Job Description

Job Description

Job Description

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.

Position Overview

Located at our large molecule headquarters in RTP, North Carolina, the HSE/Biosafety Officer will lead the charge in managing the RTP Environmental, Health, Safety, and Biosafety programs, ensuring compliance with regulatory requirements and promoting a culture of safety. This role is critical in overseeing biosafety management in a working laboratory where there is frequent handling of biological, chemical, and hazardous waste. The position will manage our new facility for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC. This position will report to the Site Facilities Manager.

Critical Performance Areas

1. Develop and maintain HSE, Biosafety, and Site Safety programs, strategies, and policies to support the organization’s goals in compliance with Federal, State, and Local regulations.
2. Drive and support continuous improvement initiatives for HSE and Biosafety management systems to mitigate risks and enhance safety performance.
3. Coordinate and manage risk management plans for facility use of biological, chemical, and hazardous waste or other biohazards.
4. Lead and manage compliance audits, inspections, and assessments, ensuring corrective actions are implemented and regulatory requirements are met.
5. Promote a culture of safety and responsibility, ensuring consistent communication and collaboration and training across all departments.

Essential Job Functions

• Possess extensive knowledge of HSE and biosafety regulatory frameworks.
• Ensure site-wide compliance with biosafety standards per Federal, State, Local guidelines.
• Conduct risk assessments for projects involving high-risk pathogens ensuring all processes align with best safety practices.
• Serve as primary liaison with all regulatory agencies.
• Lead all investigations involving biological, chemical, or hazardous waste exposure, and oversee development of corrective action plans.
• Lead the Site Safety Committee; facilitating regular meetings, tracking action items, and driving safety initiatives.
• Develop and execute emergency response and preparedness plans for biological, chemical, and physical hazards, to include infectious disease outbreaks, hazardous material spills, or fires.
• Serve as site incident commander during biosafety, hazard, or fire incidents to direct proper response and mitigation actions are taken.
• Lead the remediation of safety incidents and problem areas, ensuring thorough root cause analysis, development of corrective and preventive action plans (CAPAs), timely implementation, and conduct effectiveness checks.
• Track and report on incident trends and recurring safety issues, using data to inform training, procedural updates, and risk mitigation strategies.
• Create and maintain accurate, detailed documentation related to safety protocols, incident reports, risk assessments, and training programs.
• Supervise and mentor direct reports, providing guidance, performance feedback, and professional development opportunities to ensure team alignment with safety goals and regulatory compliance.

Requirements

• B.A/B.S. in Life Sciences in Life Sciences, Environmental Health, Public Health, Occupational Safety or a related field with 10+ years of progressive experience in HSE or Biosafety or equivalent schooling and experience.
• Experience working in a GMP environment.
• Experience and knowledge of NIH, CDC, OSHA, and EPA standards applicable to the life science industry.
• Experience supporting inspections from local, state, and federal authorities.

Other Desired Skills/Abilities

• 3 years in a direct management or leadership role within a life science organization.
• Strong project management skills with ability to prioritize and manage multiple projects in a fast-paced environment.
• Strong decision-making ability: make sound decisions independently and quickly in the best interest of the facility and employee safety.
• Strong written and verbal communication skills.
• Strong analytical skills with the ability to assess risk and present complex safety concepts to leadership and cross-functional teams.
• Trend analysis to anticipate changes in the HSE/Biosafety landscape to stay on top of changing regulations.
• Knowledge of import/export permits and process timelines i.e., CITES, USDA requirements.
• Prior CRO/CMDO experience preferred.
• Prior experience in a startup preferred.

Reporting Structure

This job typically reports to:

• Facilities Manager

NOTE : This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

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