About Nucleus Biologics
At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.
Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.
About the role
The QC Microbiologist will be responsible for performing microbiological testing and analysis to ensure the quality and safety of our products. The ideal candidate will have a strong background in microbiology, aseptic techniques, and regulatory compliance, with a commitment to maintaining high standards of quality and accuracy.
What you'll do:
Quality Control Testing
- Perform routine microbiological testing, including but not limited to:
- Microbial enumeration (bioburden, total viable count)
- Sterility testing
- Endotoxin testing (LAL)
- Environmental monitoring (air, surface, and water sampling)
- Identification of microorganisms (e.g., Gram staining, biochemical tests, MALDI-TOF)
- Conduct testing of raw materials, in-process samples, and finished products to ensure compliance with specifications and regulatory standards.
- Maintain and operate laboratory equipment, including autoclaves, incubators, and microscopes.
- Prepare and review standard operating procedures (SOPs), test methods, and protocols.
- Investigate and document deviations, out-of-specification (OOS) results, and non-conformances.
- Support validation and qualification activities for microbiological methods and equipment.
- Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements.
- Participate in internal and external audits as needed.
- Maintain accurate and detailed records of all testing and analysis.
- Collaborate with cross-functional teams to resolve quality issues and improve processes.
- Stay updated on industry trends, regulatory changes, and advancements in microbiological testing techniques.
Stability Program Management
- Oversee the stability program, including the onboarding of new stability studies, generating stability protocols, scheduling testing, reviewing results, and finalizing reports.
- Ensure compliance with stability study protocols and regulatory requirements.
- Collaborate with internal teams and external partners to ensure stability program objectives are met.
Environmental Monitoring & Water Testing Oversight
- Ensure the timely completion of Environmental Monitoring (EM) and high-purity water testing.
- Review and analyze testing data, identifying trends and areas for improvement.
- Prepare and present quarterly reports summarizing EM and water testing performance.
Qualifications:
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related field preferred; a combination of education and additional experience may be acceptable.
- Minimum of 2 years of experience in a quality control and/or microbiologist role within the pharmaceutical, biotechnology, or medical device industry.
- Strong knowledge of GMP, ISO, and regulatory requirements related to microbiology USP methods (60, 61, 62, 71), stability programs, and environmental monitoring.
- Experience with quality management systems (QMS) and electronic documentation platforms.
- Experience with Rapid Bioburden and/or Rapid Sterility methods is a plus.
- Excellent problem-solving, analytical, and organizational skills.
- Strong communication and leadership abilities, with experience managing cross-functional teams.
- Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships.
- Strong attention to detail
- Ability to exercise independent judgment consistent with Company guidelines.
Additional Skills
- Ability to independently develop and manage projects and timelines
- Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships
- Strong attention to detail and process mindset
- Ability to exercise independent judgment consistent with Company guidelines
- Excellent verbal and written communication skills.
- Familiar with statistical process control methods.
Physical Requirements
- Ability to hear and speak to employees and external associates on the phone and in person.
- Ability to see the letters and numbers on a personal computer screen and memos, reports, and other documents (near vision)
- Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego-based positions
Travel Requirements
- May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.
NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential functions. Management retains the right to add to or change the duties of the position at any time.
