Senior QC Microbiology Scientist - GMP & Aseptic Expert

Zenith LifeScience; Westborough (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Zenith LifeScience is seeking a Scientist II QC Microbiology to act as a senior technical subject matter expert, overseeing microbiological testing programs within GMP operations. The role provides technical leadership across QC Microbiology and Manufacturing, mentoring staff and delivering aseptic technique training to ensure contamination control and regulatory compliance.

Responsibilities include leading environmental monitoring, sterility, endotoxin, and mycoplasma programs; reviewing data

Qualifications

• Requires a BS or MS in Biology/Microbiology with GMP QC microbiology experience.
• Demonstrated expertise in environmental monitoring, bioburden, endotoxin, sterility, mycoplasma and microbial identification intended.
• Experience mentoring laboratory staff and delivering technical training.

Responsibilities

• Serve as subject matter expert for microbiological testing programs including environmental monitoring, sterility, endotoxin, mycoplasma, microbial identification, and contamination control.
• Support QC Microbiology Senior Manager in oversight of laboratory operations, technical initiatives, and microbiological program execution.
• Develop and deliver aseptic technique and contamination control training for manufacturing and QC personnel to maintain GMP compliance.
• Track and support quality system activities including deviations, investigations, CAPAs, Change Control and trending for QC microbiology operations.
• Review and approve microbiological data, protocols, quarterly reports, SOPs and other technical documentation.
• Lead data trending and interpretation of environmental monitoring and microbiological data to identify risks and support contamination control strategy.
• Provide technical leadership and mentorship to microbiologists and junior scientists within QC microbiology laboratory.
• Author and review SOPs, protocols, validation reports, investigation reports and technical documents per GMP requirements.
• Lead or support method qualification, validation, and technology implementation for microbiological assays.
• Collaborate cross-functionally with Manufacturing, QA, Facilities and other teams to support manufacturing operations and process improvements.
• Support regulatory inspections, audits and responses by providing technical justification and documentation.

Skills

Advanced microbiology testing

Mentoring and training

cGMP knowledge

Technical writing

Cross-functional collaboration

Education

BS in Biology/Microbiology

MS in Biology/Microbiology or related

Job description

Zenith LifeScience is seeking a Scientist II QC Microbiology to act as a senior technical subject matter expert, overseeing microbiological testing programs within GMP operations. The role provides technical leadership across QC Microbiology and Manufacturing, mentoring staff and delivering aseptic technique training to ensure contamination control and regulatory compliance.

Responsibilities include leading environmental monitoring, sterility, endotoxin, and mycoplasma programs; reviewing data