Job Description

This employee supports 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 & Responsibilities

• Performs environmental monitoring of TPI-controlled and aseptic 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. Receives results and performs data entry for trend analysis.
• Complies with annual gowning qualification.
• Performs sanitation and temperature verification of laboratory refrigerators and incubators.
• Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purifies water (PW), and clean steam (CS) systems.
• Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity, microbial count, and endotoxins.
• Performs routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, oil, and moisture.
• Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.
• Performs gram stain and growth promotion tests.
• Performs tests for bioburden and microbial limit.
• Performs visual inspection of microbiological, EM samples and media fill units.
• Performs data entry of results in Excel for trend analysis.
• Reviews microbiology laboratory data.
• Generates OOS or Out of EM Action/Alert Levels Notification, when required.
• Lead laboratory investigations and/or support manufacturing investigations, when required.
• Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes.
• Lead procedures, methods or specifications revisions acting as Contributor using Master Control System.
• Other tasks as requested by management.

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.

Special 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.

Work Environment & Physical Demands:

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.

Standing/Lifting:

Must be able to lift up to 25 lbs.

The salary range for this position ranges from $90,000 - $115,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.