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Associate Director, Manufacturing Technology - United States  

Company managed [?] Still accepting applications
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Posted on : 01 June 2017

Project Description

Description:
  • Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. 
  • our company is seeking a highly-motivated individual with cell culture and drug product experience to work on innovative T cell therapy for cancer treatment.  
  • The Associate Director, Manufacturing Technical Services will manage technical team responsible for deviations, CAPAs, change control and front line support for our company’s commercial manufacturing site producing autologous T cell therapy products.

 

Key responsibilities:
  • Lead the technical team responsible for deviations, CAPAs, change control and front line support 
  • Investigate, identify root cause for critical deviations and determine CAPA for manufacturing 
  • Establish data analytics to serve as metrics 
  • Support incoming tech transfers from Product Sciences 
  • Author technical reports and protocols in support of cGMP activities 
  • In collaboration with Product Science evaluate and implement continuous improvement initiatives 


Qualifications:
  • Masters/Ph.D in Biochemistry, Chemical Engineering, Biotechnology or equivalent 
  • Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices 
  • Mastery of scientific and engineering principles 
  • Practical experience in GMP operations 


Skills:
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development 
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills 
  • Excellent interpersonal, verbal and written communication skills 
  • Ability to function efficiently and independently in a changing environment 
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description 
  • Well-developed computer skills 


Experience:
  • Must have 10+ years of pharmaceutical manufacturing, technology transfer or process development experience 
  • Pharmaceutical products GMP manufacturing experience is a must 
  • Cell culture or aseptic processing experience is a plus 
  • Previous experience with cell therapy products is a plus 
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus 
  • Proven track record of leading and managing cross functional teams 
  • Knowledge of data management tools and statistical process controls 
 


About Us:
  • Our company is an equal opportunity employer.
  • We are able to offer the opportunity to be part this successful, fast growing company.  A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.