Sr. Microbiologist
Piramal Pharma Ltd
Summary
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.
Job description
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.
Requirements
- B.S. in Microbiology, Biology, Life Sciences, or related field
- 5-7 years of Experience high throughput Microbiology Laboratories is required
- 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
- 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)
Company overview
Piramal Pharma Limited (PPL) is a diversified global pharmaceutical company with operations spanning three core business verticals: Contract Development and Manufacturing Organisation (CDMO), Complex Hospital Generics (CHG), and India Consumer Healthcare. Headquartered in India, the company operates 17 development and manufacturing facilities across India, the United Kingdom, and North America, with commercial presence in over 100 countries worldwide. As a leading integrated pharmaceutical services provider, Piramal Pharma offers end-to-end capabilities from drug discovery and development to commercial manufacturing, serving both innovator pharmaceutical companies and generic manufacturers. The company has established strong market positions, ranking as the fourth largest global player in inhalation anesthesia and maintaining leadership in intrathecal therapy segments. With a workforce of over 6,200 employees and a commitment to best-in-class quality standards, Piramal Pharma has maintained a strong regulatory compliance record, successfully clearing numerous FDA and international inspections. The company's diversified business model and global footprint position it as a significant player in the pharmaceutical manufacturing and services sector, driving innovation and accessibility in healthcare solutions across developed and emerging markets.