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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 the Kelsey McNaboe,

JOB SUMMARY:

With limited supervision, develops, qualifies, and troubleshoots microbiological analysis for stability, finish 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.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Manufacturing Operational Support

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.

Methods for New Products & Product Transfers

Functions as Microbiology representative and SME on project teams, as needed.

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.

Method Development and Optimization

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.

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.

Maintains instruments and equipment. Coordinate the validation and calibration of laboratory instrumentation.

Laboratory SME Support

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.

Your profile

+ 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 desired.

Computer Skills:

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.

SCOPE OF DECISION-MAKING: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.

LEVEL OF SUPERVISION PROVIDED:Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.

INTERNAL / EXTERNAL CONTACTS:Regular inside and outside the organization: Requires regular contact with laboratory personnel and/or other departments, with occasional contacts with individuals outside the organization. Also includes jobs with regular customer/client contacts.

PHYSICAL REQUIREMENTS/ENVIRONMENT:

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.

WORKING CONDITIONS:

Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.

Occasionally subjected to weekends, holidays, and irregular hours. Hours are predominantly weekday, first (A) shift, eight (8) hour days.

Compensation range

82,000.00 - 88,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

A Smarter Total Compensation Package

At Unither, your base salary is just the beginning. Our Total Rewards include:

+ 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

+ And more—because we invest in your health, your future, and your peace of mind.

It’s a package designed to reward impact—not just hours worked.

More Than Just a Paycheck

At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums.That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!