Microbiologist II - Sterile

Initial Therapeutics, Inc.; Houston (TX); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a dedicated Microbiologist to ensure the sterility and quality of pharmaceutical and biotech products. In this role, you will operate independently, conducting essential testing and managing samples while adhering to strict regulatory compliance. Your expertise will contribute to continuous laboratory improvements and support special projects, making a significant impact on the quality of products. Join a forward-thinking team where your skills in microbiology and analytical decision-making will be valued, and help drive innovation in the industry.

Qualifications

• Master’s degree in Biology or Microbiology or Bachelor’s with 3+ years of experience.
• Experience in microbiology labs, especially in sterility and endotoxin testing.

Responsibilities

• Perform sterility and particulate testing to ensure product quality.
• Manage samples and participate in continuous improvement initiatives.

Skills

Microbiology Knowledge

Analytical Skills

Communication Skills

Teamwork and Collaboration

Attention to Detail

Education

Master’s Degree in Biology or Microbiology

Bachelor’s Degree with 3+ years of experience

Tools

Biological Safety Cabinets (BSC)

Microsoft Office

Job description

Job Details Description

Position Summary

The Microbiologist's duties include ensuring the sterility and quality of pharmaceutical and biotech products. Responsibilities involve performing sterility and particulate testing, managing samples, supporting special projects, and contributing to continuous laboratory improvements.

Essential Responsibilities

1. Operate independently, maintaining responsibility for tasks such as routine testing (Sterility, Endotoxin, Particulate Matter) with minimal supervision to ensure regulatory compliance.
2. Review schedules and develop plans to ensure timely sample collection and testing. Reconcile test samples post-incubation to confirm proper handling within required limits.
3. Maintain proper chain of custody for samples, managing aliquoting, storage, receipt, and shipping effectively.
4. Participate in clean lab operations, preventive actions, and continuous improvement initiatives to reduce costs and improve efficiency.
5. Perform maintenance, calibration, and troubleshooting of equipment to meet testing deadlines.
6. Troubleshoot and resolve technical issues related to laboratory procedures and cleanroom operations; notify management of calibration failures or repairs.
7. Adhere to company policies and SOPs, including ISO 17025, cGMP, cGLP, A2LA, and QC guidelines, ensuring accuracy and compliance.
8. Calculate, evaluate, and review data; communicate results clearly and draft/review SOPs for consistent lab process execution.
9. Stay current with technology, especially in microbiology, equipment troubleshooting, and taxonomy, maintaining familiarity with all relevant systems.
10. Participate in cross-technology training programs to gain comprehensive lab understanding.
11. Assist with special projects, offering expertise and innovative solutions for pharmaceutical and biotech clients.
12. Support training and onboarding of new team members for competency and compliance.
13. Communicate effectively across departments to ensure smooth workflows and alignment with company goals.

Qualifications

• Master’s degree in Biology, Microbiology, or related field, or Bachelor’s with 3+ years of relevant experience.
• Preferred experience with Biological Safety Cabinets (BSC) and clean room environments.
• Experience in microbiology labs (Q.C., pharmaceutical, biotech, or clinical), with expertise in sterility testing, endotoxin testing, microbial identification, and related functions.
• Strong microbiology knowledge and communication skills.
• Excellent analytical, decision-making, and interpersonal skills; high accountability and attention to detail.
• Teamwork and collaboration skills, with strong verbal and written communication.
• Physical dexterity and ability to work independently.
• Proficiency in reading and complying with policies and SOPs, including safety regulations.
• Intermediate skills in Microsoft Office applications.
• Ability to focus and complete tasks timely; adaptable to learning new skills.

Preferred Qualifications and Skills

• Master’s degree with 2+ years of relevant experience.
• Experience working in cGLP or cGMP regulated labs is a plus.

Certifications

• N/A

Equal Opportunity Employer: This employer complies with federal employment laws. For more information, review the 'Know Your Rights' notice from the Department of Labor.