Microbiologist II

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 60,000 - 76,000; Full time

Job summary

Piramal Pharma Solutions Inc. in Lexington, KY, is seeking a Microbiologist II to perform microbiological testing of raw materials, in-process, and finished products, ensuring SOP and GMP adherence. Shift: Tue-Sat 2pm–10pm or 3pm–11pm; reports to Microbiology Manager.

Ideal candidates hold a BS in Microbiology or related field with 2+ years in manufacturing labs and strong documentation skills. Proficiency with MS Office and lab instrumentation is required.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field.
• 2+ years of practical laboratory experience in a manufacturing environment.
• Experience with GMP documentation and data entry with attention to detail.
• Knowledge of microbiology techniques including Gram staining, isolation plating, media prep, and ID methods.
• Experience with common microbiology instrumentation such as autoclaves, air samplers, microscope, biosafety cabinets, and water systems.
• Hands-on experience with basic lab equipment (pH, balances, water baths, etc.).
• Understanding of lab safety, biohazard and chemical waste disposal.
• Knowledge of cGMPs and pharma industry expectations.
• MS Office proficiency (Word, Excel, Access, Outlook).

Responsibilities

• Develop microbiological test methods and validations.
• Perform microbiological testing of raw materials, in-process, and finished products for release.
• Prepare protocols, final reports, and test methods for development and validation.
• Perform growth promotion and maintenance of cultures.
• Support facilities to resolve nonconformances and CAPA actions as related to environmental monitoring.
• Complete environmental monitoring and related investigations; document results.
• Maintain GMP/GLP documentation relevant to duties.
• Maintain laboratory instrumentation and ensure cleanliness per SOPs.
• Assist in review of test data and report deviations to supervisor.
• Coordinate with other departments and external vendors to meet goals.
• Assist management in writing/updating SOPs.
• Participate in projects with QC and/or Microbiology teams.
• Train team members in microbiology and chemistry labs as required.
• Ensure proper handling and disposal of biohazard material per OSHA and SOPs.
• Contribute to quality system documentation (CAPA, investigations, changes control).
• Prepare microbiological trending reports and protocols.
• Perform other related duties as required.

Skills

Microbiology techniques

GMP compliance

Documentation practices

MS Office proficiency

Education

BS in Microbiology/Biology/Life Sciences

Tools

Autoclaves

Air samplers

Light microscope

Biohazard cabinets

Water purification system

Job description

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 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)

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 character protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements.