QC Microbiology Lab Associate (Aseptic Mftg/Environmental Monitoring) – Direct/Raleigh

Job Type: 
Professional Services
Other Professional Positions
Employment Category: 
Direct Hire

Our client, a North Raleigh-based biotech that is developing a portfolio of life-saving therapies based on its patented gene editing technology, is actively recruiting for a very sharp candidate to join its Microbiology team. 

The company is in the process of building out its primary production facility and this QC Lab Associate will be critically involved in developing and implementing its environmental monitoring program and other microbiological QC testing. Company will pay generously to attract and retain a star.

Key things to note:

  • The QC Microbiology Laboratory Associate will support GMP aseptic manufacturing operations as part of the Quality team. While gene therapy experience is desirable, company is also open to those coming from biologics/cell therapy settings. Aseptic mftg is a must.
  • Position will involve partnering with the QC Microbiology Supervisor to develop the QC Microbiology policies and practices – “from scratch.”  Ability to set up the lab, with no roadmap, will be essential.
  • The focus of the role will be environmental monitoring.  Significant relevant experience will be important.
  • This is a start-up setting and similar experience is preferred.  Right candidate will demonstrate the knowledge, initiative, resourcefulness and solutions-orientation needed to thrive in a building environment.

This QC Lab Associate will be responsible for helping to develop, qualify and execute the environmental monitoring program and other microbiological QC tests as well as related investigations, trend analysis and training.

Specifics include:

  • Perform environmental monitoring of GMP manufacturing rooms and isolators and utilities to meet FDA and EudraLex requirement
  • Assist in facility and laboratory qualification and validation activities
  • Growth promotion and qualification of incoming media
  • Perform environmental monitoring investigations, data entry, and trending analyses
  • Author, revise, and train on SOPs, protocols
  • Develop and lead training of site personnel on gowning practices
  • Serve as expert of aseptic techniques
  • Review data to ensure adherence to standard operating procedures and cGMP.
  • Laboratory sample receipt and tracking

Targeted candidate will offer a related scientific degree and 3+ years of hands-on environmental monitoring or microbiology laboratory experience in a biopharmaceutical company.  Substantial experience with Aseptic technique expertise is required.

Other priorities include:

  • Quality experience related to gene, cell therapy and/or biologic manufacturing
  • Familiarity with Microbiology Lab/Environmental Monitoring techniques and/or tools including sterility testing, endotoxin testing, BACT/ALERT, VITEK2,  biotek plate readers, etc.
  • Basic understanding of cGMP compliance.
  • Experience writing Standard Operating Procedures and Work Instructions
  • Longevity and impact in previous roles

Finally, we seek a highly collaborative and industrious professional who will thrive in this emerging and dynamic setting.  A lot is happening.  We seek an energetic, focused and flexible team player who will contribute broadly.

This is an immediate need and a Direct Hire opportunity.  Please forward Word resume for prompt consideration.

Local candidates only.