Merck
Sr. Specialist in 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. This position is 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 include: Develop, implement, and maintain biosafety programs and policies in compliance with local, state, and federal regulations. Review and conduct risk assessments for biological materials and laboratory operations. Facilitate the safe handling of biological agents from Risk Group 1 through Risk Group 3 for small and large-scale operations and animal testing. Develop 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 for the site. 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. Understand and lead tech transfer. 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. Education: Bachelor's degree in Microbiology, Public Health, Occupational Health, Safety, Engineering, or a related field. Master's degree in a related discipline is preferred. Certified Biological Safety Professional (CBSP) or equivalent is highly desirable. Experience: Required:
Minimum of 5 years of experience in biosafety, biosecurity, or related fields, with demonstrated expertise in laboratory safety and risk assessment. Required:
Minimum of 3 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. Preferred:
Experience with vaccine or large molecule process development.
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. This position is 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 include: Develop, implement, and maintain biosafety programs and policies in compliance with local, state, and federal regulations. Review and conduct risk assessments for biological materials and laboratory operations. Facilitate the safe handling of biological agents from Risk Group 1 through Risk Group 3 for small and large-scale operations and animal testing. Develop 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 for the site. 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. Understand and lead tech transfer. 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. Education: Bachelor's degree in Microbiology, Public Health, Occupational Health, Safety, Engineering, or a related field. Master's degree in a related discipline is preferred. Certified Biological Safety Professional (CBSP) or equivalent is highly desirable. Experience: Required:
Minimum of 5 years of experience in biosafety, biosecurity, or related fields, with demonstrated expertise in laboratory safety and risk assessment. Required:
Minimum of 3 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. Preferred:
Experience with vaccine or large molecule process development.