lead Tech: Bachelors degree and 6+ years experience OR Associates degree and 7-8 years experience OR high school diploma and 11+ years experience.

Tech III Principal Duties:

  • Assists more junior manufacturing personnel to comply with Standard Operating Procedures (SOP's), Master Production Records (MPR's), and Solution Production Records (SPRs)

  • Serves as the "Subject Matter Expert" in unit operation

  • Provides training to more junior staff, when needed

  • Mentors others for the unit operation

  • Routinely monitors manufacturing processes and recognizes potential process issues as they arise; proactively escalates identified issues to senior staff

  • Troubleshoots problems and recommends potential solutions to those in more senior roles

  • Contributes to the development of new concepts, techniques, and standards

  • Reviews Master Production Records for accuracy and completion of process steps, as requested

  • Leads unit operations or projects, as requested

Purification Technical Principal Duties

  • Proficient in the operation of all area specific production equipment such as column chromatography operations, Tangential filtration formulation and column packing

Lead Tech Principal Duties:

  • Assigns daily tasks to more junior production technicians

  • Accurately analyzes and processes scientific data

  • Ensures the completeness and accuracy of manufacturing documentation per approved procedures

  • Reviews Master Production Records for accuracy and completion of process steps

  • Works with more senior manufacturing personnel to improve and optimize manufacturing methods

  • Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary

  • Serves as the lead investigator for non-conformances, as requested

  • Serves as the "Subject Matter Expert" in area operations

  • Lead unit operation or projects

  • Provides training and operational guidance to more junior staff

  • Serves as the area supervisor when the Supervisor is unavailable

  • Schedules projects in accordance with production timelines, as requested

  • Conducts gap analysis on scientific process and develop process improvement plans

Purification Technical Principal Duties

  • Perform SIP,CIP, and ptest on tanks

  • Severs as a SME (subject matter expert) in Column Chromatography operations, TFF (Tangential Filtration Flow) and column packing

  • Proficient in SAP and pi process book

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VIEW JOBS 2/7/2020 12:00:00 AM 2020-05-07T00:00 As a pilot production associate in the Clinical production team within Biopharmaceutical Development, you'll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role you will take an adaptable, science driven approach to everything you do. You will become an integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skillsets to perform large scale clinical development activities through hands-on training. You will join a collaborative and driven team in a world class biopharmaceutical company that is driving disruptive innovation in the industry. Qualifications Bachelors degree and 6+ years experience OR Associates degree and 7-8 years experience OR high school diploma and 11+ years experience. Principal Duties * Assigns daily tasks to more junior production technicians * Accurately analyzes and processes scientific data * Ensures the completeness and accuracy of manufacturing documentation per approved procedures * Reviews Master Production Records for accuracy and completion of process steps * Works with more senior manufacturing personnel to improve and optimize manufacturing methods * Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary * Serves as the lead investigator for non-conformances, as requested * Serves as the "Subject Matter Expert" in area operations * Lead unit operation or projects * Provides training and operational guidance to more junior staff * Serves as the area supervisor when the Supervisor is unavailable * Schedules projects in accordance with production timelines, as requested * Conducts gap analysis on scientific process and develop process improvement plans Purification Technical Principal Duties * Perform SIP,CIP, and ptest on tanks * Severs as a SME (subject matter expert) in Column Chromatography operations, TFF (Tangential Filtration Flow) and column packing * Proficient in SAP and pi process book Astrazeneca Gaithersburg MD

Lead Pilot Production Technician/Pilot Production Technician III - BPD

Astrazeneca