Microbiology Scientist I

Microbiology Scientist I

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 280 employees.

Your role

Reporting to the Kelsey McNaboe,

JOB SUMMARY:
Perform routine evaluations of raw materials, finished products, components, stability, and special project test samples as directed by supervisor. Perform development evaluation of new raw materials and finished products as directed and document results in scientific reports. Supports laboratory to ensure laboratory 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.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
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.
Laboratory Environment Maintained to GMP Standards
Contribute to ensuring laboratory Standard Operating Procedures (SOPs) are documented, accurate, and up-to-date to industry and customer expectations.
Provide continuous improvement support for established methods and processes.

Safe, Compliant, Efficient Labs
Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, CDC/NIH and OSHA regulations.
Maintains accurate and orderly records

Your profile

EDUCATION & EXPERIENCE:
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.

KNOWLEDGE SKILLS & ABILITIES:
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 cGMP’s and SOP’s.
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.

COMPUTER SKILLS:
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.
Intermediate 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.
Intermediate 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.)
Basic 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 basic/routine analytical judgement. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

LEVEL OF SUPERVISION REQUIRED: Individual contributor, not responsible for the work of others.

INTERNAL / EXTERNAL CONTACTS: Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters or contact within other departments. Occasionally contacts individuals outside the organization. Contacts are primarily for the purpose of supplying or seeking information.

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 – 50% of the day, sitting – 20% of the day, and walking/moving about – 30% of the day.
Occasional lifting of up to 40 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

62,400.00 - 68,640.00 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.

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!