Sr Specialist – Biosafety and Biotechnology Solutions
| Company | Inventing for Life |
|---|---|
| Location | Papillion, NE, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in Microbiology, Public Health, Occupational Health and Safety, Engineering (general, chemical, biological, biochemical) or a related field.
- 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.
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.
- Conduct biosafety program reviews and corrective and preventive action plan development 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.
- 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.
Preferred Qualifications
- Master’s degree in a related discipline is 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.