Senior Pharmaceutical Microbiologist

Placements24; Mossel Bay; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Medical aid and provident fund

Professional development

Flexible hours within remote framework

Annual leave

Job summary

Placements24 is seeking a Senior Pharmaceutical Microbiologist for its Mossel Bay facility in Western Cape. You will lead microbiological testing across materials and finished products, develop and validate methods, and ensure GMP/ regulatory compliance while supporting QA/QC operations.

The role offers a Yes remote work arrangement with flexibility, while maintaining essential quality oversight within a dynamic biopharma environment. Strong communication and leadership are essential.

Qualifications

• PhD or Master in Microbiology or related life science field.
• Minimum 5 years in pharmaceutical microbiology, QA/QC focus.
• Hands-on experience with standard microbiology techniques.
• Familiarity with USP/EP/BP and regulatory guidelines.
• Experience in aseptic work and cleanroom environments.

Responsibilities

• Oversee and perform microbiological testing on materials and products.
• Develop, validate and transfer microbiological methods.
• Investigate OOS results, deviations and CAPAs.
• Maintain calibration of laboratory equipment and ensure QC compliance.
• Prepare technical reports and regulatory submissions.

Skills

Pharmaceutical microbiology

cGMP compliance

Environmental monitoring

Method development & validation

OOS investigation & CAPA

Education

PhD in Microbiology

MS in Microbiology

Tools

LAL endotoxin testing

Sterility testing

Microbiological testing equipment

Job description

About the Role

Our client, a leading biopharmaceutical company, is seeking an accomplished and highly motivated Senior Pharmaceutical Microbiologist to join their quality control and assurance team in Mossel Bay, Western Cape . This role is crucial for ensuring the microbiological safety and integrity of our pharmaceutical products throughout their lifecycle. You will be responsible for overseeing and executing a range of microbiological tests, developing and validating new methods, and ensuring compliance with all relevant regulatory standards. The ideal candidate will possess deep expertise in pharmaceutical microbiology, strong analytical skills, and a commitment to maintaining the highest quality standards. This is an excellent opportunity to contribute to patient safety and product quality in a dynamic and innovative environment. This position offers a Yes remote work arrangement, allowing for flexibility while maintaining essential quality oversight.

Key Responsibilities

• Oversee and perform a wide range of microbiological testing on raw materials, in-process samples, finished products, and environmental monitoring.
• Develop, validate, and implement new microbiological testing methods and procedures in accordance with pharmacopoeial and regulatory requirements.
• Investigate out-of-specification (OOS) results, deviations, and microbial contamination events, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Maintain and calibrate laboratory equipment, ensuring optimal performance and compliance with calibration schedules.
• Ensure compliance with cGMP, ISO, and other relevant regulatory guidelines pertaining to pharmaceutical microbiology.
• Conduct risk assessments related to microbiological contamination and implement appropriate control strategies.
• Train and mentor junior laboratory personnel on microbiological techniques and best practices.
• Prepare and review technical reports, method validation protocols, and summaries for regulatory submissions.
• Stay current with advancements in pharmaceutical microbiology, regulatory expectations, and industry trends.

Requirements

• Ph.D. or Master's degree in Microbiology, Medical Microbiology, or a related life science discipline.
• A minimum of 5 years of progressive experience in pharmaceutical microbiology, with a focus on quality control and assurance.
• Extensive hands-on experience with standard microbiological techniques, including microbial enumeration, identification, sterility testing, endotoxin testing (LAL), and environmental monitoring.
• Proven ability to develop, validate, and transfer microbiological test methods.
• In-depth knowledge of cGMP, pharmacopoeias (USP, EP, BP), and relevant regulatory guidelines (e.g., FDA, EMA).
• Experience with aseptic techniques and working in cleanroom environments.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills, including the ability to prepare clear and concise technical documentation.
• Demonstrated ability to work independently and as part of a team in a remote setting.

Benefits

• Competitive salary package, reflecting your experience and expertise, with opportunities for performance-based incentives.
• Comprehensive medical aid and a provident fund are provided to support your health and financial well-being.
• Excellent professional development opportunities are available through continuous training, workshops, and support for attending relevant scientific conferences.
• Additional benefits include generous annual leave, flexible working hours within the Yes remote framework, and access to employee wellness resources.

The company fosters a culture of scientific excellence and innovation.

This role is based in Mossel Bay, Western Cape and is an integral part of our quality assurance operations.