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Lieu: Frederick, Maryland, États-Unis
ID de l'offre 13213381
Date de publication: 09/04/2019

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As aManufacturing Specialist in Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Scope:

The Manufacturing Specialist is responsible for reviewing and approving MPRs, and SPRs for equipment and procedures used in routine biologics manufacture:

  • VSCR approvals
  • Validation protocol approvals
  • Leads deviation investigations and CAPA identification; drive adherance to standard work and deviation/CAPA closure.
  • Implements innovative technological or efficiency programs/solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost-effective manner.
  • Partners with Quality Assurance to manage quality records and inspection readiness
  • Coordination with Training department to ensure appropriate training development and effective floor execution roll out
  • Primary Manufacturing Operations interface for New Product Introductions
  • Coordinating and ensuring successful completion of tech transfer projects/ activities for the Manufacturing Department

Main Responsibilities:

  • Expert knowledge of biopharmaceutical manufacturing processes, systems and equipment
  • Expert knowledge of electronic manufacturing and quality systems
  • Knowledgeable of manufacturing automation systems and their application
  • Knowledgeable of application and practices of current Good Manufacturing Practices (cGMP's), international regulatory requirements and guidelines (such as European directives, ICH guidelines and European and Japanese Pharmacopea requirements
  • Knowledgeable of late stage clinical and commercial manufacturing regulatory requirements and best practices
  • Knowledgeable in supply chain operations and business processes
  • Knowledgeable of troubleshooting/ root cause analysis tools
  • Working knowledge of Lean Manufacturing, Six-Sigma or other continuous improvement tools preferred
  • Represents the organization as the prime technical contact on programs and projects.
  • Ability to thoroughly investigate/ perform root cause analysis, identify potential issues and propose solutions through verbal and written communication
  • Ability to apply principles of logical or scientific thinking to a wide range of practical problems
  • Ability to apply common sense understanding and knowledge of when to stop and seek input and approval from management
  • Partner with MS and T, and Engineering and Manufacturing to solve process and equipment related problems
  • Limited oversight and minimal instructions needed on routine work: 
  • Assignments are received in objective-oriented terms.
  • Ability to make and act on routine decisions
  • Provides guidance to site teams and management based on organizational goals. 
  • Work is reviewed for soundness of judgment and overall quality and efficiency. 
  • Work typically impacts all teams at the FMC site.
  • Assesses and provides options to management for process decisions that have a significant impact.
  • Ensures that projects are completed on schedule following established procedures and schedules
  • Poor communication or erroneous decisions/ recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of time, human resources, and funds; and jeopardize future business activity.
  • Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills.
  • Contacts are frequent with individuals at high levels representing other departments, and/or representing outside organizations
  • Possesses strong verbal and written communication skills
  • Projects influence to assure alignment of site business processes with partners within MedImmune.
  • Monitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
  • Good organizational skills. First-line management skills for daily operation, Situational Leadership, Decision making skills
  • Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Education:

  • B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study required.

Experience:

  • 5-7 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors.
  • 3-5 years of experience with Masters’ degree.
  • 2-4 years of experience with PhD

Preferred:

  • MBA preferred. Lean/Six Sigma certification preferred.

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.

Manufacturing Specialist- Operations
Production

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