Piramal Pharma

CDMO and hospital generics, consumer health

Microbiologist 2

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeLexington, KY, USANo salary listedIn-person

About the Job

Requirements

A B.S. in Microbiology, Biology, Life Sciences, or a related field is required.
At least 2 years of practical laboratory experience in a manufacturing environment is required.
Experience with general documentation practices and good manufacturing practice (GMP) compliance, including data-entry forms, with attention to detail is required.
Working knowledge and practical experience with good laboratory practices in a microbiology laboratory environment are required.
Competency in microbiology techniques such as Gram staining, isolation plating, media preparation, and microorganism identification methods is required.
Experience with common microbiology laboratory instrumentation, especially autoclaves, air samplers, light microscopes, biohazard cabinets, and water purification systems, is required.
Hands-on experience with basic laboratory equipment such as pH equipment, balances, water baths, and other equipment common to microbiology methods is required.
Understanding of basic laboratory safety, biohazard handling, and chemical waste disposal practices is required.
Knowledge of current good manufacturing practices (cGMPs) and pharmaceutical industry expectations is required.
Intermediate proficiency in Microsoft Word, Microsoft Excel, Microsoft Access, and Microsoft Outlook is required.

Responsibilities

Develop microbiological test methods and method validations.
Perform microbiological testing of raw materials, work-in-process, and finished products for product approval and release.
Prepare protocols, final reports, and test methods related to the development and validation of microbiological methods.
Perform growth promotion of media and maintain bacterial cultures.
Support the facility in resolving nonconformance issues and identifying corrective and preventive actions related to environmental monitoring excursions.
Complete environmental monitoring and laboratory-related investigations and properly document results.
Maintain good manufacturing practice (GMP) and good laboratory practice (GLP) documentation relevant to assigned duties and responsibilities.
Maintain laboratory instrumentation required for testing and keep the laboratory clean according to standard operating procedure guidelines.
Assist in reviewing test data and report deviations to a supervisor.
Interact and coordinate activities with other departments and external vendors to support facility goals and objectives.
Assist management in writing and updating standard operating procedures (SOPs).
Participate in projects involving the Quality Control and/or Microbiology departments.
Train team members in microbiology and chemistry laboratories as required.
Ensure proper handling and disposal of biohazard material in compliance with Occupational Safety and Health Administration (OSHA) requirements and standard operating procedures.
Compose and assist with quality systems documentation, including failure investigations, corrective and preventive actions (CAPA), calibration, and change control.
Compose microbiological trending reports and protocols.
Perform other related duties as required.

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Microbiologist II

Job Description

Business: Pharma Solutions
Department: Microbiology (MQC)
Location: Lexington

Job Overview

Reporting to the Microbiology Manager, the primary purpose of the role is to perform microbiological testing of raw materials, work-in-process, and finished products, while maintaining compliance of laboratory standard operating procedures.

Work Schedule

Tuesday - Saturday

2pm to 10pm or 3pm to 11pm

Reporting Structure

This position reports to the Microbiology Manager

Key Responsibilities:
•   Develop microbiological test methods and method validations.
•   Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
•   Prepare protocols, final reports, and test methods related to the development and validation of microbiological methods.
•   Perform growth promotion of media and maintenance of bacterial cultures.
•   Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions
•   Complete environmental monitoring and laboratory related investigations and properly document results.
•   Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
•   Maintain laboratory instrumentation required for testing and cleanliness of the laboratory per SOP guidelines.
•   Assist in the review of test data and report any deviations to supervisor.
•   Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives
•   Assist management in writing/updating Standard Operating Procedures (SOPs)
•   Participate in projects involving the Quality Control and/or Microbiology departments
•   Train team members in microbiology and chemistry laboratories as required
•   Ensure proper handling and disposal of biohazard material in compliance with OSHA and Standard Operating Procedures
•   Compose and assist with quality systems documentation such as failure investigations, CAPA, calibration, changes control, etc.
•   Compose microbiological trending reports and protocols
•   Perform other related duties as required

Qualifications:

• B.S. in Microbiology, Biology, Life Sciences, or related field

•   2+ years of practical laboratory experience in a manufacturing environment
•   Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details
•   Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods
•   Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system.
•   Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods.

•   Must understand basic lab safety, bio-hazard and chemical waste disposal practices
•   Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details.
•   Knowledge of cGMP’s and understand the pharmaceutical industry expectations
•   Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)

About the Company

Piramal Pharma

CDMO and hospital generics, consumer health

Piramal Pharma is a diversified pharmaceutical group with three divisions: Piramal Pharma Solutions (PPS), Piramal Critical Care (PCC), and the Consumer Products Division (CPD). PPS operates as a contract development and manufacturing organization, providing development and manufacturing services across the drug lifecycle for clients in North America, Europe, and Asia through a globally connected network. PCC specializes in complex hospital generics, particularly inhaled anesthetics, serving markets in the USA, Europe, and over 100 countries. CPD leads consumer healthcare in India with brands such as Littles, Lacto Calamine, i-pill, Tetmosol, Polycrol, and Tri Activ, and the company serves pharmaceutical companies, hospitals, and consumers by leveraging its manufacturing scale and distribution network.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Maharashtra, India
Founded: 2020

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