Quality Control Microbiologist II
General Job Description:
We are seeking a Quality Control Microbiologist II to perform environmental monitoring of clean rooms and controlled areas to support manufacturing and routine sampling of the facility. Conduct microbial based assays including Bioburden testing, Endotoxin testing, Microbial quantification, and Organism identification. Frequently update management on environmental trends. Implement corrective action plans when necessary. Support the department by identifying or troubleshooting issues that may affect laboratory or facility monitoring or processes primarily in support of QC daily investigations, and other daily QC operations. Participate in release testing of Raw Material, In-Process samples, Purified Bulk, and Final Product.
Epeius’ mission is to pioneer innovative gene therapies for administration to cancer patients in order to improve patient survival and ultimately to make patients cancer free. Our approach to synergistically kill tumors while activating the immune system to fight the patient’s cancer combined with the integration of novel companion diagnostics, positions us on the cutting edge of cancer immunotherapies and emerging clinical stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and since we are currently small, every individual and each idea is important and counts.
Primary Duties and Responsibilities (include but are not limited to):
- Support and/or lead continuous improvement projects in the QC Micro Laboratory;
- Environmental monitoring and/or Personal monitoring of clean rooms and controlled areas;
- Participate in the generation of test plans, protocols, and reporting documentation monitoring the incubators, biosafety cabinets, etc.;
- Perform microbial and particulate monitoring of clean rooms and controlled areas;
- Testing to support microbial identifications, bioburden analysis, biological indicators, growth promotion, etc.;
- Read microbial plates and interpret test results. Some troubleshooting will be required;
- Perform change requests when required and complete them in a timely manner;
- Ensure laboratory area is maintained in a GMP state at all times while following all EHS and GMP guidelines;
- Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed;
- Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner;
- Will be crossed trained on Analytical testing methods and participate in release/stability testing as well as method qualification;
- Ensure personal training requirements are met and that training records are current.
- BS degree in Biology, Microbiology or related discipline with 3+ experience working in a Biotech or Pharmaceutical FDA regulated industry;
- General knowledge of FDA regulations, applications of current Good Manufacturing Practices (cGMP);
- Demonstrated ability to multi-task in a dynamic fast-paced cross-functional environment, with good quality and efficiency;
- Team player with excellent written and interpersonal communication skills;
- Able to work independently and with intermittent supervision;
- Eligible to work in the U.S.
NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.