• Successfully manage complex R&D projects, by ensuring Microbiology QbD principles and relevant regulatory requirements are built in project plan.
• Maintains a good project overview and understanding of business priorities, foresees potential issues and works proactively to provide solutions.
• Develops test plans with Design of Experiments (DoE) principles to generate robust data package for the new launch.
• Perform microbial testing such as AET, MLT, method validation and water activity to support internal customers and the stability program.
• Ensures all routine and non-routine Microbiological work are always performed following good scientific practice or GMP and in accordance with written procedures.
• Prepares in-depth risk assessment for the projects and provide Microbiology expert summary for regulatory submissions. Proactively identifies opportunity reduce testing or use of historical data via sound technical justification.
• Reviews microbiology control systems data for trend analysis, highlighting alerts/outages along with appropriate action needed. Carry out root cause analysis and implement effective CAPA.
• Understands business needs and to seek opportunities to make improvements both within the scope of the project and in the Microbiology department working practices.
• In collaboration with stakeholders in R&D and manufacturing, provide technical input to project teams on microbiological aspect throughout the project lifecycle.
• Guides junior microbiology members in method development, product and raw material assessments and effective project planning for 'on time' and 'right first time' project deliverable . Alerts Team leader and key stakeholders on Microbiology issues and project concerns.
Knowledge/ Education / Previous Experience:
• Minimum, Bachelor of Science degree in Microbiology, Industrial microbiology, Knowledge of Antimicrobials & preservatives
• Preferred , BS or MSc in Technical expertise in a specialized Microbiology discipline such as Biofilm, Microbiome, host-microbe interactions
• 3+ years Minimum Level of Job-Related Experience required
• Experience of working in the Microbiology laboratory, where independent design of experiments are required.
• Good knowledge of testing per compendial methods (USP, EP, etc.) and Microbiology requirements within Quality and compliance framework
• Strong communication, influencing and negotiations skills.
• Ability to Demonstrating proficiency in Microsoft Office Suite including Outlook, Word and Excel
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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