Synergy Bioscience is a contract research organization (CRO) that serves pharmaceutical, biotechnology, and medical device companies with product development support and analytical chemistry and microbiology testing services. We are seeking a dynamic Microbiologist to join our team.

As a Microbiologist, your role will be central to the micro lab operations, requiring a keen eye for detail, a strong foundation in microbiology, and a commitment to excellence. Here’s what we’re looking for in our ideal candidate:

Key Responsibilities:

• Develop and execute microbiology testing methods, such as aseptic techniques, sterility testing, preservative effectiveness testing, growth promotion, visibility, and total aerobic count.
• Has clear understanding and good experience with Endotoxin USP <85>, Bioburden USP <61> and <62>, Anti-microbial Effectiveness testing USP <51>, Host cell DNA, qPCR, and JP 4.05 testing. 
• Initiate OOS whenever necessary, lead thorough investigations, adeptly manage Corrective and Preventive Actions (CAPAs), and keep all test procedures and standards up to date.
• Maintain our culture of quality by managing stock cultures, and biological indicators, and ensuring the high quality of microbiological media.
• Undertake sterility testing and microbiological research as directed. As well as interpreting data and providing insights that drive decision-making.
• Develop, validate, and verify microbiology testing methods, to ensure compliance with USP and other compendial relating to a range of microbiological assessments.
• Ensure all equipment is qualified, calibrated, and maintained to meet the stringent "Before-Use" standards.
• Adhere to GDP and GMP requirements, and develop documentation under management directives.
• Provide sound guidance to clients, when needed, with respect to microbiology process, product, and risk.
• Coach and mentor internal stakeholders as needed to foster a GMP-compliant site.
• Provide support as needed for clean-room qualification, re-qualification, and environmental monitoring.
• Keep the microbiology laboratory environment pristine and well-equipped, managing GMP supplies efficiently.
• Be proactive in regulatory affairs by initiating and participating in investigations, audits, and inquiries to maintain our high standards.

Essential Qualifications:

• Master's degree in Microbiology. Higher credentials are a plus. 
• A robust Microbiology background and a minimum of 5 years solid experience in Microbiology testing
• Good knowledge and experience in the USP, other compendial and FDA regulations as they relate to microbiology testing.
• Experience with qualifications of testing equipment and clean room qualifications.
• Proven expertise in conducting microbiological assays within a clean room setting and upholding its stringent standards.
• Exceptional skills in technical writing, with a particular focus on the creation of Standard Operating Procedures (SOPs) and protocol and technical report writing.

If you are interested and available to assume this role, please submit your resume. We will contact you if your resume is in line with the job requirements.