Associate Director, Corporate Biosafety Officer

$155,000 - $201,000/Yr

Fujifilm - Boston, MA

Full-time - Senior

Boston, MA

Machinery Manufacturing

About the position

The Associate Director of Biosafety will act as the Corporate Biosafety Officer, providing expertise in biorisk management, biohazard identification, and product handling risk assessment across global sites. This role ensures safe laboratory and manufacturing practices while maintaining product quality and safety. The position is part of the global quality leadership group and reports to the Global Director of Biosafety and Toxicology.

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.
• 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.
• 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.

Requirements

• 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.
• A 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 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.

Nice-to-haves

• 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.

Benefits

• Competitive salary range of $155,000 to $201,000 based on experience and location.
• Opportunities for professional development and continuing education.
• Collaborative and innovative work environment.
• Diverse and inclusive workplace culture.