Senior Microbiologist *PC 639

Miltenyi Biotec Inc; East Hampshire; On-site; USD 119,000 - 162,000; Full time

Job summary

An established industry player is seeking a Microbial Control Specialist to lead and innovate microbial control strategies in a dynamic, multi-product environment. This role is pivotal in ensuring compliance with aseptic procedures and regulatory standards while mentoring staff and driving improvements in quality control processes. The ideal candidate will possess extensive experience in microbiology within GMP settings, showcasing strong problem-solving skills and a commitment to excellence. Join a team dedicated to advancing biomedical research and making a significant impact in gene therapy development, all within a supportive and inclusive work environment.

Qualifications

• 8+ years of experience in biotech or pharma industry with GMP/ISO environments.
• Competency in endotoxin and sterility testing, microbiological contamination.

Responsibilities

• Develop and qualify environmental monitoring and microbiological QC assays.
• Support contamination control strategy and provide microbiological support for audits.

Skills

Organizational Skills

Communication Skills

Teamwork Skills

Education

Degree in Microbiology

Degree in Biology

Degree in Engineering

Tools

GMP Standards

ISO Standards

Job description

Description

Your Tasks:

This position is responsible for planning, coordinating, and facilitating microbial control activities required for products manufactured in San Jose MBI. The role will interact with all site and cross-site functions that could impact San Jose's microbial control program, including Facilities, QC Microbiology, Manufacturing, and Process Development.

Essential Duties and Responsibilities:

1. Responsible for the development, qualification, and performance of environmental monitoring and microbiological QC assays to support GMP manufacturing in a multi-product CGT facility. Implement new microbiology testing programs to support microbial control strategies and testing for EM/microbiology programs.
2. Support and oversee the site's contamination control strategy. Provide microbiological support for audits and inspection readiness programs.
3. Partner with Manufacturing to ensure compliance with aseptic procedures and practices according to regulatory requirements and industry guidance. Promote aseptic culture and provide subject matter expertise.
4. Support investigations related to microbial contamination, root-cause analysis, corrective actions, and remediation plans. Track and implement CAPAs related to microbiology and aseptic operations.
5. Assist in resolving problems, identifying trends, system improvements, and communicating updates and metrics to senior personnel.
6. Review and approve microbial control documents, including SOPs, validation and qualification reports, protocols, deviations, and change controls.
7. Mentor and train Quality and Operations staff.
8. Perform additional tasks as directed by senior management.

Requirements:

• Degree in Microbiology, Biology, Engineering, or related field; 8+ years of experience in biotech or pharma industry with GMP/ISO environments, or equivalent.
• Experience in microbiology, sterilization, validation, environmental controls, and contamination control.
• Competency in endotoxin and sterility testing, microbiological contamination, including alternative methods.
• Experience with regulatory interactions.
• Proven ability to troubleshoot microbiological and sterilization issues and implement effective CAPAs.
• Knowledge of regulatory standards, including EU and ISO.

Skills:

• Strong organizational, communication, and teamwork skills.
• Ability to communicate effectively at all levels and represent the company in inspections.

Physical Demands:

Regular walking, handling, reaching, talking, hearing, standing, climbing, stooping, kneeling, and lifting up to 25 pounds. Vision requirements include close, color, peripheral, and depth perception.

Work Environment:

Temperature-controlled, clean lab setting with standard lab equipment. Exposure to viruses and bacteria, requiring protective clothing. Moderate noise level.

Salary range: $119,200 - $161,300/year, plus benefits and potential bonuses.

Miltenyi Biotec is an EO employer and participates in E-Verify.

Join us in revolutionizing biomedical research and supporting the development of gene therapy products. We are committed to diversity and inclusion.

For more information, review the Know Your Rights notice from the Department of Labor.