Associate Scientist II / Scientist I, Fill-Finish Process Development- (Gaithersburg, MD) - Gaithersburg, MD | Biospace
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Associate Scientist II / Scientist I, Fill-Finish Process Development- (Gaithersburg, MD)

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
1/21/2017
Position Type:
Full time
Job Code:
R-001903
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Job reference: R-001903

Posted date: Dec. 07, 2016



   If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.  

   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.  As a Scientist I in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

   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.  

   Main Duties and Responsibilities  

 
       
  •      Fill-Finish Process Scientific Leadership: Provide oversight for fill-finish process development activities for multiple late-stage projects.    
  •    
  •      Review and approve process design and development strategies, risk assessments, characterization plans, engineering study protocols and reports, technical reports and regulatory filings.    
  •    
  •      Provide a consistent approach across projects by developing risk assessment tools, study protocols and report templates.    
  •    
  •      Develop platform container-closure systems, processes and equipment, and control strategies across multiple internal fill facilities and CMOs.    
  •    
  •      Mentor and teach process design, development and engineering concepts to staff members.    
  •    
  •      Provide technical rigor in experimental design and data analysis across projects.    
  •    
  •      Carry out ongoing academic and regulatory literature review, maintain a cutting edge scientific knowledge, and report findings to team.      
  •    
  •      Oversee the operation of a fill-finish pilot laboratory including vial and syringe filling and lyophilization capabilities.    
  •    
  •       Project Support: Serve as process SME on tech transfer teams.    
  •    
  •      Perform risk analyses and conduct laboratory or engineering studies to characterize processes.    
  •    
  •      Design process steps, establish an operational design space and control strategy.  Support engineering and clinical fills at GMP fill-finish sites.    
  •    
  •      Provide on-site support of fills, provide support to close non-conformances.  Regulatory writing responsibilities include supporting clinical and commercial filings.    
  •  

Requirements

   Essential Requirements  

 

   Education  

 
       
  •      Degree in chemical, pharmaceutical or mechanical engineering, chemistry, biochemistry, or a related engineering or pharmaceutical science field.    
  •  

   Experience  

 
       
  •    
  •    
  •      The Scientist I: PhD with no required experience, or a BS or MS degree  with >10 years of experience.    
  •  

   Knowledge  

 
       
  •      biopharmaceutical drug product development    
  •    
  •      fill-finish unit operations including formulation, mixing, filtration, fill and lyophilization    
  •    
  •      biopharmaceutical degradation pathways and mechanisms    
  •    
  •      QbD, experimental design, statistics, modeling    
  •    
  •      leadership, communication, teaching and mentoring    
  •    
  •      technical writing and documentation    
  •    
  •      cGMP, aseptic processing , and related regulatory literature    
  •    
  •      device assembly, labeling and packaging processes    
  •    
  •      packaging design, development and validation    
  •    
  •      ability to handle multiple ongoing work streams in an organized fashion    
  •  

   Desirable Requirements  

 
       
  •      Suitable experience may include development of FF, lyophilization, or device assembly processes.    
  •    
  •      A high degree of self-motivation, scientific curiosity, and scientific rigor is required.    
  •    
  •      Experience organizing and leading cross-functional teams is valuable.    
  •    
  •      Though this position is in Development, we will consider strong candidates with GMP processing experience, e.g. in technical services, project management, QA or validation.    
  •    
  •      We will also consider strong candidates from a device development or small molecule parenteral background.    
  •  

   Interpersonal Communication  

 
       
  •      Excellent writing, verbal and listening skills.  Presentations/reports to senior management and high-level industry audiences.    
  •  

   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.  

   *LI-Medi  

 

   ~BSP