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Production Supervisor - Operations

Plats Frederick, Maryland, USA Jobb-id R-063725 Datum inlagd 10/16/2019

AtAstraZeneca 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.

Main Responsibilities:

Daily supervising and performing on-the-floor operations pertaining to biologics manufacture in a cGMP environment (70-80% time on shop floor)

  • Coaching, counselling, training/development, discipline and recognition of direct staff, including performing annual performance reviews
  • Ensuring performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
  • Coach staff and intervene during operations when required to achieve on-floor performance expectations
  • Ownership of Tier 1, shift change meetings to coordinate cross-functional resource allocation needs for issues identified and maintain production targets
  • Executing production and resource schedule against operational plan

Daily off-floor support provided (20-30% off floor coordination)

  • Generating SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture.
  • Monitoring and creating documents and/or spreadsheets to support business reporting requirements
  • Final review of completed manufacturing documentation per compliance standards and established timelines
  • Collaborating with Manufacturing Process Lead to resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management
  • Participating and/or leading multi-functional project teams, as necessary
  • Participate in helping to evaluate and establish potential new interdepartmental procedures and practices
  • Other duties as assigned or identified
  • Knowledge
  • Knowledgeable of the current Code of the Federal Regulations (CFR’s) and Current Good Manufacturing Practices (cGMP’s)
  • Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management
  • Expert knowledge of electronic quality systems
  • Possesses strong verbal and written communication skills

Problem Solving

  • 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

Freedom To Act

  • Assignments are received in task-orientated terms. 
  • Provides direction to subordinates using established policies and precedents
  • Work is reviewed for soundness of judgment and overall quality and efficiency
  • Administers and executes policies and procedures that typically affect individual subordinate employees
  • Ability to make and act on routine decisions
  • Assess and provide options to management for process decisions that have a significant impact to the department
  • Plans and supervises execution of group’s day-to-day and week-to-week activities

Impact

  • Ensures that projects are completed on schedule following established procedures and schedules
  • Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources

Interpersonal Communication

  • Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher
  • Liaison normally involves specific phases of a project or operation
  • Contacts with outside vendors and senior management are infrequent and involve routine matters

Supervisory / Management Skills

  • Monitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
  • May perform, especially in staff or professional groups, ongoing operational tasks of organizational unit
  • Situational Leadership
  • Good organizational skills

Minimum Requirements:

  • BS/BA degree preferred in biological sciences or biotechnology/life sciences; Masters degree accepted.
  • Associates and High School Diploma acceptable with appropriate experience

Preferred years of experience

  • 5-7 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors
  • 3-5 years experience with Masters degree
  • 10-15 years experience with Associates Degree and 15+ years experience with High School education

Apply Now!

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 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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