Sr. Microbiologist

Piramal Pharma Solutions Inc.; Lexington (KY); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions in Lexington is seeking a Senior Microbiologist to serve as the subject matter expert for audits, data review, and lab expansion projects. You will provide technical support to the microbiology team and ensure the lab meets regulatory expectations.

You will prepare and review SOPs, train staff on cGMP practices, lead investigations, and support regulatory inquiries. The role drives continuous improvement in environmental monitoring and testing programs.

Formación

• B.S. in Microbiology, Biology, Life Sciences, or related field.
• 5-7 years of experience in high throughput microbiology laboratories in pharma GMP environments.
• Experience with Gram staining, isolation plating, media prep and microorganism ID methods.
• Experience with autoclaves, air samplers, light microscope, biosafety cabinets and water systems.
• Strong documentation practices and GMP compliance.
• MS Office proficiency: Word, Excel, Access, Outlook.

Responsabilidades

• Prepare, review, and approve SOPs, test methods, protocols, reports, CAPA-related documents.
• Provide cGMP training, technical support, and train analysts in microbiology practices.
• Lead investigations, deviations, CAPA implementation, and SOP reviews.
• Provide QC data and information to regulatory personnel during inspections.
• Support process improvements and expansion initiatives.
• Develop procedural guidelines within Microbiology with QA.
• Participate in cleaning validation, environmental monitoring, and related testing programs.
• Monitor FDA publications and industry guidelines to inform best practices.
• Collaborate with management to set testing priorities and equipment needs.
• Perform other related duties as required.

Conocimientos

Microbiology

GMP compliance

Lab techniques

Data review

Educación

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

Herramientas

Autoclaves

Air samplers

Light microscope

Biohazard cabinets

Water purification system

pH meters

Balances

Water baths

Descripción del empleo

Be the First to Apply 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 Sr. Microbiologist

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.

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

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.