Microbiologist II

US-IL-Chicago
2 months ago
ID
2017-1941
Adello Biologics, LLC

Overview

Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

 

Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking Microbiologist II contractors to be based out of our Chicago, IL location. 

Responsibilities

EM and Utilities monitoring and testing.

o    Performs environmental monitoring of Adello Biologics LLC controlled and classified manufacturing areas.

  • Get gowned as specified to access the manufacturing areas.
  • Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles. Incubates viable samples.
  • Streaks and sends representative EM isolates to contract laboratory for identification.

o    Performs sanitation and temperature verification of laboratory refrigerators and incubators.

o    Performs routine monitoring for water for injection (WFI) system, including collection of incoming and purified water.

  • Performs TOC/Conductivity of purified water and WFI samples.
  • Performs tests THC and Bioburden tests.
  • Submits samples for testing to microbiology laboratory or contracted laboratory for Nitrates and Coliform.

o    Performs routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, oil, and moisture.

o    Performs visual inspection of microbiological tests and EM samples.

o    Performs data entry of results in Excel for trend analysis.

o    Reviews microbiology laboratory data.

o    Generates Out of EM Action/Alert Levels Notification, when required.

o    Other tasks as requested by management.

Qualifications

PREREQUISITES:

Education:

  • A Bachelor’s degree in microbiology, biology, or related discipline.

Experience:

  • At least 3-5 years of experience in a cGMP pharmaceutical manufacturing environment is required.
  • Working knowledge of cGMP regulations (21 CFR 201/211/820) is required.

 

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Good written and verbal communication skills.
  • Use of air sampling EM equipment, such as AirIdeal, HACH Met Ones 3440 Series, Lasair III, and MiniCapt.
  • Good organizational skills.
  • Detail oriented.
  • Must be able to effectively manage time to complete assignments.
  • Familiarized with the use of Microsoft Excel and Microsoft Word.

 

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

General Work Environment:

  • General office setting and laboratory settings.
  • Able to work wearing a full aseptic gowning at least 4 hours once weekly.
  • Flexibility working weekend, holidays, or more than 8 hours a day, as required.
  • Exposure to hazardous chemical, such as disinfectants, may occur, requiring personal protective equipment.
  • Safety alertness is required due to work around hazardous equipment and conditions.

 

Noise:

  • Possible exposure to moderate noise levels.

 

Standing/Lifting:

  • Must be able to lift up to 25 lbs.

 

Visual:

  • No special requirements.

 

Stress:

  • High-paced demanding environment to meet ambition goals.

 

Travel:

  • No travel required.

 

Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training

 

Notice To Agency And Search Firm Representatives

Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed