Enzene - Microbiology Scientist

1130 Works; Hopewell (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

1130 Works is seeking a Quality Control Microbiology Scientist to oversee cGMP microbiological testing, ensuring product safety and compliance with relevant regulatory standards. Ideal candidates will have a degree in a relevant field, experience in a laboratory, and strong analytical and communication skills. This role offers an opportunity to be part of a dedicated team focused on improving processes in the pharmaceutical industry.

Qualifications

• 2-5 years of experience in cGMP Microbiology or Analytical laboratory.
• Strong understanding of cGMP and Quality Control.
• Knowledge of ICH/FDA/EU compliance regulations.

Responsibilities

• Perform growth promotion, bioburden, and endotoxin testing.
• Analyze and document results to ensure compliance.
• Operate and maintain microbiology laboratory instruments.

Skills

Aseptic technique

Microbial identification techniques

Communication Skills

Education

Bachelor’s degree in Microbiology, Chemistry, Biochemistry, Biotechnology

Advanced degrees preferred

Tools

Laboratory Information Management Systems (LIMS)

Job description

About Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
We are seeking a Quality Control Microbiology Scientist to be responsible for executing and supporting routine and non-routine cGMP Microbiological testing including Growth Promotion testing, Bioburden testing, Endotoxin (LAL) testing, and Environmental Monitoring to ensure product safety and compliance with USP, EP, and FDA regulatory standards.

Key Responsibilities

• Quality Testing: Perform growth promotion testing (GPT) on microbiological culture media. Conduct bioburden testing via membrane filtration or pour plate methods in accordance with validated procedures and compendial requirements (USP <61>/<62>). Execute bacterial endotoxin testing (BET) using gel clot, kinetic chromogenic, or turbidimetric LAL methods. Perform routine and dynamic environmental monitoring in support of cleanroom manufacturing processes. Perform water and compressed gas utility system sampling and testing as required.

• Equipment: Operate and maintain microbiology laboratory instruments (e.g., incubators, endotoxin readers, filtration units). Ensure equipment is qualified and compliant with cGMP requirements; support equipment troubleshooting and root cause investigations.

• Technology Transfer (TT) and Validation: Execute method suitability protocols for media qualification, bioburden and endotoxin methods. Support technology transfers and method validation activities including execution.

• Troubleshooting: Assist with investigation and resolution out-of-specification results, method failures, and equipment malfunctions. Participate in and author deviation investigations, CAPAs, and change controls, providing technical input as required.

• Data Analysis and Reporting: Compile, interpret, and document data from testing processes to confirm compliance with established quality standards or identify deviations. Familiarity with LIMS for data tracking and management is preferred. Collaborate with Quality Assurance, Validation, and Manufacturing departments to support microbiology method implementation and product release. Author and revise standard operating procedures or test methods for implementation in the QC Microbiology department.

• Collaboration: Work with cross-functional project teams to integrate QC Microbiology results into project plans.

• Training: Mentor and train junior quality control staff.

Qualifications

• Education: A bachelor’s degree in relevant fields such as Microbiology, Chemistry, Biochemistry, Biotechnology or related discipline. Advanced degrees are often preferred.

• Experience: 2-5 years of experience in a cGMP Microbiology or Analytical laboratory. Strong understanding of cGMP and Quality Control in a pharmaceutical space. Knowledge of ICH/FDA/EU compliance regulations and USP/EP/JP monographs for microbiology. A proven track record in a senior role is preferred.

• Skills: Strong understanding of aseptic technique. Hands-on experience working within a Biological Safety Cabinet (BSC) performing aseptic manipulations. Hands-on experience in growth promotion testing and execution of method suitability protocols for microbiological assays. Proficiency in membrane filtration techniques for bioburden and/or sterility testing. Experience with Bacterial Endotoxin Testing (BET) using gel clot, chromogenic, or turbidimetric methods. Competency in microbial identification techniques including aseptic subculturing and isolation of microorganisms using standard microbiological practices. Familiarity with laboratory information systems (LIMS), electronic documentation systems, cGMP data recording systems, and Microsoft applications. Knowledge of environmental monitoring (active/passive air sampling, surface sampling, personnel monitoring) including water and compressed gas systems. Knowledge of disinfectant efficacy testing.

• Communication Skills: Strong verbal communication and technical writing skills. Ability to author and revise protocols, experiments, standard operating procedures, test methods, and validation reports.

Physical Demands

• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.

• This job operates in an office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets.

• This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.