Proclinical is currently recruiting for a Microbiologist with a pharmaceutical company located in Richmond, VA.
- 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.
- Proactively identify new Innovation capabilities to support new microbiological claims and visualization.
- 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.
Skills and Requirements:
- Minimum, Bachelor of Science degree in Microbiology, Industrial microbiology, Knowledge of Antimicrobials & preservatives
- Preferred , MSc or PhD 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 product development process 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
If you are having difficulty in applying or if you have any questions, please contact Jarred Fetterman at 215-531-5593.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.