Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing

Role Summary

Sterility Assurance – Technical Services/Manufacturing Scientist (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies. Primary objectives include the start-up and compliant manufacturing of gene therapy drug product and drug substance, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management.

Responsibilities

• Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, sanitization, and sterilization.
• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination
• Provide technical support on cleaning deviations/events and assist in root cause analysis.
• Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
• Ensure site‚Äôs environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level
• Provide technical guidance to the Process Team for sterility assurance programs
• Lead or provide technical support for root cause investigations related to sterility assurance programs
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements
• Perform periodic review of environmental monitoring data
• Lead or support risk assessments related to sterility assurance programs
• Create, execute, review, and/or approve technical documents related to sterility assurance programs
• Create, execute, and/or evaluate change controls related to sterility assurance programs
• Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends
• Participate in continuous improvement projects to improve quality performance at the site
• Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed
• Serve as cleaning/sterility assurance interface external to the LP2 site
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Qualifications

• Bachelors in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• 1+ year of experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, TS/MS, quality assurance, etc.)

Additional Preferences

• In depth knowledge of gene therapy drug product manufacturing
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Strong oral and written communication skills that demonstrate an 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