Assistant I , Manufacturing

US-IL-Chicago
6 months ago
ID
2017-1906
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 a Assistant I , Manufacturing-1st, 2nd and 3rd shift hours to be based out of our Chicago, IL. location. 

Responsibilities

SUMMARY:

The Assistant I, Manufacturing is a regular employee in a full-time non-exempt position at Adello Biologics, LLC, in Chicago, IL, this employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Adello policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

 

Essential Duties and Responsibilities:

  • Will be assigned to the daily operations, working with:
  • Weighing and dispensing of material
  • Glasswasher and autoclave
  • Media and buffer preparation
  • Filtration systems
  • Inoculation of mammalian or cytokines cells
  • Fermentation and harvest
  • Chromatography columns
  • Tanks
  • Aseptic filling
  • Responsible for in-process testing, such as: pH, Conductivity, Spectrophotometer, Osmometer, Cell count, YSI, Blood Gas Analyzer (BGA), etc.
  • Will verify all raw materials and commodities.
  • Responsible of equipment’s assembly, cleaning, sterilization and operation.
  • Prepares media and buffer solutions.
  • Will electronically record all the process steps.
  • Completes Batch Records and other cGMP documentation accurately and in a timely manner.
  • Remove and dispose soiled materials from the manufacturing area.
  • Will assure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
  • Will report all nonconformance or events that arise during the shift to the Supervisor.
  • Assists in the transfer of technology from Process Development to cGMP Manufacturing.
  • Complies with all safety, cGMP and Company policies, practices and procedures.

Qualifications

PREREQUISITES:

Education:

  • Associate degree in Science, major in Biology, Chemistry or Biotechnology with at least two years of experience in biotechnology field OR
  • BS degree in a Biotechnology, Biology or Chemistry with less than two years of experience in biotechnology field OR
  • Minimum 3 years experience in GMP environment for pharmaceutical or biopharmaceutical company.

         Experience:

  • Zero to 2 years of experience in biotechnology field.
  • Aseptic techniques and clean room manufacturing experience, is preferred.

.

SPECIALIZED KNOWLEDGE AND SKILLS:

Language:

  • Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
  • Excellent interpersonal skills.

Reasoning Skills:

  • The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
  • Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
  • Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.

Computer and/or Technical Skills:

  • Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
  • Operation and understanding of word processing, spreadsheets, and data management
  • Knowledge of GMP and safety requirements.
  • Knowledge of biotechnology operations such as:, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Osmometer, Weigh Scales, etc.

 

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

General Work Environment:

  • Manufacturing clean rooms
  • Willing to work in any of the three shifts or rotate Shifts and work weekends as required by the Operations.

 

Noise:

  • Possible moderate noise levels due to manufacturing.

 

Standing/Lifting:

  • Extended periods of standing and walking while working in the manufacturing areas
  • Must be able to lift 25 lbs.

 

Visual:

  • Eye test for prescription safety glasses is required

 

Stress:

  • High paced demanding environment to meet ambitious project goals.

 

Travel:

  • Limited travel will be required, but not exceed 5%. 

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, and 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