Senior Manufacturing Associate - (Frederick, MD) - Frederick, MD | Biospace
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Senior Manufacturing Associate - (Frederick, MD)

MedImmune, LLC

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Location:
Frederick, MD
Posted Date:
5/24/2017
Position Type:
Full time
Job Code:
R-007125
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Frederick, Maryland, United States
Job reference: R-007125

Posted date: May. 09, 2017

                                                     
                           


 

   At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Senior Manufacturing Associate in Frederick, MD you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

   Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.  

   Main Duties and Responsibilities  

   As the Senior Manufacturing Associate, you will be responsible for supporting tech transfer initiatives (authoring of batch production records and related non-conformances) and implementing technical or efficiency projects within the function.    In this role, you will be responsible for the following:  

 
       
  •      MPR generation and revision    
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  •      On the floor support for execution of process changes    
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  •      Training on documents and process changes    
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  •      Document review and coordination of changes with production area    
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  •      Support specialists/supervisors as needed    
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  •      Support investigations    
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  •      Supporting projects as needed    
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  •      Point of contact for cross department request    
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  •      Reviewing source documents (QCTP, FFR, PD, etc) to ensure alignment with manufacturing capabilities    
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  •      Troubleshooting process and equipment failures    
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  •      Recipe review and testing    
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  •      Label generation and revisions    
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  •      Support new equipment implementation    
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  •      Identify process improvements (Safety/Cost/Efficiency)    
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  •      Support and write VSCRs, CAPAs, NCs, etc    
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Requirements

   Essential Requirements  

   Knowledge  

 
       
  •      Contributes to the development of new concepts, techniques, and standards    
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  •      Considerable knowledge of cGMP standards, and the current code of Federal Regulations (CFR)    
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  •      Considerable knowledge to perform trouble shooting and root cause analysis    
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  •      Complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered    
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  •      Equipment knowledge to perform first line trouble shooting and root cause analysis    
  •  

   Problem Solving  

 
       
  •      Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.    
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  •      Develops solutions to complex problems requiring ingenuity and creativity/innovation.    
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  •      Ability to deal with problems involving a few concrete variables in standardized situations    
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  •      Ensures solutions are consistent with organization’s objectives    
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   Preferred Education  

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

 
       
  •      5-7 years of work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors    
  •    
  •      3-5 years of work experience with Master’s Degree    
  •  

   Desirable Requirements  

   Freedom to Act  

 
       
  •      Work is performed without appreciable direction and dependent on level, limited supervision and minimal instructions needed on routine work    
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  •      Depending on level and experience, expresses latitude in determining objectives and approaches to assignment or may require some instructions given on new lines of work or special assignments    
  •  

   Impact  

 
       
  •      Ensures that projects are completed on schedule following established procedures and schedules    
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  •      Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources    
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  •      Errors may be difficult to detect and would normally result in loss of material or equipment down-time    
  •  

   Interpersonal Communication  

 
       
  •      Contacts are frequent with individuals representing other departments, and/or representing outside organizations    
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  •      Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation    
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  •      Good communication skills, both verbal and written, and effective presentation skills are preferred    
  •  

   Supervisory / Management Skills  

 
       
  •      Good organizational skills    
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  •      Basic first-line management skills for daily operation    
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  •      Situational Self Leadership    
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  •      Decision making skills    
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   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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.  

   ~bsp  

 

   *LI-MEDI