江苏省-无锡市-惠山区 | 若干人
The role will provide microbiology testing, knowledge and expertise to support the delivery of new products, product development, innovations, methods, and technology development programs.
Key Responsibilities
• Successfully manage projects by providing technical input to project teams on microbiological aspects throughout the project lifecycle, ensuring Microbiology Quality by Design principles and relevant regulatory requirements are built into project plans. Maintains a good project overview and understanding of business priorities and foresees potential issues, working proactively to provide solutions.
• Ensure appropriate microbiology testing is embedded in project plans and all results are delivered on time with all routine and non-routine Microbiological work performed following good scientific practice or GMP and in accordance with written procedures.
• Technically proficient as a microbiologist with evidence of ability to conduct a broad range of simple and complex microbiological research and/or testing. Drive to become a SME in Microbiology and associated research methodology, with an enthusiasm to maintain and expand knowledge alongside advancements in industry and the wider scientific field.
• Develops test plans with Design of Experiments (DoE) principles to generate robust data package for new projects.
• Maintain adherence to documented procedures for all aspects of laboratory work, ensuring that all relevant information concerning samples is recorded, that samples are handled correctly, and that all necessary records and quality data are maintained.
• Reviews internal and external microbiology data for projects, highlighting issues/alerts/outages along with appropriate action needed. Carry out root cause analysis and implement effective CAPA.
• Ensure adherence of Quality and EHS practices and provide support for the internal and external audits and inspections.
Required Qualifications:
• Bachelor of Science degree in Microbiology
• Specific knowledge of any of the following: Microbiology, Industrial microbiology, Oral Microbiology, Biofilms, Knowledge of Antimicrobials & preservatives
Required Skills & Experience:
• Experience of working in a Microbiology laboratory, where independent design of experiments, testing and research are required
• A knowledge of product development process and Microbiology requirements within Quality and compliance framework would be an advantage
• Strong communication, influencing and negotiations skills using Technical expertise. Ability to facilitate alignment and collaboration across functions.