Position Summary

The Principal Scientist – Sterility Assurance within Technical Services / Manufacturing Science (TS/MS) is a technical leadership role responsible for developing, implementing, and sustaining sterility assurance and environmental monitoring strategies at a parenteral drug product manufacturing site.

This role supports the start-up, validation, and routine manufacturing of aseptically produced products, including environmental monitoring programs, aseptic process simulations, facility sanitization, contamination control, and sterility assurance risk management. Responsibilities span across technical oversight, process team support, data analysis, and continuous improvement initiatives to ensure compliant and robust sterile manufacturing operations.

Key Responsibilities

Technical Leadership & Process Support

• Provide technical guidance and oversight of aseptic processing activities to operational Process Teams.
• Support or lead investigations related to sterility assurance, including root cause analysis and remediation.
• Perform scientific and risk-based evaluations of aseptic processes, environmental monitoring, disinfectant efficacy studies, sanitization programs, and contamination control strategies.
• Support start-up and tech transfer activities related to sterile manufacturing operations.

Data Analysis & Program Performance

• Analyze microbial, manufacturing, and environmental monitoring data using statistical principles to identify trends, process disruptions, and improvement opportunities.
• Conduct periodic review of EM program performance and recommend enhancements to ensure a state of control.
• Use risk management tools to evaluate proposed processes and associated controls for microbial, particulate, and endotoxin risk.

Documentation & Compliance

• Create, execute, review, and/or approve technical documents, including protocols, reports, procedures, and change controls.
• Support internal and external audits by providing subject-matter expertise in sterile manufacturing, environmental monitoring, and contamination control.
• Participate in continuous improvement projects aimed at strengthening quality systems and sterility assurance programs.

Cross-Functional Collaboration

• Collaborate with MSAT, QA, Operations, and cross-functional technical teams to drive alignment on sterility assurance objectives.
• Support technical projects focused on improving process reliability, yield, and quality.
• Network with site and network-level sterility assurance professionals to harmonize aseptic standards and contamination control strategies.

Training & Development

• Provide sterility assurance mentoring, training, and knowledge-sharing to support personnel competency and strengthen sterile manufacturing culture.
• Remain current with evolving regulatory expectations, industry trends, and best practices in aseptic processing and contamination control.

Requirements (Education, Experience, Training)

• BS or MS in Microbiology, Biology, Biochemistry, Chemical/Biochemical Engineering, or related scientific discipline.
• Experience with parenteral drug product manufacturing in a cGMP environment.
• Experience supporting cGMP operations in areas such as environmental monitoring, sterility assurance validation, contamination control, technical services/MSAT, microbiology laboratory, or quality assurance.

Preferred (Not Required)

• Experience in facility start-up, technical transfer, or commissioning/qualification—particularly related to environmental monitoring performance qualification or aseptic process simulations.
• Demonstrated success leading cross-functional teams.
• Experience with data trending, statistical evaluations, and complex problem-solving.
• Strong interpersonal, teamwork, communication, and organizational skills.
• Ability to clearly document and communicate technical information across organizational levels.

Additional Information

• Standard schedule is Monday–Friday; flexibility is required to support production schedules, shutdowns, extended hours, or off-shift support as needed.
• Role is based on-site in RTP