Synergy Bioscience is a Contract Research Organization (CRO) serving pharmaceutical, biotechnology, and medical device companies with product development support and analytical chemistry and microbiology testing services. Currently, we are seeking a dynamic Senior Microbiologist to join our full-time staff.

As a Senior Microbiologist, your role will be central to our 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:

Essential Qualifications:

• A bachelor’s degree in microbiology.
• A robust career background with a minimum of 7 years in Microbiology testing.
• Good knowledge and experience in 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 protocols.

Key Responsibilities:

• Develop and execute microbiology testing methods, interpret data, and provide insights that drive decision-making.
• Lead thorough investigations, adeptly manage Corrective and Preventive Actions (CAPAs), and keep all test procedures and standards up to date.
• Handle the regular laboratory tasks, such as sample logging, testing, trend analysis, environmental monitoring, and more.
• Maintain our culture of quality by managing stock cultures, and biological indicators, and ensuring the high quality of microbiological media.
• Undertake sterilization testing and microbiological research as directed.
• Develop and refine microbiology testing methods, ensuring compliance with USP/EP chapters relating to a range of microbiological assessments.
• Ensure all equipment is qualified, calibrated, and maintained to meet the stringent "Before-Use" standards.
• Adhere to Good Documentation Practices and prepare GMP 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 in order to foster a GMP-compliant site.
• Provide support as needed for cleanroom qualification, requalification, 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.

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.