Kashiv Pharma, LLC. Microbiology Analyst III in Chicago, Illinois
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 Microbiologiy Analyst III to be based out of our Chicago, IL location..
The Microbiology Analyst III, Microbiology and Environmental Monitoring (EM) is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. This employee is responsible for supporting the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site’s microbiology and EM programs as well as the overall microbiology laboratory operations to ensure compliance with current regulations. This position requires direct interaction with the manufacturing processes related to biological non-sterile drug substance and sterile drug product. The employee’s qualification in aseptic gown is required.
Essential Duties and Responsibilities:
Responsible for the following tasks and any other as assigned by laboratory management.
Reviews microbiology laboratory data.
Performs data entry of results in Excel for trend analysis.
Perform data trend analysis reports.
Generates OOS, Event Reports, Environmental Notifications and Utilities Notifications.
Lead laboratory investigations and/or support manufacturing investigations.
Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes.
Lead procedures, methods or specifications revisions acting as Contributor using Master Control System.
Lead method or process validation initiatives in the laboratory.
Perform managerial work such as prepare laboratory schedule, when required.
Act as supervisor whenever management is out of Site.
Represent the laboratory in local and global activities.
Perform the following monitoring/tests as required:
Total Heterotrophic Count (THC) and Bioburden tests by membrane filtration.
Bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.
Growth Promotion Test of EM and Microbiology testing culture media.
Gram stain of EM isolates.
TOC/Conductivity testing of water and equipment flushes samples.
Routine monitoring of water for injection (WFI), purified water (PW), and clean steam (CS) systems.
Submits samples for testing to microbiology laboratory or contracted laboratory for TOC/Conductivity, Nitrates, Coliforms, Total Heterotrophic Count (THC) and Bacterial Endotoxin, as needed.
Routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, oil, and moisture.
Collects samples for the detection of moisture, viable and non-viable particles.
Incubates and inspects viable samples for microbial growth.
Routine environmental monitoring of controlled and aseptic manufacturing areas.
Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.
Incubates and inspects viable samples for microbial growth.
Perform the following tasks, as needed.
Sanitation and temperature verification of laboratory refrigerators and incubators.
Submits samples for testing to a qualified contracted laboratory.
Streaks representative EM and Microbiological tests isolates.
Sends applicable isolates to contract laboratory for identification.
Receives results and performs data entry for trend analysis.
Complies with annual gowning qualification, as required.
Performs visual inspection of media fill units.
A Bachelor’s degree in microbiology, biology, or related discipline.
A master degree is desired.
At least 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.
Able to work with a team as well as independently.
Good organizational skills.
Detail and quality oriented.
Must be able to effectively manage time to complete assignments.
Familiarized with the use of Microsoft Excel and Microsoft Word.
Experience using the following equipment is ideal:
EM air sampling: AirIdeal, HACH Met Ones 3440 Series, Lasair III, and MiniCapt.
Bacterial Endotoxin: Biotek reader/ LONZA
THC/Bioburden: Millipore filtration pump.
Sievers TOC/Conductivity Analyzer
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.
No extraordinary noise
Must be able to lift up to 25 lbs.
No special requirements.
High-paced demanding environment to meet ambition goals.
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, 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.
External Company Name: Amneal Enterprises LLC
External Company URL: http://amneal.com/