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Plats: Gaithersburg, Maryland, USA
Jobb-id R-055949
Datum inlagd: 07/15/2019

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:

Production Tech I: Bachelors degree and 0+ years experience OR Associates degree and 1-2 years experience OR high school diploma and 5+ years experience.

Production Technician II:

Bachelors degree and 2+ years experience OR Associates degree and 3-4 years experience OR high school diploma and 7+ years experience


Principal Duties - Tech I:

  • Operates bio-pharmaceutical manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, chromatography  skids,
  • single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing
  • instruments.
  • Performs SIP,  CIP  and manual cleaning and sanitization of equipment
  • Monitors critical process parameters and troubleshoots equipment during processing.
  • Performs daily manufacturing tasks per Standard Operating Procedures and
  • Manufacturing Production Records.
  • Performs in- process analytical instrument measurement  testing
  • Documents all manufacturing activities clearly and accurately per cGMP and regulatory requirements.
  • Prepares for processing by ensuring equipment and materials necessary are adequate and
  • available.
  • Ensures all production activities are completed in an aseptic, safe and compliant manor.
  • Interacts regularly with co-workers, senior personnel and supervisors in dynamic team environment to improve quality and process efficiency.

Principal Duties - Tech II:

  • Proficient in bio-pharmaceutical manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments.
  • Performs SIP, CIP and manual cleaning and sanitization of equipment
  • Monitors critical process parameters and performs first-line troubleshooting of equipment and processing.
  • Performs daily manufacturing tasks per Standard Operating Procedures and Manufacturing Production Records.
  • Performs in- process analytical instrument measurement testing
  • Documents all manufacturing activities clearly and accurately per cGMP and regulatory requirements.
  • Assist in forecasting, identifying and ensuring equipment, materials and set-up of process nec are adequate and available.
  • Ensures all production activities are completed in an aseptic, safe and compliant manor.
  • Interacts regularly with co-workers, senior personnel and supervisors in dynamic team environment to improve quality and process efficiency
  • Provides training to more junior staff, as requested
  • Assist in reviewing, authoring and provides feedback about Master Production Records and standard operation documents as needed, to accurately reflect process steps and capture process changes 
  • Assists in the execution of validation protocols, as requested

Purification Technical Principal Duties

  • Serve as a trainer for the CIP, P-Test, and SIP of product hold tanks
  • Serve as a trainer in Column Chromatography process operations, column packing, TFF (Tangential Filtration Flow) and basic analytical testing (e.g. Protein concentration, osmolarity, pH etc.)
  • Serve as a performer and trainer in SAP and Pi

Pilot Production Technician I
Tillverkning

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