Principal Scientist – Sterility Assurance Jobs

Medasource

Location:
United States, Durham

Category:
IT - Administration

Contract Type:
Not provided

Salary:

65.00 USD / Hour

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Job Description:

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.

Job Responsibility:

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
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
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
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
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:

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

Nice to have:

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

What we offer:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays
We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc

Additional Information:

Job Posted:
December 10, 2025

Work Type:

On-site work

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Principal Scientist – Sterility Assurance