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Lead Pilot Production Technician - BPD

Location Gaithersburg, Maryland, United States Job ID R-058127 Date posted 08/08/2019

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  


Cell Culture Technical Principal Duties:

  • Prepare stainless steel and disposable bioreactors and tanks to include Pressure Test, CIP, SIP, and Centrifuge Harvest
  • Use aseptic technique to perform cell banking operations
  • Prepare and charge the LN2 dewar for vial shipment
  • Proficient in the operation of all area specific production equipment such as disposable and stainless steel bioreactors, tanks, cell banks, LN2 charging station, harvest operations, etc.


Support Services Technical Principal Duties:

  • Weigh and checks raw materials, assemble and clean process equipment, monitor processes
  • Perform SIP, CIP and manual cleaning and sanitization of equipment 
  • Preparation and filtration of production scale buffer and media solutions.
  • Proficient in the operation of all area specific production equipment such as glass washers, autoclaves, fixed and portable stainless steel tanks, etc.

All Stream Technical Principal Duties:

  • Proficient in inoculum expansion processes utilizing aseptic technique.
  • Proficient in the set up and operate disposable RM tabletop bioreactors and single use production bioreactors up to 3 x 200L scale. 
  • Serves as trainer in all purification activities to include column packing, column chromatography, TFF, and bulk fill processes.
  • Serves as a trainer of filtration of production scale buffer solutions, media solutions, and weigh and check raw materials.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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