AstraZeneca Pharmaceuticals LP Supervisor, Pilot Production - Purification - BPD in Gaithersburg, Maryland

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Job Description:

This position is 2nd shift: 2pm-11pm

Supervisor:

Regularly works, under minimal supervision from area management, on non-routine assignments in functional area where the ability to assess/analyze identifiable factors, situations and/or data is required. Resolves daily operational issues within own functional area and escalates more complex issues to area management. Adheres to Good Manufacturing Practices and standard operating procedures. Is supervising individuals from their immediate team. Interacts regularly with subordinates, other production sub-groups, functional area peers, and area management.

Senior Supervisor:

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. Is supervising individuals from cross-functional teams. Interacts regularly with subordinates, other production sub-groups, functional area peers, and area management.

Qualifications:

Supervisor:

  • Bachelors degree in the sciences and 7+ years experience in a large- scale biotechnology manufacturing environment.

Senior Supervisor:

  • Bachelors degree in the sciences and 7+ plus years experience in a large-scale biotechnology manufacturing environment, including 2+ years supervisory experience, preferred.

Principal Duties:

Supervisor:

  • First line authority figure for process area. Responsible to initiate, monitor, and take appropriate actions related to process operations

  • Responsible for overseeing the accurate and timely completion of clinical manufacturing campaigns and the associated cGMP documentation

  • Direct/Assign junior staff (Tech 1 to Lead ) on daily/tactical tasks for process area

  • Ensures the effective use of material, equipment, and personnel in the manufacture of clinical supplies

  • Works with other supervisors to ensure consistency in the performance management process

  • Develops subordinates through use of IDP (Individual Development Plans), Career Architect and provided performance improvement and development tools.

  • In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures

  • Participates on and/or leads cross functional teams

  • Reviews and approve Manufacturing Production Records (MPR’s), Standard Operating Procedures (SOP’s) and/or Solution Production Records (SPR’s)

  • Prepares daily operational schedule

  • Ensures training records for subordinates are accurate and current

  • Hires and on-boards subordinates

  • Initiates and leads presentations/discussions of technical information concerning specific projects, schedules, etc.

  • Oversees the implementation and compliance with Medimmune’s safety standards

  • Demonstrates general knowledge of organizational excellence principals (e.g., process improvements and cost containment project)

  • Participates as a compliance (QA or SHE etc.) audit lead for area. Expected to support compliance audits regardless of shift or schedule.

  • Regularly participates in collaboration initiatives across MS

  • Interact cross functionally with internal Manufacturing Sciences support teams and other support groups (QA, QC, Facilities, etc.)

  • Routinely implements complex assignments to enhance quality and / or operational efficiency with minimal direction from mgmt.

  • Works on problems of moderate scope, where analysis of situations or data requires process and scientific knowledge and the ability to assess identifiable factors

Senior Supervisor:

  • 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

  • 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

  • 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 mgmt

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.