Microbiology Scientist III

Microbiology Scientist III

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees.

Your role

Reporting to Kelsey Mc Naboe ,

With limited supervision, develops, qualifies, and troubleshoots microbiological analysis for stability, finished product and raw material release, and development testing. Serves as a subject‑matter expert (SME) of microbiology and aseptic processing in relation to compendial guidelines for internal and external customers. Mentor and train laboratory personnel.

Manufacturing Operational Support

• Collaborate with other departments on investigations to determine root cause and assist in assessing product impact.
• Provide assistance to identify corrective/preventative measures necessary for observations made for improvement and to align processes to consistently manufacture quality products.
• Able to provide technical expertise for customer and government regulatory agency site inspections.
• Serve as an SME in the environmental assessment program for cGMP manufacturing facility.
• Function as Microbiology representative and SME on project teams.

Methods for New Products & Product Transfers

• Function as Microbiology representative and SME on project teams, as needed.
• Provide consultation regarding new test methods and method updates as required.
• Provide scientifically sound, clearly written microbiology protocols and reports.
• Conduct and assist in the transfer of methods to customers and identified contract lab organizations (CLOs), as needed.

Method Development and Optimization

• Investigate and justify approaches for cost improvements and operational efficiencies.
• Design experiments to qualify new technologies and methodologies for commercial implementation.
• Evaluate regulatory changes to existing methods and implement for commercialization.
• Proactively participate in activities in support of process changes, suggesting and leading process improvements to refine current systems and improve efficiencies.

Completed Analyses

• Be able to perform routine analysis of raw materials, intermediates, components, finished products, stability pulls and special test requests following CGMPs and established methods, as needed.
• Write, execute, and review experimental lab protocols and reports.
• Assist in reviewing and approving laboratory data.
• Maintain instruments and equipment; coordinate the validation and calibration of laboratory instrumentation.

Laboratory SME Support

• Transfer qualified equipment and methodology to requisite staff through hands‑on and informational training.
• Develop and provide technical training for Microbiologists and Lab Assistants to enhance understanding of microbiological concepts.
• Identify and track microorganisms recovered from routine QC evaluations, environmental monitoring, and other sources via in‑house equipment, classic techniques and outside reference laboratories.
• Lead and write laboratory investigations with collaboration from other departments as needed.
• Distinguish between training and non‑training needs and work with Supervisor/Manager to recommend appropriate solutions to performance problems.
• Provide mentorship to laboratory staff and be responsible for writing and reviewing laboratory procedures.

• Bachelor’s degree required.
• Minimum of ten (10) years in an FDA regulated microbiological function, preferably within a pharmaceutical/medical device release or support laboratory.
• Experience in aseptic processing, bacterial endotoxin testing, preservative efficacy, microbial identification, and sterility highly desired.
• Experience in design of experiments, method validation, and production environments…