BioSpace
Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing
BioSpace, Lebanon, Indiana, United States, 46052
Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing
Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship. Job Description
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. Key Objectives/Deliverables
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. 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 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 Basic Requirements
Bachelors in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline 1+ year of experience supporting cGMP manufacturing 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship. Job Description
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. Key Objectives/Deliverables
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. 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 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 Basic Requirements
Bachelors in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline 1+ year of experience supporting cGMP manufacturing 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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