Enzene Inc., a leading Contract Development and Manufacturing Organization (CDMO) and subsidiary of Enzene Biosciences, is seeking a Quality Control Microbiology Scientist for its Hopewell, New Jersey facility.
With a strong operational presence in India and a growing footprint in the U.S., Enzene is dedicated to providing high-quality biologics manufacturing services, advancing the pharmaceutical industry with a focus on biosimilars.
Company Background
- Location: Hopewell, New Jersey, United States
- Parent Company: Enzene Biosciences (a subsidiary of Alkem Laboratories Ltd.)
- Focus: Biologics manufacturing and CDMO services
- Compliance: cGMP, USP, EP, and FDA standards
- Website: www.enzene.com
Job Details
| Field | Information |
|---|---|
| Job Title | Quality Control Microbiology Scientist |
| Location | United States, New Jersey, Hopewell |
| Type | Full-time |
| Salary Range | $56,000.00 – $72,000.00 per year |
| Application | Apply via www.enzene.com/careers (if available) |
Key Responsibilities
- Quality Testing: Perform routine and dynamic environmental monitoring for cleanroom processes. Conduct water and compressed gas utility sampling and testing. Execute growth promotion testing (GPT) on microbiological media, bioburden testing via membrane filtration, and 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 lab instruments (e.g., incubators, endotoxin readers, filtration units). Ensure equipment qualification and cGMP compliance; support troubleshooting and root cause investigations.
- Technology Transfer (TT) and Validation: Assist with method suitability protocols for media qualification, bioburden, and endotoxin methods under supervision.
- Troubleshooting: Support investigation and resolution of out-of-specification results, method failures, and equipment issues. Participate in deviation investigations, CAPAs, and change controls with technical input.
- Data Analysis and Reporting: Complete lab test forms, logs, and notebooks per good documentation practices. Collaborate with management for timely data release. Compile and interpret data to confirm quality standards or identify deviations. Familiarity with LIMS for data tracking is preferred.
- Collaboration: Work with senior staff on environmental monitoring, testing, and troubleshooting. Assist with method development and process optimization; provide feedback during procedural updates.
- Training: Participate in a structured program to develop technical proficiency, regulatory compliance, and lab best practices. Perform tasks under supervision, including environmental monitoring, bioburden, endotoxin, and GPT.
Job Requirements
- Education: Bachelor’s degree in Microbiology, Chemistry, Biochemistry, Biotechnology, or related field (advanced degrees preferred)
- Experience: 1–3 years in a cGMP Microbiology or Analytical laboratory
Skills:
- Knowledge of or exposure to environmental monitoring (air, surface, personnel sampling) and utility testing (water, gas)
- Willingness to learn aseptic gowning and work in cleanrooms
- Understanding of aseptic technique; hands-on BSC experience is a plus
- Familiarity with growth promotion testing, membrane filtration (bioburden/sterility), and BET (gel clot, chromogenic, turbidimetric)
- Knowledge of microbial identification (subculturing, gram staining)
- Proficiency in Microsoft Office; familiarity with LIMS or cGMP-compliant systems desirable
- Communication Skills: Strong verbal skills and developing technical writing ability
- Physical Demands: Involves sitting, standing, walking, typing, reaching, and close vision for computer work. Operates in an office setting with standard equipment (computers, phones, etc.). May require stooping, kneeling, or crouching.
Benefits
- Health Insurance: Medical, Dental, Vision
- Life and AD&D Insurance
- Disability Insurance: Long-term and Short-term
- 401k Retirement Plan
- Paid Time Off
- Career Growth: Training in cGMP, microbiology testing, and lab operations
Why This Role Matters
This role supports Enzene’s biologics manufacturing, enhancing Hopewell’s growing biopharma ecosystem with over 300 projected jobs. Your work ensures product safety and compliance with global standards.
Growth Opportunities
- Training in advanced microbiology techniques (e.g., BET, bioburden) and cGMP compliance.
- Potential advancement to senior scientist or supervisory roles.
Work Environment
- State-of-the-art lab and cleanroom facilities.
- Collaborative culture with a focus on innovation.
- Office-based with occasional physical tasks.
How to Apply
- Location: Hopewell, New Jersey, United States
- Application: Apply via www.enzene.com/careers or contact HR
- Requirements: Submit resume, educational certificates, and proof of experience.
Verified by Trusted HRs
The post is released by the Enzene LinkedIn page. Click here to visit the post
Preparation Tips:
- Highlight cGMP or microbiology lab experience.
- Demonstrate aseptic technique or equipment handling skills.
- Prepare for questions like “How do you ensure cGMP compliance?” or “What is your approach to BET?”
Important Disclaimer
- Enzene does not charge fees for applications or recruitment.
- Verify opportunities through official channels (e.g., website or HR).
- Report suspicious activities to HR.
Safety from Fraud
- Confirm offers through Enzene’s official website or HR.
- Avoid sharing personal/financial details with unverified sources.
- Contact HR for clarifications.
Why Hopewell, New Jersey?
- Part of the Northeast biopharma corridor with over 300 new jobs projected.
- Hosts Enzene’s advanced manufacturing and QC facilities.
- Ideal for microbiology careers with proximity to Princeton.
Join Enzene’s Mission
Enzene is committed to advancing biosimilar manufacturing and improving patient outcomes globally. Join our Hopewell team to contribute to this mission. Apply now to be part of our innovative workforce!
Next Steps
- Apply by 3:52 PM IST today via www.enzene.com/careers.
- Shortlisted candidates will be contacted for interviews.
- Successful candidates will receive further onboarding details.
Contact Us
- Website: www.enzene.com
- Email: Check career page for HR contact
Innovate with Enzene
Join Enzene to advance microbiology excellence in Hopewell. Apply today and drive innovation in healthcare!