Health, Safety, and Environmental (HSE) Lead

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The HSE Lead is responsible for managing HSE programs, ensuring compliance and driving continuous improvement in a cell and gene therapy biomanufacturing environment. The HSE Lead plays a key role in the operations of Genezen by promoting a safety and continuous improvement culture across all levels of the organization.

ESSENTIAL JOB FUNCTIONS

• Develop and manage HSE programs including but not limited to emergency preparation (CPR/first aid, spill response), chemical hygiene, biosafety plan, contractor safety, bloodborne pathogens, industrial hygiene, hazardous waste management and wastewater treatment
• Evaluate facility HSE conditions, assess risks, and develop appropriate corrective-action plans and budgets to make improvements
• Facilitate HSE related risk assessments as they pertain to new equipment or process introduction, ensuring the proper hazard assessment and risk mitigation
• Maintain HSE leading indicator reporting through proactive engagement and analysis. Maintain incident and injury record reporting system
• Manage vendor programs including hazardous waste & biological waste management and pest control
• Coordinate and deploy formal and informal HSE training. Includes both external training vendors and/or develop internal training.
• Serve as site Emergency Coordinator for incidents, personnel injury or fire response. Implement and drive meaningful corrective actions to prevent future occurrences.
• Manage municipal, state, and federal permitting requirements for a biological manufacturing facility
• Represent Genezen during applicable regulatory or client audits and inspections
• Manage annual HSE budget
• Supports site continuous improvement initiatives through use of continuous improvement tools, templates, dashboards and internal communications
• Supports visual daily management (Tier meeting), including development of leading indicators
• Leads proactive-learning activities such as After Action Reviews, cross-functional workshops, and kaizen events

SPECIAL JOB REQUIREMENTS

• Experience with Lab Safety and/or Biosafety
• Working knowledge of government regulations and industry standards, including OSHA, EPA, DOT, RCRA, NFPPA
• Proficiency in MS Office including Word, Excel, and PowerPoint
• Skills in data visualization (Power BI, Power Query, PowerApps)
• Experience with quality system compliance
• Interest in human factors & system safety (aka human & organizational performance)
• Ability to travel domestically (5%)

KNOWLEDGE, SKILLS AND EXPERIENCE

• Bachelor’s Degree in Occupational Health/Safety, Engineering or related field
• 5-7 years related work experience
• Experience working in biopharmaceutical manufacturing facility
• Experience working in a lab safety environment
• Thorough knowledge of federal and local EHS regulations including OSHA and EPA
• Lab Safety & Biosafety experience, such as professional course work or work towards a Registered Biosafety Professional Certificate
• Lean/Continuous Improvement certification or professional level coursework (Yellow Belt)
• Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
• ESG reporting experience

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Occasionally required to work in a GMP clean room environment with personal protective equipment/aseptic gowning
• Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities
• Spending time on the floor during activity