Associate Principal Scientist – Environmental Monitoring/Microbiology

About the role

This newly created, standalone position reports directly to the Associate Director and serves as a vital component of the site’s "Vision Zero" contamination control strategy. Operating as an elite individual contributor, you will be responsible for reducing microbial risks across both upstream and downstream manufacturing assets.

Responsibilities

• Own the standalone development and execution of compliant, effective, and modern contamination control strategies within Cell Therapy.
• Facilitate standard Risk Assessments (RAs) to identify and control microbial mechanisms, and lead root cause analysis (RCA) investigations for contamination events or low-level trends.
• Dedicate approximately 5% of the week to high-impact, in-lab presence—leading shop-floor GEMBA walks to drive proactive microbial control through real-time observation, hands-on teaching, and active coaching of manufacturing personnel.
• Establish clear lines of communication between assets to ensure technical lessons learned are effectively shared on both local and global corporate platforms.
• Develop and deliver specialized aseptic awareness and contamination control training programs tailored to the needs of the cell therapy asset.
• Review, update, and align local SOPs, protocols, and change controls to ensure technical modifications do not negatively impact the site's microbial control posture.
• Partner closely with internal asset heads and represent the site during customer meetings to address contamination control data, trends, and preventive actions.

Requirements

• Experience: 5–10 years of advanced experience in Microbiology paired with 5–10 years of working knowledge in GMP manufacturing environments.
• Technical Mastery: Deep technical knowledge of cleanroom engineering, particle control mechanisms, and a strong regulatory understanding of environmental monitoring (EM) programs to proactively assess controls.
• Audit & Investigation Skills: Proven hands-on experience leading complex contamination investigations and a strong familiarity with major pharmaceutical industry regulations and guidelines.
• Matrix Influence: Advanced experience influencing and guiding cross-functional teams and driving site-wide operational change as a standalone technical expert.
• Soft Skills: Excellent communication skills with an ability to simplify complex data, resolve conflicts across assets, and deliver logical proposals under critical timelines.
• Education: Bachelor’s degree is required, with preference for degrees in Microbiology, Biochemistry, Biology, or a related Scientific field.
• Compliance Mindset: Uncompromising commitment to Data Integrity principles and cGMP guidelines in all aspects of execution.

Qualifications

• Experience: 5–10 years of advanced experience in Microbiology paired with 5–10 years of working knowledge in GMP manufacturing environments.
• Technical Mastery: Deep technical knowledge of cleanroom engineering, particle control mechanisms, and a strong regulatory understanding of environmental monitoring (EM) programs to proactively assess controls.
• Audit & Investigation Skills: Proven hands-on experience leading complex contamination investigations and a strong familiarity with major pharmaceutical industry regulations and guidelines.
• Matrix Influence: Advanced experience influencing and guiding cross-functional teams and driving site-wide operational change as a standalone technical expert.
• Soft Skills: Excellent communication skills with an ability to simplify complex data, resolve conflicts across assets, and deliver logical proposals under critical timelines.
• Education: Bachelor’s degree is required, with preference for degrees in Microbiology, Biochemistry, Biology, or a related Scientific field.
• Compliance Mindset: Uncompromising commitment to Data Integrity principles and cGMP guidelines in all aspects of execution.

Skills

• Microbiology
• GMP Manufacturing Environments
• Cleanroom Engineering
• Particle Control Mechanisms
• Environmental Monitoring Programs
• Contamination Investigations
• Data Integrity Principles
• cGMP Guidelines

Benefits

• Medical, dental and vision insurance
• PTO

Pay

Compensation programs that recognize high performance.

Schedule

Monday – Friday, 8:00 AM – 4:30 PM.