Environmental Monitoring Specialist (Aseptic Manufacturing) – Raleigh Biotech/Top $$
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 Quality Control team.
The company is in the process of building out its primary production facility. This Environmental Monitoring Specialist will be actively involved in developing and implementing the environmental monitoring program in support of its GMP aseptic manufacturing operations.
This is a critical role and company will pay generously to attract and retain a star.
Key things to note:
- The EM Specialist will help develop, qualify and execute the environmental monitoring program as well as participate in related investigations, trend analyses and training. Gene therapy experience is desirable, but company will also consider those coming from biologics/cell therapy settings.
- The focus of the role will be environmental monitoring. Specific experience with isolators, compressed gasses, and other EM techniques in an aseptic GMP-compliance setting will be important.
- This is an ISO 5 cleanroom facility. Familiarity with related standards and protocols would be valuable.
- This is a start-up setting. This Specialist will partner with the QC Microbiology Supervisor to develop Environmental Monitoring policies and practices – “from scratch.” Seek knowledgeable and industrious candidate who will thrive in a building environment.
Specifics duties will 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 experience in a cGMP- compliant biopharmaceutical company. Substantial exposure to aseptic technique is required. ISO 5 cleanroom experience would be a plus.
Other priorities include:
- Quality Control experience related to gene, cell therapy and/or biologic manufacturing
- Extensive experience with Environmental Monitoring techniques and/or tools including isolators, compressed gasses, etc.
- Excellent juggling and organizational skills
- 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 quick study who will contribute readily and extensively.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration.
Local candidates only.