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Supervisor, , Pilot Lab (Cell Culture, 2nd Shift) - BPD

Plats Gaithersburg, Maryland, USA Jobb-id R-048176 Datum inlagd 04/01/2019

The Supervisor is responsible for the daily supervision and training of operating personnel in the manufacture of clinical supplies in accordance with Current Good Manufacturing Practices (cGMP’s).

Qualifications

  • Requires a Bachelors degree in a scientific discipline or equivalent industry experience.
  • A minimum of 5 years experience in a large scale biotechnology manufacturing environment is required.

Shift: This will be 2nd shift - 2pm-11pm

Principal Duties

  • Responsible for the accurate and timely completion of clinical manufacturing campaigns and the associated cGMP documentation.
  • In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures.
  • Authors Deviations or supporting documentation.
  • Prepares annual performance evaluations for subordinates.
  • Authors Manufacturing Production Records (MPR’s), Standard Operating Procedures (SOP’s) and Solution Production Records (SPR’s).
  • Ensures the effective use of material, equipment, and personnel in the manufacture of clinical supplies.
  • Prepares daily operational schedule from Master Production Schedule.
  • Works on problems of moderate scope, where analysis of situations or data requires process and scientific knowledge and the ability to assess identifiable factors.
  • Supervises sub-group and actively works with other sub-groups to meet schedules or resolve problems.  Erroneous decisions or failure to achieve results will cause delays in schedules.
  • Frequently interacts with subordinates, and other production sub-groups, and functional peer groups at various management levels.  Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.
  • Has good interpersonal skills, is attentive and approachable.
  • Discusses problems with colleagues and senior personnel.
  • Maintains a professional and productive relationship with supervisor and co-workers.
  • Acts as mentor for less senior personnel and actively works to develop subordinates within the organization.
  • Provides expertise in operating and troubleshooting large scale upstream Cell Culture production equipment such as Bioreactor and Disk Stack Centrifuge. 


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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