Associate Director Sterility Assurance
BioSpace, Virginia State University, VA, United States
Associate Director – Sterility Assurance
Civica is searching for an Associate Director – Sterility Assurance to support the growth and operational readiness of its Petersburg, VA facility, which will be the first generic drug product facility in the U.S. to use all isolator‑style high‑speed filling lines. The individual will serve as a site‑level technical leader responsible for establishing, executing, and continuously improving sterility assurance control strategies that underpin Civica's aseptic manufacturing operations, including the Civica Affordable Insulin program.
Essential Duties And Responsibilities
The essential functions include, but are not limited to the following:
Establish, implement, and continuously improve site‑level sterility assurance control strategies, including environmental monitoring, contamination control, personnel qualification, and aseptic process simulation programs, in alignment with cGMP regulations and current industry guidance (e.g., USP, EU Annex 1, FDA Aseptic Processing Guidance).
Serve as the primary site Subject Matter Expert (SME) for sterility assurance, providing technical guidance to Manufacturing, Quality, and Engineering functions on matters related to aseptic operations, contamination control, and microbiological risk management.
Lead and support microbiological and sterility assurance investigations, including OOS/OOT results, environmental monitoring excursions, and media fill failures, driving thorough root cause analysis and the development of effective CAPAs.
Support the design, qualification, and start‑up of aseptic filling lines and associated barrier systems (isolators), ensuring sterility assurance requirements are incorporated into facility and equipment design from the outset.
Develop, author, and review GMP documentation including SOPs, validation protocols, technical reports, contamination control strategies, and risk assessments in support of site operations and regulatory submissions.
Lead and coordinate Aseptic Process Simulation (media fill) programs, including design, execution, evaluation, and trending of results.
Contribute to the design, development and monitoring of the site Environmental Monitoring program, including data trending, alert/action limit setting, and program effectiveness reviews.
Support regulatory inspection readiness and participate in health authority inspections (e.g., FDA) as the site SME for sterility assurance, preparing relevant documentation and responses.
Participate in external industry forums, technical conferences, and regulatory working groups to stay current with emerging guidance and best practices in sterility assurance, bringing relevant learnings back to the site.
Build and develop site‑level sterility assurance capability by mentoring, training and providing technical guidance to junior scientists and cross‑functional team members.
Collaborate with network and corporate technical functions to ensure site programs are aligned with broader organizational standards and best practices, while maintaining a primary focus on Petersburg site needs.
Maintain a safe work environment and support all applicable Health, Safety, and Environmental (HSE) goals and requirements.
Basic Qualifications (knowledge, Skills, And Abilities)
Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, or a related discipline required.
Master's degree or PhD in a biological science preferred.
Minimum 10+ years of experience in parenteral sterility assurance, environmental monitoring, or equivalent roles within a highly regulated pharmaceutical manufacturing environment.
Deep technical knowledge of sterility assurance science and compliance, including current regulatory expectations for aseptic processing, contamination control, and environmental monitoring.
Hands‑on experience with isolator or RABS barrier system technology in a parenteral manufacturing setting.
Demonstrated ability to lead microbiological investigations, perform root cause analysis, and develop effective corrective and preventive actions.
Strong working knowledge of applicable regulatory guidance including FDA Aseptic Processing Guidance, EUGMP Annex 1, and relevant USP chapters.
Excellent written and oral communication skills, with the ability to present complex technical topics to cross‑functional teams and regulatory agencies.
Strong data analysis skills, attention to detail, and ability to make sound technical decisions in a dynamic manufacturing environment.
Ability to mentor and develop scientific talent in the field of sterility assurance and applied pharmaceutical microbiology.
Demonstrated ability to work cross‑functionally and influence peers and stakeholders to advance technical and quality objectives.
Preferred Qualifications
Experience supporting greenfield or new facility start‑up activities, including the establishment of sterility assurance programs from the ground up.
Familiarity with high‑speed aseptic filling operations and isolator‑based manufacturing environments.
Experience participating in FDA or other health authority inspections as a sterility assurance SME.
Exposure to Annex 1 (2022) implementation and contamination control strategy development.
Experience working in or alongside a network technical function or supporting multi‑site sterility assurance program harmonization.
PHYSICAL DEMANDS AND WORK ENVIRONMENT The employee is regularly required to talk and hear. The employee is frequently required to use hands or fingers and handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
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Essential Duties And Responsibilities
The essential functions include, but are not limited to the following:
Establish, implement, and continuously improve site‑level sterility assurance control strategies, including environmental monitoring, contamination control, personnel qualification, and aseptic process simulation programs, in alignment with cGMP regulations and current industry guidance (e.g., USP, EU Annex 1, FDA Aseptic Processing Guidance).
Serve as the primary site Subject Matter Expert (SME) for sterility assurance, providing technical guidance to Manufacturing, Quality, and Engineering functions on matters related to aseptic operations, contamination control, and microbiological risk management.
Lead and support microbiological and sterility assurance investigations, including OOS/OOT results, environmental monitoring excursions, and media fill failures, driving thorough root cause analysis and the development of effective CAPAs.
Support the design, qualification, and start‑up of aseptic filling lines and associated barrier systems (isolators), ensuring sterility assurance requirements are incorporated into facility and equipment design from the outset.
Develop, author, and review GMP documentation including SOPs, validation protocols, technical reports, contamination control strategies, and risk assessments in support of site operations and regulatory submissions.
Lead and coordinate Aseptic Process Simulation (media fill) programs, including design, execution, evaluation, and trending of results.
Contribute to the design, development and monitoring of the site Environmental Monitoring program, including data trending, alert/action limit setting, and program effectiveness reviews.
Support regulatory inspection readiness and participate in health authority inspections (e.g., FDA) as the site SME for sterility assurance, preparing relevant documentation and responses.
Participate in external industry forums, technical conferences, and regulatory working groups to stay current with emerging guidance and best practices in sterility assurance, bringing relevant learnings back to the site.
Build and develop site‑level sterility assurance capability by mentoring, training and providing technical guidance to junior scientists and cross‑functional team members.
Collaborate with network and corporate technical functions to ensure site programs are aligned with broader organizational standards and best practices, while maintaining a primary focus on Petersburg site needs.
Maintain a safe work environment and support all applicable Health, Safety, and Environmental (HSE) goals and requirements.
Basic Qualifications (knowledge, Skills, And Abilities)
Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, or a related discipline required.
Master's degree or PhD in a biological science preferred.
Minimum 10+ years of experience in parenteral sterility assurance, environmental monitoring, or equivalent roles within a highly regulated pharmaceutical manufacturing environment.
Deep technical knowledge of sterility assurance science and compliance, including current regulatory expectations for aseptic processing, contamination control, and environmental monitoring.
Hands‑on experience with isolator or RABS barrier system technology in a parenteral manufacturing setting.
Demonstrated ability to lead microbiological investigations, perform root cause analysis, and develop effective corrective and preventive actions.
Strong working knowledge of applicable regulatory guidance including FDA Aseptic Processing Guidance, EUGMP Annex 1, and relevant USP chapters.
Excellent written and oral communication skills, with the ability to present complex technical topics to cross‑functional teams and regulatory agencies.
Strong data analysis skills, attention to detail, and ability to make sound technical decisions in a dynamic manufacturing environment.
Ability to mentor and develop scientific talent in the field of sterility assurance and applied pharmaceutical microbiology.
Demonstrated ability to work cross‑functionally and influence peers and stakeholders to advance technical and quality objectives.
Preferred Qualifications
Experience supporting greenfield or new facility start‑up activities, including the establishment of sterility assurance programs from the ground up.
Familiarity with high‑speed aseptic filling operations and isolator‑based manufacturing environments.
Experience participating in FDA or other health authority inspections as a sterility assurance SME.
Exposure to Annex 1 (2022) implementation and contamination control strategy development.
Experience working in or alongside a network technical function or supporting multi‑site sterility assurance program harmonization.
PHYSICAL DEMANDS AND WORK ENVIRONMENT The employee is regularly required to talk and hear. The employee is frequently required to use hands or fingers and handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
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