Microbiology Scientist

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.

Reporting to the Microbiology Supervisor.

Job summary:

Perform routine evaluations of raw materials, finished products, components, stability, and special project test samples as directed by the supervisor. Perform development evaluation of new raw materials and finished products as directed and document results in scientific reports. Support the laboratory to ensure procedures, equipment, supplies, and inventory are available for routine testing, monitoring, and for qualification and implementation of new tests and equipment.

Support the qualification/validation of equipment and new processes.

• Sample Testing and Environmental Monitoring:
  Perform routine microbiological analyses and reporting of raw materials, components, finished products, stability samples, and sample requests.
• Perform environmental monitoring of purified water, water for injection, pure steam, compressed air, and non-sterile manufacturing operations.
• Handle and reconcile controlled substances.
• Participate in investigations.
• Perform Visual Inspection Testing.
• Perform Particulate Matter Testing.
• Handle Biological Indicators.
• Maintain Stock Cultures.
• Perform Microbial Identifications and apply further microbial assessment as needed.
• Perform sterility testing of sterile finished products.
• Perform bacterial endotoxin testing of raw materials and finished products.
• Support qualifications of new materials, products, and equipment. Document results in reports.
• Review/check data.

• Contribute to ensuring laboratory SOPs are documented, accurate, and up-to-date to industry and customer expectations.
• Provide continuous improvement support for established methods and processes.

• Support lab systems as assigned and maintain the laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, CDC/NIH and OSHA regulations.
• Maintain accurate and orderly records.

• Associate’s Degree in Life Sciences (Bachelor’s Degree in Microbiology or Life Sciences preferred).
• Minimum of three (3) years in an FDA regulated, directly relevant microbiological function preferred.

• Ability to read, communicate, and legibly write in English, analyze and interpret scientific and regulatory documents.
• Ability to apply and understand general mathematical concepts such as exponents, averages, and logarithms.
• Ability to apply principles of logical and scientific thinking to a wide range of practical and applied problems.
• Ability to work independently and in a team environment and take the initiative to learn new techniques.
• Effective planning, organization, and prioritizing of multiple work assignments and/or projects.
• Ability to quickly learn and demonstrate comprehension of cGMPs and SOPs.
• Must have excellent attention to detail and the ability to follow procedures and perform tasks with a high degree of accuracy and quality.
• Ability to identify potential issues before they impact manufacturing and packaging operations.
• Ability to analyze problems via the scientific method and draw data-supported conclusions.
• Demonstrable applied microbiological skills.

• Basic Outlook skills: sending messages, managing address books, scheduling, and task management.
• Intermediate Microsoft Word skills: creating basic letters and simple tables/charts; document creation, formatting, mail merge, and basic templates.
• Intermediate Excel skills: creating formulas, charts, data sorting/filtering, and basic data analysis tools (pivot…