Microbiology Associate Scientist

Microbiology Associate 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.

Your role

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 supervisor. Perform environmental monitoring to support manufacturing and packaging operations using suitable instrumentation according to cGMP's. 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.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Sample Testing and Environmental Monitoring

Perform routine microbiological analyses and reporting of raw materials, components, stability, sample requests and finished products, including but not limited to Microbial Limits.

Perform environmental monitoring of purified water, water for injection, clean steam, compressed air and non-sterile manufacturing operations.

Perform duties that support the laboratory function such as media preparation, housekeeping, use of autoclaves.

Ability to aseptically gown required.

Ability to work aseptically in a lab setting as well as aseptic processing area.

Actively participates in job training.

Handle and reconcile controlled substances.

Participate in investigations.

Perform Visual Inspection.

Perform Particulate Matter Testing.

Handle Biological Indicators.

Maintain Stock Cultures.

Perform Microbial Identifications.

Laboratory Environment Maintained to GMP Standards

Prepares media, reagents, and diluents - as needed.

Provides support for start-up functions, including but not limited to, balance checks, temperature checks, calibration checks, and remediation of biological wastes - as needed.

Performs laboratory glassware washing - as needed.

Autoclaves utensils, reagents, media, diluents and test equipment - as needed.

Performs laboratory file maintenance.

Monitors equipment certification/calibration schedules and schedules associated calibration/certifications

Inventory Maintained at Appropriate Levels

Maintains supply inventory through ordering, receipt and rotation of supplies.

Performs inventory.

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.

Your profile

EDUCATION & EXPERIENCE:

High School Diploma/GED required; Associates degree in Biology or related field preferred

Minimum 1 year prior cGMP or regulated environment experience (including internships/ co-ops) required.

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 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.

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.

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.

SCOPE OF DECISION-MAKING: Decisions require some judgment. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.

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

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

PHYSICAL REQUIREMENTS/ENVIRONMENT:

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:

Biosafety Level 2 Biological Laboratory, aseptic processing areas, normal office environment and controlled environment work that will require removal of jewelry and cosmetics.

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

Compensation range

24.00 - 26.00 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.

Benefits

• 401K Plan: Unither Matches up to 6% on Employee Contributions each pay period.
• Retirement plan: Unither has a 4% Retirement Savings Plan contribution each year on prior year earnings.
• Performance bonus: Hourly employees recive this pay out Quarterly and Salaried employees recieve this Annually.
• 11 Paid Holidays per year
• Health Insurance: Benefit Premiums Paid 100% by Unither for EE, Spouse or Domestic Partner, and Children.
• Dental and Vision Insurance: Offered for Employee, Spouse or Domestic Partner, and children.
• Health Savings Account (HSA): Quarterly Contributions made by Untiher in addition to Employee contributions.
• Life insurance: 2X employees Annual salary paid by Unither. Supplemental Life Insurance offered for Employee, Spouse or Domestic Partner and Children.

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!