Microbiology Associate Scientist

Unither Pharmaceuticals is a French pharmaceutical industrial group focused on making accessible healthcare solutions, including sterile single-dose products. The Microbiology Associate Scientist performs microbiological analyses and environmental monitoring to support manufacturing and packaging operations, while maintaining laboratory procedures, equipment, supplies, inventory, and compliance with cGMP requirements.

Responsibilities

• Perform routine microbiological analyses and reporting of raw materials, components, sample requests and finished products, including but not limited to Microbial Limits
• Perform environmental monitoring of purified water, water for injections, clean steam, compressed air and non-sterile manufacturing operations
• Perform duties that support the laboratory function such as media preparation, housekeeping, and use of autoclaves
• Perform environmental sampling in advanced aseptic areas. Ability to aseptically gown required
• Ability to work aseptically in a lab setting as well as aseptic processing area
• Actively participates in job training
• Prepares media, reagents, and diluents
• Provides support for start-up functions, including but not limited to, balance checks, temperature checks, calibration checks, and remediation of biological wastes
• Performs laboratory glassware washing
• Autoclaves utensils, reagents, media, diluents and test equipment Performs laboratory file maintenance
• Monitors equipment certification/calibration schedules and schedules associated calibration/certifications
• Maintains supply inventory through ordering, receipt and rotation of supplies
• Performs inventory
• Supports lab systems assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, CDC/NIH and OSHA regulations

Preferred

• Associates degree in Biology or related field preferred
• Associates degree in Biology

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility

Company

• Sterile and non-sterile liquid pharmaceutical CDMO
• Paris, Ile-de-France, FRA
• https://www.unither-pharma.com/
• Founded in 1993
• 1001-5000 employees

Qualifications

• High School Diploma/GED required
• Minimum 1-year prior cGMP or regulated environment experience (including internships/ co-ops) required
• 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 prioritization of multiple work assignments and/or projects
• 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 quickly learn and demonstrate comprehension of cGMP's and SOP's
• Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks
• Basic Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files
• Basic Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data
• Associates degree in Biology or related field preferred
• Minimum 1-year prior cGMP or regulated environment experience (including internships/ co-ops) required.

Required skills

• Aseptic Technique, Autoclave Operation, CGMP Compliance, Environmental Monitoring, Laboratory Equipment Calibration, Media Preparation, Microbial Limits Testing, Microbiological Analysis, Standard Operating Procedures (SOPs)

Preferred skills

• Associates degree in Biology or related field preferred

Experience

• 1+ years