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Senior Manager/Manager, Pilot Production - BPD

Lieu Gaithersburg, Maryland, États-Unis Job ID R-065647 Date de publication 11/11/2019

Regularly works on non-routine manufacturing assignments across two or more functional areas where the ability to assess/analyze identifiable factors, situations and/or data is required.  Works under minimal supervision to resolve daily operational issues across multiple functional areas.  Escalates significantly complex issues to area management.  Adheres to Good Manufacturing Practices and standard operating procedures.  Manages individuals from cross-functional teams. Interacts regularly with subordinates, other production sub-groups, functional area peers, and area management.  Serves as product/process or equipment champion in the introduction and implementation of new equipment, innovative technologies, and novel products from concept through bench scale, scale-up areas and cGMP manufacturing.

Qualifications

Manager: Bachelor’s degree in the sciences preferred and a minimum of 8+ years of experience to include downstream process development and pilot-scale biologics manufacturing. 2+ years supervisory experience is preferred.

Senior Manager: Bachelor’s degree in the sciences preferred and a minimum of 10+ years of experience to include downstream process development and pilot-scale biologics manufacturing.

Principal Duties

  • Responsible for overseeing the accurate and timely completion of clinical manufacturing campaigns and the associated cGMP documentation across multiple areas
  • Ensures the effective use of material, equipment, and personnel in the manufacture of clinical supplies across multiple areas
  • Assess the impact of changes and/or routine schedule across multiple areas
  • Approves MPRs, SOPs, and SPRs
  • Formulates and recommends manufacturing policies, programs and procedures
  • Serves as product/process or equipment champion in the introduction and implementation of new equipment, innovative technologies, and novel products from concept through bench scale, scale-up areas and cGMP manufacturing
  • Expected to spend time evaluating the process the bench, in a scale-up facility, and in cGMP manufacturing area.  Interact with development, tech transfer and process scale up staff to assure seamless transition of product, process, or equipment implementations as necessary
  • Actively works with area management to develop schedules and resolve problems
  • Participates on and/or leads cross functional teams   
  • Effectively utilizes results-driven tools to improve operational efficiencies
  • Direct/Assign Junior staff.   Provide guidance as need in absence of mgmt. to appropriate process area
  • Facilitates investigations and approves non-conformances
  • Cross Functional team membership in BPD providing subject matter expertise
  • CMC team membership as appropriate
  • Routinely handles complex tasks and expected to form teams and groups to handle multiple level assignments of long duration or complexity
  • Assess the impact of changes to schedules across multiple areas
  • Routinely identifies and implements complex assignments to enhance quality and / or operational efficiency with minimal direction from management



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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