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Supervisor, QC Microbiology El Segundo United States,  

Job Score (company)


Posted on : 11 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 based in Santa Monica, CA.
  • We are seeking a highly motivated individual to join us as a QC Microbiology Supervisor in our new commercial cell therapy production center.
  • You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy.
  •  In this role you will be responsible for the day to day oversight of the QC Microbiology team and Sample Management team (Sunday through Thursday, second shift).
  •  You will also be responsible for environmental monitoring program, raw material testing, final product testing and sample management program. 



Responsibilities (include but are not limited to):
  • Supervision of all QC Micro laboratory testing 
  • Supervision of sample receipt, retain storage and disposal 
  • Sustain environmental monitoring program for our company
  • Management and optimization of the Aseptic gowning training and qualification program 
  • Management of  QC Microbiology training program 
  • Work with QC raw materials team to establish specifications and testing process of raw materials.  
  • SME on investigations of sterility and environmental excursions 
  • Monitor and trend data  
    • Assemble reports on findings from environmental monitoring of  our company's cGMP facility.  
    • Frequently update management on environmental trends.  Implement corrective action plans when necessary 
    • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. 
    • Generation of CoAs for product release   
  • Develop, revise and review SOPs, qualification/validation protocols and reports 
  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures    
  • Provide updates at daily and weekly meetings 
  • Monitor the GMP systems currently in place to ensure compliance with documented policies 
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate 
  • Gather metric information for use in continuous improvement of areas of responsibility 
  • Other duties as assigned 



Requirements:
  • Bachelor's degree or advanced degree in Microbiology or related discipline 
  • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment. 
  • A minimum of 7 years  experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.  A minimum of  1 year experience supervising/managing microbiology  and environmental monitoring labs within the biotechnology or pharmaceutical industry 
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product 
  • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes 
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs. 
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) 
  • Quality Control, GMPs, microbiological method development and validation 
  • Strong knowledge of GMP, SOPs and quality control processes 
  • Strong data integrity knowledge and practices. 
  • Identifying, writing evaluating and closing OOS s and investigations 
  • Strong knowledge of aseptic manufacturing and EM processes 
  • Equipment and utility IQ/OQ/PQ/PV 
  • Proficient in MS Word, Excel, Power Point and other applications 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
 

Locations

El Segundo CA

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