Scientist / Senior Scientist - TSMS Sterility Assurance

Role Summary

Scientist / Senior Scientist - TSMS Sterility Assurance. The position focuses on developing and implementing sterility assurance programs, providing technical guidance on environmental monitoring, contamination control, aseptic processing, gowning, cleaning, and disinfectant efficacy, to support sterile parenteral drug product manufacturing.

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

• Strong interpersonal skills to work cross-functionally within a team.
• Strong self-management and organizational skills.
• 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

• Not specified beyond degree requirements above.

Additional Requirements

• Role is Monday through Friday based and will be phased from a project support role to a routine support role as the development facility and processes progress. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
• Travel may be required during the project phase for training and implementation of sterility assurance programs.