Lilly
Principal Scientist - Sterility Assurance Lead
Lilly, Pleasant Prairie, Wisconsin, United States, 53158
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Responsibilities:
The Principal Scientist – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership regarding sterility assurance strategies.
Primary objectives include developing a team to support the compliant manufacturing of Lilly Kenosha County products, 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. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the Lilly Kenosha County site.
Key Objectives/Deliverables:
Provide leadership to TS/MS organization for technical and administrative issues.
Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
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.
Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk.
Provide technical support for all start-up activities related to sterility assurance programs (e.g., airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
Ensure site’s 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 and 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.
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
Serve as sterility assurance interface external to the Lilly Kenosha County 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.
Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Basic Qualifications:
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
Prior experience in cross functional technical leadership roles.
In-depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance.
5+ years supporting cGMP manufacturing preferred (specifically within operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.).
Additional Skills/Preferences:
Strong interpersonal and teamwork skills.
Strong self-management and organizational skills.
Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) 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.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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Responsibilities:
The Principal Scientist – Sterility Assurance – Technical Services/Manufacturing Science (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership regarding sterility assurance strategies.
Primary objectives include developing a team to support the compliant manufacturing of Lilly Kenosha County products, 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. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the Lilly Kenosha County site.
Key Objectives/Deliverables:
Provide leadership to TS/MS organization for technical and administrative issues.
Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
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.
Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk.
Provide technical support for all start-up activities related to sterility assurance programs (e.g., airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
Ensure site’s 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 and 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.
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
Serve as sterility assurance interface external to the Lilly Kenosha County 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.
Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Basic Qualifications:
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
Prior experience in cross functional technical leadership roles.
In-depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance.
5+ years supporting cGMP manufacturing preferred (specifically within operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.).
Additional Skills/Preferences:
Strong interpersonal and teamwork skills.
Strong self-management and organizational skills.
Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) 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.
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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