Fujifilm
Associate Director, Corporate Biosafety Officer
Fujifilm, Salt Lake City, Utah, United States, 84193
Fujifilm Associate Director, Corporate Biosafety Officer Salt Lake City, Utah Apply Now
As the Associate Director of Biosafety, you will serve as the Corporate Biosafety Officer (BSO) and provide expertise in biorisk management, specifically, biohazard identification and product handling risk assessment across global sites, ensuring safe laboratory and manufacturing work practices as well as product quality and safety. This position will report to the Global Director, Biosafety and Toxicology, and sit under the global quality leadership group (Regulatory, IT, Safety, QA, and QC).Main Activities and Responsibilities:Contribute to the advancement of biosafety awareness and set EHS team priorities including biosafety, laboratory safety, and product handling risk assessments.Assist in coordinating the global biosafety network; maintain appropriate network membership, coordinate/manage a regular meeting cadence and drive network objectives.Provide a framework for robust, scientifically-sound risk health hazard assessments for employees handling proprietary and non-proprietary biomolecules used in the production of medicinal products in the workplace and biosafety assessments.Review and approve assessments (rDNA, GMO), support site level subject matter experts to drive risk assessment processes.Update and revise procedures and guidelines related to biosafety and health hazard assessment.Assist in revising and/or developing cross functional assessment methodologies for early clinical stage projects, specifically cell and viral gene therapies.Serve as a corporate biosafety subject matter expert; maintain awareness of advances in biotechnology and new modalities for targets in drug discovery to determine appropriate handling assessments and controls.Oversee all biosafety related training globally and assist in content creation, execution, and metrics generation for continuous improvement initiatives.Collaborate with EHS, Quality, Regulatory, Operations, Process Development, and Engineering groups as part of comprehensive occupational hazard evaluation, control and risk assessment.Develop and establish a global biosafety standard that aligns with ISO35001, biosafety regulatory requirements (US/EU), and industry best practices.Maintain the Biological Safety Standard; develop/maintain supporting documented management systems and tools to support implementation.Collaborate with site EHS team colleagues to establish common assessment tools to characterize biosafety risks associated with operations and to enable prioritization of program development and risk management actions.Background Requirements and Education:PhD in life sciences with a concentration in biological sciences preferred (microbiology, medical laboratory science, biology, molecular biology, etc) with 8+ years’ proven experience in bio-risk management or an equivalency of professional training, certifications, and related work experience, ORA Master’s degree in life sciences with a concentration in biological sciences preferred (microbiology, medical laboratory science, biology, molecular biology, etc.) with 10+ years’ proven experience in a bio-risk management or an equivalency of professional training, certifications, and related work experience.Strong understanding of GMP principles and working within a quality centric organization requiring compliance with international drug manufacturing authorities (FDA, EMA, MHRA, DMA).Proven experience as a biosafety officer in GMP environments handling recombinant mammalian, microbial, and cell & viral gene therapies.Technical subject matter expertise in viral gene therapies (VGTs), infectious biological agents, and current good manufacturing practices (cGMP).Experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry.Advanced knowledge of best biosafety practices according to federal and international guidelines.Excellent written and verbal communication skills as well as proven negotiation, collaboration, and interpersonal leadership skills.Ability to travel up to 25%.Desired Skillset:Proven proficiency in technical science writing, specifically regarding risk assessments is desired.Professional certification or ability to obtain professional certification in biological safety from an internationally recognized organization: ABSA, Certified Biological Safety Professional (CBSP), ABSA, Registered Bio-Safety Professional (RBP), IFBA, Certified Professional – Biorisk Management (CP-IFBA).Willingness to pursue professional development and/or continuing education opportunities to maintain proficiency with emerging technologies, market trends, and best practices for biological risk management.The US salary range for this position is $155,000 to $201,000. Pay within this range varies by work location and may also depend on job-related knowledge, skills, and experience.FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity or any other protected class.
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As the Associate Director of Biosafety, you will serve as the Corporate Biosafety Officer (BSO) and provide expertise in biorisk management, specifically, biohazard identification and product handling risk assessment across global sites, ensuring safe laboratory and manufacturing work practices as well as product quality and safety. This position will report to the Global Director, Biosafety and Toxicology, and sit under the global quality leadership group (Regulatory, IT, Safety, QA, and QC).Main Activities and Responsibilities:Contribute to the advancement of biosafety awareness and set EHS team priorities including biosafety, laboratory safety, and product handling risk assessments.Assist in coordinating the global biosafety network; maintain appropriate network membership, coordinate/manage a regular meeting cadence and drive network objectives.Provide a framework for robust, scientifically-sound risk health hazard assessments for employees handling proprietary and non-proprietary biomolecules used in the production of medicinal products in the workplace and biosafety assessments.Review and approve assessments (rDNA, GMO), support site level subject matter experts to drive risk assessment processes.Update and revise procedures and guidelines related to biosafety and health hazard assessment.Assist in revising and/or developing cross functional assessment methodologies for early clinical stage projects, specifically cell and viral gene therapies.Serve as a corporate biosafety subject matter expert; maintain awareness of advances in biotechnology and new modalities for targets in drug discovery to determine appropriate handling assessments and controls.Oversee all biosafety related training globally and assist in content creation, execution, and metrics generation for continuous improvement initiatives.Collaborate with EHS, Quality, Regulatory, Operations, Process Development, and Engineering groups as part of comprehensive occupational hazard evaluation, control and risk assessment.Develop and establish a global biosafety standard that aligns with ISO35001, biosafety regulatory requirements (US/EU), and industry best practices.Maintain the Biological Safety Standard; develop/maintain supporting documented management systems and tools to support implementation.Collaborate with site EHS team colleagues to establish common assessment tools to characterize biosafety risks associated with operations and to enable prioritization of program development and risk management actions.Background Requirements and Education:PhD in life sciences with a concentration in biological sciences preferred (microbiology, medical laboratory science, biology, molecular biology, etc) with 8+ years’ proven experience in bio-risk management or an equivalency of professional training, certifications, and related work experience, ORA Master’s degree in life sciences with a concentration in biological sciences preferred (microbiology, medical laboratory science, biology, molecular biology, etc.) with 10+ years’ proven experience in a bio-risk management or an equivalency of professional training, certifications, and related work experience.Strong understanding of GMP principles and working within a quality centric organization requiring compliance with international drug manufacturing authorities (FDA, EMA, MHRA, DMA).Proven experience as a biosafety officer in GMP environments handling recombinant mammalian, microbial, and cell & viral gene therapies.Technical subject matter expertise in viral gene therapies (VGTs), infectious biological agents, and current good manufacturing practices (cGMP).Experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry.Advanced knowledge of best biosafety practices according to federal and international guidelines.Excellent written and verbal communication skills as well as proven negotiation, collaboration, and interpersonal leadership skills.Ability to travel up to 25%.Desired Skillset:Proven proficiency in technical science writing, specifically regarding risk assessments is desired.Professional certification or ability to obtain professional certification in biological safety from an internationally recognized organization: ABSA, Certified Biological Safety Professional (CBSP), ABSA, Registered Bio-Safety Professional (RBP), IFBA, Certified Professional – Biorisk Management (CP-IFBA).Willingness to pursue professional development and/or continuing education opportunities to maintain proficiency with emerging technologies, market trends, and best practices for biological risk management.The US salary range for this position is $155,000 to $201,000. Pay within this range varies by work location and may also depend on job-related knowledge, skills, and experience.FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity or any other protected class.
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