• Manager, Microbiology & EM

    Location US-IL-Chicago
    Posted Date 1 month ago(10/15/2018 1:35 PM)
    ID
    2018-2205
    Company
    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 Manager, Microbiology & EM to be based out of our Chicago, IL location.

    Responsibilities

    SUMMARY:

    The Manager, Microbiology & Environmental Monitoring is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. This employee is responsible for leading the Microbiology and Environmental Monitoring (EM) department.

     

    Essential Duties and Responsibilities:

    • Ensure laboratory tasks are distributed and clear with the aid of a schedule, as required.
    • Ensure the Environmental Monitoring (EM) of ADELLO-controlled and aseptic manufacturing areas for the detection of viable (surface and air) and non-viable (air) particles is in place.
    • Ensure the routine monitoring for clean compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, oil, and moisture is in place.
    • Ensure the routine monitoring for water for injection (WFI), reverse osmosis (RO), purified water (PW), and pure steam (CS) systems is in place.
    • Coordinates the analytical testing of water and pure steam samples with contracted laboratory (TOC and conductivity).
    • Supports the manufacturing of Drug Product (DP) by supporting the annual gowning qualification and routine monitoring of personnel involved in the aseptic manufacturing of the DP and the EM of the aseptic filling process.  
    • Works closely with Manufacturing, Technology and Materials Management teams to assure the in house and outsourced testing of raw materials, cleaning validation, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples, as required.
    • Performs or coordinates the microbiological testing for multiple projects including Bacterial Endotoxin, Sterility, Microbial Count, Bioburden, microbial identification and/or Gram Stains.
    • Support Site Media Fill Program Performs ensuring EM and personnel gowning monitoring during filling activities, the visual inspection of incubated media fill units, the Growth Promotion Test of the media fill batch.
    • Ensure adherence to all policies and compliance with cGMP documentation, Good Microbiology Laboratory Practices, FDA and ICH guidelines in all laboratory operations.
    • Responsible for the safety of Microbiology Laboratory personnel at the laboratory.
    • Ensure that the laboratory equipment has been calibrated, standardized or monitored as appropriate for its applicable function in the laboratory.
    • Coordinate purchase of reagents and supplies as required.
    • Maintain trending systems for Water and EM and ensure appropriate control of these systems is maintained.
    • Review QC Data, prepare certificates of analysis, reports and quality documents, as required.
    • Lead laboratory investigations (OOS/OOT) and support manufacturing investigations, when required.
    • Lead and close investigations and CAPAs (corrective action/preventive action implementation).
    • Support the start-up process of Microbiology Laboratory at ADELLO, Chicago Site.
    • Lead and support the validation of Microbiological tests method related with ADELLO products manufacturing. 
    • Write, review and approve QC SOPs, test methods, test records, and technical reports to ensure compliance with site and regulatory requirements.
    • Support the recruitment process for new experienced analysts.
    • Leads the professional development of QC Microbiology Analysts.
    • Represent the laboratory in external and internal compliance audits, when required.
    • Represent the laboratory outside ADELLO Chicago Site in global activities, when required.
    • Occasional off hours, weekend and holidays support required.
    • Other tasks as requested by management.

    Qualifications

    PREREQUISITES:

    Education:

    • A Bachelor’s degree in biology, microbiology, or related field with more than 10 years of experience, or a Master’s or Doctorate degree biology, microbiology, or related field with 7 years of experience.

    Experience:

    • Previous experience in a cGMP pharmaceutical manufacturing environment is required.
    • Working knowledge of cGMP regulations (21 CFR 201/211/820) is required.
    • At least 2 years of experience as Laboratory Supervisor/Manager in a regulated drug manufacturing facility.
    • Strong cGMP compliance experience.
    • Environmental Monitoring for Viable (air and surface) and Non-Viable (air) Particles.
    • Water Sampling and Microbial Count and Bacterial Endotoxin Testing.
    • Bioburden, Bacterial Endotoxin, inspection for growth, Gram Stain methods, and identification of species.
    • Trend Reports, Qualification Reports Diverse industry experience a plus (e.g. experience with biosimilars and start-ups).

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    • Good written and verbal communication skills.
    • Strong presentation skills and ability to communicate effectively both internally and externally
    • Excellent oral and written communication skills.
    • Ability to multi-task, prioritize and adjust schedules to meet changing business needs.
    • Good work ethic and flexible attitude; demonstrated interest in career growth and the desire to support and work well in a team.
    • Good organizational skills.
    • Detail oriented.
    • Must be able to effectively manage time to complete assignments.

     

    WORK ENVIRONMENT AND PHYSICAL DEMANDS:

    General Work Environment:

    • General office environment.
    • May be required to work in or walk through laboratory settings.

    Noise:

    • No extraordinary noise levels.

    Standing/Lifting:

    • Must be able to walk to and through manufacturing cleanroom settings.
    • Must be able to life at least 25 lbs.

    Visual:

    • No extraordinary requirements.

    Stress:

    • High-paced demanding environment to meet ambitious project 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, 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.

     

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