Microbiologist II

Piramal Pharma Limited; Lexington (KY); On-site; USD 55,000 - 75,000; Full time

Job summary

Piramal Pharma Limited in Lexington, KY is looking for a Microbiologist II to perform microbiological testing of raw materials and finished products. The role requires 2+ years of lab experience and a B.S. in Microbiology, Biology, or a related field.

Key responsibilities include developing microbiological methods, maintaining compliance with laboratory SOPs, and training team members. The position offers a comprehensive environment focused on QA and compliance within the pharmaceutical industry.

Qualifications

• 2+ years of practical laboratory experience in a manufacturing environment.
• Competency with microbiology techniques such as Gram staining and microorganism identification.
• Must understand basic lab safety and waste disposal practices.

Responsibilities

• Perform microbiological testing of raw materials and finished products.
• Prepare protocols and reports related to microbiological methods.
• Train team members in microbiology and chemistry laboratories.

Skills

Microbiological techniques

GMP compliance

Documentation practices

MS Office proficiency

Education

B.S. in Microbiology, Biology, Life Sciences

Tools

Autoclaves

Light microscope

Biohazard cabinets

Job description

## Microbiologist IIApplylocations: Lexington,KYposted on: Posted Yesterdayjob requisition id: R00002144***Be the First to Apply*****Division**Piramal Pharma SolutionsPiramal 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.comJob TitleMicrobiologist IIJob DescriptionBusiness: 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 - Saturday2pm 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)