BrightOwl Loader Loading

Senior Manager, Quality Control Microbiology - United States  

Company managed [?] Still accepting applications

Posted on : 03 July 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 QC Microbiology, Senior Manager to manage the company QC Microbiology Department.  

 

Responsibilities (include but are not limited to):
  • Establish, validate and sustain environmental monitoring program for our company sites 
  • Develop, revise and review SOPs, qualification/validation protocols and reports 
  • Establish user requirements for purchase, qualification of our company's QC microbiological and equipment.  
  • Work with internal and external resources to maintain equipment in an optimal state 
  • Create working schedule for EM and QC microbiology lab in advance 
  • Revise and modify EM and PM SOPs per USA and EU guidelines 
  • Assemble data and write reports on findings from environmental monitoring of our company’s cGMP facility 
  • Monitor and trend data for EM and PM readings.  Update management on environmental trends.  Implement corrective action plans when necessary 
  • Assist in the preparation of dossiers and data packages for interactions between our company  and Regulatory agencies and interact with agents from Regulatory agencies and participate in Pre-Approval and post approval inspections 
  • 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 
  • Monitor the training records for the lab personnel. Make sure that % training completion rate is >90% 
  • Gather metric information for use in continuous improvement of areas of responsibility 
  • Conduct audit of internal testing labs and outside testing labs
  • Give weekly updates to your manager on time 
  • Prepare monthly performance metrics by first week of every month. 
  • Interact with the QC Laboratory personnel to plan and schedule testing at scheduled time points 
  • Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.  
  • Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.  
  • Perform other duties as assigned as on need basis 
 


Requirements:
  • Ph.D. Micro biologist preferred with 8-10 years or MS with 10 – 12 years as Microbiologist in a pharmaceutical or in other FDA regulated environment   
  • Demonstrated successful management of Environmental monitoring, Personnel monitoring in manufacturing suites and successful management of QC Microbiology labs 
  • Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin and Gram Stain), ELISA and other routine chemical tests and strong experience in managing testing by compendial methods 
  • Deep understanding of experimentation and data analysis and data trending using different statistical software packages 
  • General understanding of pharmaceutical GMPs and 21CFR Part 11, EU and Japanese pharmaceutical  regulations 
  • Experience in data management, change control, GMP and compliance. 
  • Excellent written and verbal communication skills and experience interacting with people from a wide   range of skill levels and experience.  
  • Ability to communicate complex scientific findings and recommendations in one-on-one discussions and in departmental meetings. 
  • Excellent technical writing experience such as SOPs, protocols, and reports, and writing analytical sections on microbilogical methods for Regulatory Filings 
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment. 
  • Strong computer, scientific, and organizational skills.  Ability to work independently and as part of a team with internal and external teams with excellent communication skills 
  • Exceptional analytical skills to evaluate the importance and urgency of problems; demonstrated interpersonal, verbal and written communication skills. 
  • Experience with a LIMS system preferable 
  • Ability to prioritize, manage multiple tasks, and meet deadlines. 
 

About Us:
  • Our company is an equal opportunity employer.
  • We are able to offer the opportunity to be part of 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.