Microbiology Scientist III

Overview

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. 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 the Kelsey McNaboe, this role involves microbiology and aseptic processing in relation to compendial guidelines for internal and external customers. With limited supervision, you will develop, qualify, and troubleshoot microbiological analysis for stability, finish product and raw material release, and development testing. You will serve as a subject matter expert (SME) of microbiology and aseptic processing and 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 technical expertise for corrective/preventive measures and align processes to consistently manufacture quality products. Support customer and government regulatory site inspections. Serve as an SME in the environmental assessment program for a cGMP manufacturing facility. Function as Microbiology representative and SME on project teams.
• Methods for New Products & Product Transfers – Act as Microbiology representative and SME on project teams as needed. Provide consultation regarding new test methods and method updates. Produce scientifically sound, clearly written microbiology protocols and reports. Conduct and assist in the transfer of methods to customers and identified contract lab organizations (CLOs).
• 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 (e.g., PhrEU and USP monograph changes) and implement for commercialization. Participate in process change activities and lead improvements to refine systems and improve efficiencies.
• Completed Analyses – Perform routine analysis of raw materials, intermediates, components, finished products, stability pulls and special test requests following CGMPs. Write, execute, and review experimental lab protocols and reports. Review and approve laboratory data. Maintain instruments and coordinate validation and calibration of laboratory instrumentation.
• Laboratory SME Support – Transfer qualified equipment and methodology to staff through hands-on training. Develop and provide technical training for Microbiologists and Lab Assistants. Identify and track microorganisms recovered from QC evaluations, environmental monitoring, and other sources. Lead and write laboratory investigations with cross-department collaboration. Distinguish training needs and work with supervisors to address performance issues. Provide mentorship and write/review laboratory procedures.

• EDUCATION & EXPERIENCE:
  
  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 desirable.

Computer Skills: Ability to read, communicate, and legibly write in English; analyze and interpret scientific and regulatory documents. Demonstrable comprehension of cGMPs and related regulatory/compliance programs. Ability to identify potential issues before they impact manufacturing and packaging operations. Ability to analyze problems via the scientific method with data-supported conclusions. Microbiological expertise and aseptic technique. Proficiency in Microsoft Office (Word, Excel, PowerPoint) with advanced skills for docs, formulas, charts, and data analysis as applicable.

• Compensation Range – 82,000. USD
• Total Compensation – Includes benefits such as 100% employer-paid medical premiums, 401(k) with 6% match plus 4% company-funded contribution, HSA contributions, and wellness incentives.
• Work Environment – Normal office with occasional controlled environment work; biosafety Level 2 laboratory. Occasional travel and weekend/irregular hours; standard first shift hours, eight-hour days.

Join us to contribute to a culture built on Respect, Responsibility, Trust, Courage and Innovation. We are committed to autonomy and ongoing development for our employees.