The company is looking to manage an effective biosafety program and support production troubleshooting, vaccine process development, and key business initiatives at the Elkhorn Animal Health site.
Requirements
- Strong knowledge of biosafety regulations and best practices.
- Experience with vaccine or large molecule process development.
- Lean and Six Sigma skills.
- Statistical math skills using Minitab.
- Certified Biological Safety Professional (CBSP) or equivalent; desirable but not required based on experience combined with education.
- Prior experience supporting an FDA or USDA-regulated manufacturing environment.
- Minimum of 5 years of experience in biosafety, biosecurity, or related fields, with demonstrated expertise in laboratory safety and risk assessment.
Responsibilities
- 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.
- 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.
Other
- 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.
- Minimum of 2 years of laboratory or related vaccine production experience in an academic, FDA, or USDA-regulated setting.
- 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.
- Travel Requirements: 10%
- Valid Driving License: No
- Hazardous Material(s): n/a
