Unither Pharmaceuticals · 2 weeks ago
Microbiology Scientist III
Rochester, NY
Full-time
Onsite
Senior Level, Lead/Staff
$82K/yr - $88K/yr
10+ years expUnither Pharmaceuticals is a French pharmaceutical industrial group focused on affordable healthcare products. The Microbiology Scientist III will develop, qualify, and troubleshoot microbiological analysis for product release and stability testing, serving as a subject matter expert in microbiology and aseptic processing.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Collaborate with other departments on investigations to determine root cause
Assist in assessing product impact
Provides 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
Serves as a SME in the environmental assessment program for cGMP manufacturing facility
Functions as Microbiology representative and SME on project teams
Provides consultation regarding new test methods and method updates as required
Provides scientifically sound, clearly written microbiology protocols and reports
Conducts and assists in the transfer of methods to customers and identified contract lab organizations (CLOs), as needed
Investigates and justifies approaches for cost improvements and operational efficiencies
Designs experiments to qualify new technologies and methodologies for commercial implementation
Evaluates regulatory changes to existing methods: i,e PhrEU and USP monograph changes and implements for commercialization
Proactively participates in activities in support of process changes
Suggests and leads process improvements to refine current systems and improve efficiencies
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
Maintains instruments and equipment
Coordinate the validation and calibration of laboratory instrumentation
Transfers qualified equipment and methodology to requisite staff through hands-on and informational training
Develops and provides technical training for Microbiologists and Lab Assistants to enhance understanding of microbiological concepts
Identifies 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
Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems
Provide mentorship to laboratory staff
Responsible for writing and reviewing laboratory procedures
Qualification
Required
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 desired
Ability to read, communicate, and legibly write in English, analyze and interpret scientific and regulatory documents
Demonstrable comprehension of cGMP's and associated regulatory/compliance programs
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 and aseptic technique
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
Advanced 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; create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes; as well as create and protect forms, use graphics, outline and organize long documents, create cross references, captions and bookmarks; use master documents to manage long documents, and create and use document templates
Advanced 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, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts; as well as the ability to enter and edit complex formulas, filter lists, sort ranges, create and run macros, and use data analysis tools (pivot tables, scenarios, etc.)
Intermediate PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art; as well as use and print notes, changing color schemes, changing fonts, bullets, slide backgrounds; adding a table, changing a slide layout, adding a chart, creating organizational charts, and search & replace
Decisions require complex microbiological judgment
Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities and including their application to cases not routinely covered
Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies
Regular contact with laboratory personnel and/or other departments, with occasional contacts with individuals outside the organization
Occasional travel required for seminars, conferences, and training
Must demonstrate visual acuity, color recognition, finger dexterity
Work with chemicals, biological hazards, and equipment including but not limited to microscopes, balances, biosafety cabinets, laminar flow hoods, and air samplers
Frequent standing – 30% of the day, sitting – 40% of the day, and walking/moving about – 30% of the day
Occasional lifting of up to 35 pounds
Hearing at a level to enable one to hear normal conversation
Biosafety Level 2 Biological Laboratory
Preferred
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 desired
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
Company
Unither Pharmaceuticals
Unither Pharmaceuticals is a French manufacturer of dosage forms for pharmaceutical laboratories and generic products.
1001-5000 employees
H1B Sponsorship
Unither Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2022-10-26Private Equity
2017-03-08Private Equity
2016-11-18Acquired
Leadership Team
Constance Sellman
CFO & IT Director
Recent News
2025-12-08
Company data provided by crunchbase