Associate Director, Corporate Biosafety Officer

Overview:

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).

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow’s medicines – our Genki – will always be our driving force. Whilst working as the Associate Director of Biosafety in our global Quality team, you’ll be joining other motivated individuals who fuel one another’s passions and embrace every day as an opportunity. We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. As we grow our community, our capacity, and capabilities significantly in the next 5 years, we’re looking for passionate people to join our global team. This is a global position that will support all sites (Denmark, United Kingdom, Texas, California, and North Carolina).

You will help establish consistent biosafety and product containment practices within the constraints of current facility operating practices and engineering controls, oversee permitting processes for biological materials for all locations (e.g. CDC, USDA, EU, FDA, etc.), address sustainability issues with regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety audits, and represent FDB as a biosafety subject matter expert. This role will have 7-10 direct and indirect reports.

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, OR
• 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 a bio-risk management or an equivalency of professional training, certifications, and related work experience.
• Strong understanding of GMP principals 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 corporate BSO will be involved with nearly every aspect of the business as a centralized subject matter expert (SME) that can assist in commercial (sales, feasibility/fit), program design (RFI/RFP), program management (new product introductions), PD (risk assessments), MFG, Quality, EHS, Regulatory, Compliance, technical marketing, and training verticals. This position will interface with clients (as necessary for audits, inspections, site visits, and conference/booth responsibilities) and serve as the corporate SME for all biosafety and biosecurity functions internally and externally (conference presentations, seminars, webinars, teaching engagements, technical marketing, etc).

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.

As part of any recruitment process, FUJIFILM Diosynth Biotechnologies collects and processes personal data relating to job applicants. The organization is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark; Teesside, UK; RTP, North Carolina; Holly Springs, North Carolina; College Station, Texas; and Thousand Oaks, California. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.  ​​

FDBU 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 identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.