Microbiologist

Company Overview:

Synergy Bioscience is a CRO supporting pharmaceutical and medical device companies with their product development and testing services. We are committed to fostering a culture of innovation, inclusivity, and patient-centricity, making Synergy an ideal platform for ambitious individuals to make a significant impact on global health.

Position: Microbiologist (Full-Time) Location: Dallas, Texas

Qualifications:

• A Bachelor's degree in Microbiology.
• At least 5 years experience in Pharmaceutical Microbiology testing.

Essential Skills and Experience:

• Robust background in microbiology with hands-on experience in product testing.
• Demonstrable technical writing skills, particularly in creating SOPs and protocols.

Preferred Skills and Experience:

• Prior experience within the pharmaceutical/biotech industries.
• Familiarity with environmental monitoring and sterility testing.

Primary Responsibilities:

Microbiological Analysis:

• Perform sample analysis, interpret data, and provide meaningful results.
• Lead investigations and manage Corrective and Preventive Actions (CAPAs).
• Review and update Test Procedures/Standard Operating Procedures.
• Undertake other related laboratory tasks.

Specific Microbiological Duties:

• Receive, verify, and log in samples.
• Conduct sample testing, and compile, and analyze trend data.
• Perform environmental monitoring, bioburden testing, and water sampling.
• Manage stock cultures, biological indicators, and microbiological media, ensuring quality control.
• Carry out sterilization activities.
• Conduct research experiments as directed by management.
• Develop, validate, and qualify methods.
• Execute tests as per USP chapters <51>, <55>, <61>, <62>, <71>, and <85> pertaining to antimicrobial effectiveness, biological indicator resistance, microbial enumeration, specified organism testing, sterility, and bacterial endotoxins.

Calibration Duties:

• Perform "Before-Use" calibrations prior to testing.
• Review calibration data and complete calibration/preventive maintenance paperwork.

GMP Compliance:

• Prepare GMP documentation as required by management.
• Maintain a clean and sterile laboratory workspace and equipment.
• Purchase and manage GMP supplies.

Investigation and Auditing:

• Initiate, facilitate, and perform investigations and Notices of Events (NOEs) for environmental samples.
• Inform management about non-conforming events.
• Participate in regulatory, in-house, and corporate audits.
• Conduct self-inspections and safety inspections.
• Retrieve data as requested by Microbiology management.