Sr. Principal Scientist - Sterility Assurance Floor Leader

Role Summary

The Sr. Principal Scientist – TSMS Sterility Assurance Floor Leader provides technical leadership, management, and mentorship for a team of sterility assurance scientists and technical staff while ensuring compliance with regulatory requirements and industry best practices. The role leads and develops a team supporting floor activities for start-up and compliant manufacturing of Concord products, focusing on development and implementation of sterility assurance strategies including environmental monitoring, aseptic process simulations, facility cleaning, sanitization, and sterility risk management. The scope includes syringe filling operations for commercially manufactured products targeted for transfer to the Concord site.

Responsibilities

• Lead, develop, coach, and mentor a team of sterility assurance scientists (process team) to ensure technical depth and an engaged, inclusive workforce.
• Foster a collaborative workplace and ensure effective hiring and staffing.
• Provide day-to-day oversight for the sterility assurance scientists (process team) associated with routine operations and start-up/project objectives.
• Provide technical expertise and guidance in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.
• Collaborate cross-functionally with the area process teams for operational support and provide technical guidance for root cause investigations and deviation management.
• Lead sterility assurance related technical projects to improve process control, yield, product quality, and productivity.
• Author, review, and approve site plans, studies, and technical documents related to sterility assurance.
• Use risk management principles to evaluate processes and controls related to sterility assurance.
• Analyze microbial and manufacturing data using statistical principles to identify trends and process disruptions.
• Ensure audit and inspection readiness; support regulatory inspections, submissions, and partner/internal audits.

Qualifications

• Required: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
• Required: Prior experience in cross functional technical leadership roles.
• Required: In-depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance.
• Required: 5+ years supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.).

Skills

• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.
• Strong oral and written communication skills that demonstrate the ability to effectively communicate with all levels of the organization.
• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations.
• Demonstrated successful leadership of cross-functional teams.
• Experience with data trending and analysis.
• Ability to analyze complex data and solve problems.

Education

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.