Enzene - Microbiology Associate Scientist

1130 Works; Hopewell (NJ); On-site; USD 58,000 - 77,000; Full time

Job summary

A leading biotechnology company is looking for a Quality Control Microbiology Scientist to handle cGMP microbiological testing. The role requires specific knowledge of quality control standards, experience in a laboratory setting, and entails collaboration with senior scientists. This position offers a dynamic work environment with focus on innovation and integrity.

Qualifications

• 1 - 3 years of experience in cGMP Microbiology or Analytical laboratory.
• Understanding of cGMP and Quality Control in pharmaceuticals.

Responsibilities

• Execute routine and non-routine cGMP microbiological testing.
• Troubleshoot out-of-specification results and method failures.
• Collaborate with senior staff to support environmental monitoring.

Skills

Knowledge of environmental monitoring

Aseptic techniques

Communication Skills

Education

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

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 routine and dynamic environmental monitoring in support of cleanroom manufacturing processes. Perform water and compressed gas utility system sampling and testing as required. Perform growth promotion testing (GPT) on microbiological culture media. Conduct bioburden testing via membrane filtration. Execute bacterial endotoxin testing (BET) using gel clot, kinetic chromogenic, or turbidimetric LAL methods. Subculture and prepare microbial isolates for identification.

• 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: Under direct supervision, assist with the execution of method suitability protocols for media qualification, bioburden and endotoxin methods.

• 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: Accurately complete laboratory test forms, logs, and notebooks following good documentation practices. Work closely with management and senior staff to ensure timely release of microbiology testing data. 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.

• Collaboration: Collaborate with senior staff to support environmental monitoring activities. Work with senior scientists to perform testing and troubleshoot procedures. Assist senior staff with method development and process optimizations. Provide feedback during procedural updates or test verification.

• Training: Undergo a structured training program designed to develop technical proficiency, regulatory compliance awareness, and laboratory best practices. Observe and perform tasks under direct supervision including environmental monitoring, bioburden, endotoxin and growth promotion testing, and sample receipt.

Qualifications

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

• Experience: 1 - 3 years of experience in a cGMP Microbiology or Analytical laboratory. The successful applicant should possess an understanding of cGMP and Quality Control in a pharmaceutical space.

• Skills: Knowledge of or exposure to environmental monitoring activities such as air (active/passive), surface, and personnel sampling, including awareness of water and gas utility testing, is beneficial. Willingness and ability to learn full aseptic gowning procedures and operate within a cleanroom setting. Understanding of aseptic technique; hands-on experience within a Biological Safety Cabinet (BSC) performing aseptic manipulations is a plus. Familiarity with or exposure to growth promotion testing for microbiological media is preferred. Understanding of membrane filtration methods used for bioburden or sterility testing. Knowledge of Bacterial Endotoxin Testing (BET) principles for gel clot, chromogenic, or turbidimetric methods. Understanding of microbial identification techniques such as aseptic subculturing, gram staining, or isolation of colonies is preferred. Familiarity with Microsoft Office applications and an understanding of electronic documentation or laboratory systems (e.g., LIMS, cGMP-compliant tools) is desirable.

• Communication Skills: Strong verbal communication and a developing ability in technical writing are preferred.

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.