Sr. Specialist Biosafety

Sr. Specialist, Biosafety

The Sr. Specialist of Biosafety is accountable for providing and managing an efficient and effective Biosafety program at the Millsboro, Delaware Animal Health site. The successful candidate will play a key role in developing, implementing, and maintaining biosafety programs and policies to ensure a safe working environment in compliance with local, state, and federal regulations. The Sr. Specalist of Biosafety will collaborate with various departments to promote best practices in biosafety and manage risk assessments related to small scale biological activities, large scale vaccine manufacture, and animal studies.

This position sits within the Global Safety & Environment organization, and reports to the Associate Director of Safety & Environment at Millsboro, DE.

Responsibilities:

• Ensure compliance with internal and external biosafety regulations and guidelines established by organizations such as the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Occupational Safety and Health Administration (OSHA).
• Maintain up-to-date knowledge of federal, state, and local biosafety regulations, and advise management accordingly.
• Review risk assessments for biological materials and laboratory operations to identify potential biohazards.
• Facilitate the safe handling of biological agents and materials from Risk Group 1 through Risk Group 3 at for small and large scale operations and animal testing; evaluate and support verification testing of risk mitigating controls
• Develop strategies and protocols to mitigate identified risks, including the selection of appropriate biosafety levels for work.
• Develop and deliver training programs for staff on biosafety practices, laboratory safety procedures, and emergency response protocols.
• Create educational materials and resources to enhance biosafety awareness and practices among laboratory personnel.
• Develop, review, and update biosafety policies and standard operating procedures (SOPs) for the safe handling of biological materials.
• Collaborate with institutional biosafety committees (IBC) to review protocols and ensure adherence to biosafety standards.
• Investigate biosafety/biosecurity incidents, including exposure and spill events, and develop corrective actions to prevent recurrence.
• Maintain records of incidents and ensure proper reporting to relevant regulatory authorities as required.
• Conduct regular inspections of laboratories and facilities to ensure compliance with biosafety standards and practices.
• Prepare for and facilitate internal or external audits and inspections related to biosafety.
• Collaborate with other departments and stakeholders to promote a culture of safety and biosafety awareness throughout the organization.
• Provide expert consultation on biosafety matters to support research and development initiatives.

Education:

• Bachelor’s degree in Microbiology, Public Health, Occupational Health and Safety, or a related field
• Certified Biological Safety Professional (CBSP) or equivalent is highly desirable
• Master’s degree in related discipline is also preferred

Skills

• Strong knowledge of biosafety regulations and best practices.
• Develop, implement, and maintain biosafety and biosecurity governance programs, biological risk assessments, and training programs
• Proficiency in laboratory practices, including the handling of pathogens and hazardous materials in various settings
• Excellent analytical, problem-solving, and decision-making skills.
• Ability to effectively manage multiple projects and prioritize tasks for efficient and successful outcomes
• Strong communication skills, both written and verbal, with the ability to convey complex information clearly to diverse audiences.
• Ability to work independently and as part of a multidisciplinary team.

Experience:

Required

• Minimum of 5 years of experience in biosafety, biosecurity, or related fields, with demonstrated expertise in laboratory safety and risk assessment.
• Proven experience in developing, maintaining, and sustaining a comprehensive biosafety program, including the creation of policies, procedures, and training initiatives.

Preferred

• Strong written and oral communication skills