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.