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QC Sr. Microbiologist II - United States  

Company managed [?] Still accepting applications

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. 
  • We are seeking a highly motivated individual to join us as a QC Sr. Microbiologist II 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 providing Quality Control Technical support to QC and Manufacturing.



Responsibilities
  • Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability) 
  • Establish user requirements for purchase, qualification of company’s QC equipment and work with internal and external resources to maintain equipment in an optimal state 
  • 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    
  • 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. 
  • Perform other duties as assigned. 



Requirements:
  • Bachelor's degree or advanced degree in Microbiology or related discipline 
  • Six to 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility.
  •  A minimum of  3 years’ experience with method and equipment validation within the biotechnology or pharmaceutical industry 
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs. 
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell therapy product 
  • Strong knowledge of  Environmental Monitoring requirements and tests (viable and  non-viable),   Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals 
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP) 
  • Experience in performing risk assessments 
  • Strong knowledge of Quality Control processes, GMPs,  and Microbiological method validation 
  • Extensive experience in conducting laboratory and environmental excursion investigations. 
  • Strong knowledge of  Equipment IQ/OQ/PQ/PV 
  • Proficient in MS Word, Excel, Power Point and other applications 
  • Ability to communicate and work independently with scientific/technical personnel. 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description 
  • Ability to think critically and demonstrate troubleshooting and problem solving skills 
  • Excellent interpersonal, verbal and written communication skills 
  • Experience managing projects 
  • Experience drafting qualification/validation protocols and reports.  
  • Experience executing equipment and method qualifications independently.