Sr. Specialist, Biosafety and Biotechnology Solutions

The Sr. Specialist in Biosafety and Biotechnology Solutions is responsible for managing an effective biosafety program while supporting production troubleshooting, vaccine process development, and key business initiatives at the Elkhorn Animal Health site. This role will ensure compliance with biosafety regulations and promote best practices across various departments, fostering a culture of safety and continuous improvement.

 Reporting Structure

This position sits within the Global Safety & Environment organization and reports to the Director of Environment, Health & Safety at Elkhorn, NE; while also collaborating closely with the Director of Biotechnology Solutions.

Key Responsibilities

Biosafety Management:

• Develop, implement, and maintain biosafety programs and policies in compliance with local, state, and federal regulations (CDC, NIH, OSHA, WHO).
• Review and conduct risk assessments for biological materials and laboratory operations to identify potential biohazards.
• Facilitate the safe handling of biological agents Biosafety Level 2+ for small and large-scale operations and animal testing.
• Develop/update  and deliver training programs on biosafety practices, laboratory safety procedures, and emergency response protocols.
• Investigate biosafety incidents and develop corrective actions to prevent recurrence, maintaining records and ensuring proper reporting to regulatory authorities.
• Conduct biosafety program reviews and corrective and preventive action plan development for the site. These include Biosafety SOPs, gap assessments against Company standards and regulatory requirements, program assessments with Senior Leadership, Farm Contingency Plan, etc.)
• Biotechnology Solutions Support:
• Lead production investigations and support daily technical activities within production, implementing process improvements.
• Collaborate with departments such as Quality, Environmental Health and Safety, Technical Support, Planning, and Maintenance to ensure alignment of goals.
• Provide guidance on product impact from technical or compliance deviations with minimal supervision.
• Understand and lead process development capabilities within the Biotechnology Solutions development lab.

Collaboration and Culture:

• Create an open culture of learning, acceptance, and respect within the team and across departments.
• Promote a culture of safety and biosafety awareness throughout the organization.
• Prepare for and facilitate external audits and inspections related to biosafety and biotechnology processes.

Qualifications

Education

• Bachelor’s degree in Microbiology, Public Health, Occupational Health and Safety, Engineering (general, chemical, biological, biochemical) or a related field.
• Master’s degree in a related discipline is preferred.

Experience

Required:

• Minimum of 5 years of experience in biosafety, biosecurity, or related fields, with demonstrated expertise in laboratory safety and risk assessment.
• Minimum of 2 years of laboratory or related vaccine production experience in an academic, FDA, or USDA-regulated setting.

Preferred:

• Prior experience supporting an FDA or USDA-regulated manufacturing environment.
• Certified Biological Safety Professional (CBSP) or equivalent; desirable but not required based on experience combined with education.
• Experience with vaccine or large molecule process development.
• Lean and Six Sigma skills.
• Statistical math skills using Minitab.

Skills

• Strong knowledge of biosafety regulations and best practices.
• Excellent analytical, problem-solving, and decision-making skills.
• 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.
• Enthusiasm for continuous learning and imparting knowledge to others.