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 execution is required
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
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