Senior Associate II, Microbiology

How you’ll make an impact:

As a self-starter and highly motivated experienced professional, you will oversee rapid microbial testing for the company’s new internal clinical manufacturing facility. You will be responsible for overseeing contract lab testing and supporting safety testing for novel drug products targeting oncological indications and providing oversight for the testing of release, stability, and routine environmental monitoring samples via contractors. 

You will play a key role in training and overseeing internal environmental monitoring once brought in-house. Combining your experience in supporting validating and implementing rapid microbial methods with the support of clinical candidates, you will serve as the subject matter expert for environmental monitoring issues to provide technical expertise aligned with current GMPs. 

About the team:

The 270-MPH Testing team is a growing and vital group that supports release and stability testing of our early phase oncology products manufactured in our clinical manufacturing facility. An integrated partner of Clinical Manufacturing and Quality, we are driven by our commitment to give time back to our patients. Come work with an incredibly talented group of employees that loves rising to the challenge much as we do defeating cancer!  

How you’ll spend your time:

• Serve as subject matter expert for environmental monitoring issues 
• Manage contract testing laboratory for microbial testing of in-process and final product  
• Oversee sample collection, shipment, receiving and reviewing test data, and deliver the results internally 
• Oversee environmental monitoring contractors for manufacturing suites. Ensure samples are collected at determined frequency, receive results of sampling and deliver results internally 
• Serve as subject matter expert for environmental monitoring issues 

• Support establishment of rapid microbial method testing for lot release of drug product to support internal clinical manufacturing 
• Support set up, manage, and maintain the Environmental Monitoring program for an internal manufacturing site  
• Support all aspects for microbial testing, from sample receipt and chain of custody through generation of CoTs 
• Provide expertise to support investigations, deviations and CAPAs  
• Promote internal, cross-functional communication 

• Implement process improvements to support operational efficiencies  
• Promote a culture of Quality and Operational excellence 

Who you are and what you’ve accomplished:

• BA or BS in Biology, 5+ industry experience within the biopharmaceutical/cell and gene therapy industry with experience in aseptic processing, microbial testing and environmental monitoring required, experience in site start-up operations is a plus  
• Experience leading activities in microbiology laboratories that support sterile manufacturing  

• Understanding of cGMP/ICH/FDA/EU guidance and regulations relating to safety testing of biologics or cell and gene therapies 
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders (internal and external) 
• Demonstrated leadership within teams producing results 
• Ability to communicate above and below level in a way that fosters positive relationship building 
• A passion for addressing the critical unmet medical needs of patients 

• Self-directed individual who can work in a risk tolerant, fast-paced, innovative environment