Scientist / Senior Scientist - TSMS Sterility Assurance

Role Summary

Scientist / Senior Scientist - TSMS Sterility Assurance. Responsible for developing and implementing sterility assurance programs, providing technical guidance on environmental monitoring, contamination control, aseptic processing, gowning, cleaning, and disinfectant efficacy, and contributing to cross-functional initiatives to meet quality and business objectives.

Responsibilities

• Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
• Lead or provide technical oversight for activities related to sterility assurance programs including but not limited to; Airflow Pattern Testing, Environmental Monitoring Performance Qualifications, Aseptic Process Simulations, Cleaning, Sanitization, and Disinfection, Gowning within GMP Classified Areas, Aseptic Processing Techniques, Contamination Control.
• Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
• Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
• Lead/assist with support and/or provide technical expertise for developing the site‚Äôs contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies.
• Lead/assist with support and/or provide technical expertise for the facility‚Äôs cleanroom gowning and aseptic technique strategy/program.
• Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.
• Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements.
• Lead or provide technical support for root cause investigations associated with sterility assurance programs.
• Participate and/or provide technical sterility assurance support during internal and external audits.
• Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs.
• Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives.

Qualifications

• Bachelor‚Äôs or Master‚Äôs Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
• Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.

Skills

• Possess strong interpersonal skills to work cross-functionally within a team.
• Possess strong self-management and organizational skills.
• Possess strong oral and written communication skills for communicating to colleagues, management, and other departments.
• Experience with data analysis and trending.
• Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas.
• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.

Education

• Nothing to add beyond Qualifications.

Additional Requirements

• Role is Monday through Friday; flexible to support production schedules, shutdowns, and occasional extended hours or off-hour work; travel may be required during the project phase.
• Tasks may require repetitive motion and standing or walking for long periods.