Sr. Microbiologist

Piramal Pharma Limited; Lexington (VA); On-site; GBP 68,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in Lexington seeks a Senior Microbiologist to provide subject-matter expertise for audits, data review, and lab expansion projects. Reporting to the Microbiology Manager, you will lead cGMP-compliant activities, develop SOPs, and support regulatory readiness.

The role requires a BS in Microbiology or life sciences, 5–7 years in high-throughput microbiology, and hands-on experience with lab instrumentation. Strong documentation and QA collaboration are essential.

Qualifications

• BS in Microbiology or related life sciences.
• 5-7 years of experience in high-throughput microbiology laboratories in a commercial pharmaceutical, GMP manufacturing environment.
• Experience with Gram staining, isolation plating, media preparation and microorganism identification methods.
• Experience with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system.
• Hands-on experience with basic lab equipment such as pH meters and balances (and related microbiology equipment).
• Strong documentation practices and GMP compliance with data entry forms and attention to detail.
• Knowledge of cGMPs and regulatory expectations in pharma.
• MS Office proficiency (Word, Excel, Access, Outlook).
• Lab safety and waste disposal practices.

Responsibilities

• Prepare, review, and approve SOPs, Test Methods, Protocols, Reports, Trending Reports, Data Review, CCRs, CAPAs, Risk Assessments, etc.
• Provide cGMP and lab training to the Micro staff as well as technical support and troubleshooting and train analysts in laboratory practices and standard microbiological procedures.
• Lead laboratory investigations, deviations, and implementation of CAPA’s. Write and review SOP’s.
• Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries as subject matter expert, as needed.
• Support process improvements and expansion growth
• Develop and implement procedural guidelines within the Microbiology laboratory in conjunction with Quality Assurance.
• Participate in development of cleaning validation/verification, environmental monitoring and control program, utilities, and HVAC monitoring program, sterility and microbial enumeration tests.
• Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for incorporation of latest requirements into best practices.
• Work with Microbiology management to maintain environmental monitoring, testing schedules and assess testing priorities.
• Monitor calibration of equipment and identify new equipment needs.
• Perform other related duties as required.

Skills

Good Laboratory Practices

Microbiology Techniques

MS Office

Documentation

Regulatory Awareness

Education

B.S. in Microbiology or Life Sciences

Tools

Autoclaves

Air samplers

Light microscope

Biohazard cabinets

Water purification system

Job description

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.com

Job Title

Sr. MicrobiologistJob Description

Business: Pharma Solutions

Department: Microbiology

Location: Lexington

Job Overview

Reporting to the Microbiology Manager, the Senior Microbiologist will be responsible for providing technical expertise as the subject matter expert for audits, data review, and lab expansion projects.

Reporting Structure

This position reports to the Microbiology Manager.

Key Responsibilities

• Prepare, review, and approve SOPs, Test Methods, Protocols, Reports, Trending Reports, Data Review, CCRs, CAPAs, Risk Assessments, etc.
• Provide cGMP and lab training to the Micro staff as well as technical support and troubleshooting and train analysts in laboratory practices and standard microbiological procedures.
• Lead laboratory investigations, deviations, and implementation of CAPA’s. Write and review SOP’s.
• Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries service as subject matter expert, as needed.
• Support process improvements and expansion growth
• Develop and implement procedural guidelines within the Microbiology laboratory in conjunction with Quality Assurance.
• Participate in development of cleaning validation/verification, environmental monitoring and control program, utilities, and HVAC monitoring program, sterility and microbial enumeration tests.
• Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into best practices.
• Work with Microbiology management to maintain environmental monitoring, testing schedules and assess testing priorities.
• Monitor calibration of equipment and identify new equipment needs.
• Perform other related duties as required.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field
• 5-7 years of Experience high throughput Microbiology Laboratories is required; with at least 3 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenterals and in a CMO/CDMO/Clinical Environment).
• 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
• undefined
• 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)
• undefined