QC Microbiologist

Job Summary

Mycoworks is seeking a talented QC Microbiologist to support the quality team at the manufacturing site and innovation site. This position is not a remote or hybrid role. The candidate will work cross-functionally with individuals from departments such as Manufacturing, Engineering, Process Engineering, FMR&D, and Supply Chain. 

The role will require the candidate to organize and manage the QC testing and procedures associated with microbiology, such as technology transfer of liquid and/or solid inoculum testing, lab management, test method implementation, environmental quality monitoring, and cleaning standard development.  The goal will be to ensure the compliance of the key quality parameters for the manufacturing of biomaterials- Fine Mycelium. 

Responsibilities: 

• Leading technical and method transfer from the research development scale to manufacturing quality 
• Supporting the company’s key technologies in ensuring incoming materials and in-process materials that meet the minimum standards of quality 
• Providing technical training to the functional team members on microbiological sampling and testing, media plating, enumeration, data reporting, etc. 
• Communicating with internal and external stakeholders through meetings and clearly written technical emails, reports, and presentations
• Leading SOP writing for lab operations, testing protocols, and test validation 
• Managing environmental monitoring programs and providing recommendations for quality improvement in critical processes or systems such as HVAC, compressed air, steam 
• Establish cleaning standards and reinforce best cleaning practices at manufacturing site and innovation site
• Providing support for process and method validation, and development of analytical methods
• Conducting thorough statistical data analysis for large data sets 
• Performing the investigations of any out-of-specification lab results and reporting the results to Quality management in a timely manner 
• Tracking and reporting quality system metrics related to testing, OOS investigations, and training in support of quality systems reporting to Quality management 
• Acting as a backup for QC microbiological testing of incoming and in-process materials 
• Overseeing and ensuring the safety of lab operations including microbiological safety on a daily basis 
• Overseeing the lab equipment calibration and performance to ensure the accuracy of test results 
• Promoting safe operating and working procedures and practices 
• Managing the cleanliness and orderliness of the lab to prevent cross-contamination 
• Participating in internal plant audits and supporting the cross-training in QC and operator areas of responsibility related to quality 

Qualifications:

• Minimum 2+ years’ experience as a microbiologist or similar in a laboratory environment in food, consumer products, biotechnology or similar industries 
• BS or MS in biological science or microbiology, biochemistry, fermentation, or a relevant field 
• Strong experience in leading a functional team (the ability to set goals, delegate work, and follow up results) 
• Prior fermentation experience with a bioreactor is a plus 
• Prior experience in designing and setting up or managing a new lab is a plus 
• Experience and comfortable working in the laboratory setting environment 
• Experience in establishing an environmental monitoring program 
• Must have experience in establishing cleaning standards 
• Must have experience in supporting CIP and manual cleaning validation 
• Familiarity with statistical-guided experimental design and analysis (e.g. DoE) is a plus
• Excellent interpersonal and communications skills 
• Ability to deliver clear, compelling, and effective technical presentations
• Capable of working individually and as a part of a team 
• Must be flexible in terms of working hours to meet the requirements of the position
• Comfortable with autonomy and a deliverable-oriented approach
• Good critical thinking and experimental design skills
• Good problem-solving skills
• Excellent working knowledge of data analysis, statistical methods, and data reporting
• Must be able to lead by example on adhering to all lab safety procedures
• Highly adaptable to the dynamics of a fast-paced manufacturing environment 

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