Sr. Manager of Environment, Health, Safety and Security
Operations: Facilities and Site Engineering | Research Triangle Park, NC | Full Time
Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.
Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.
The Sr. Manager of Environment, Health, Safety and Security is responsible for the development and implementation of EHS&S programs in a newly retrofitted bioprocessing facility. The position is accountable to provide strategic input into policies, standards operating procedures (SOP) and operational processes to deliver fit-for-purpose, reliable, compliant, and cost effective EHS&S Culture. The position is accountable for achieving business objectives ensuring the safe operations by company employees, costs are contained, and work is performed in a manner that is compliant with governing regulations and cGMP practices. These responsibilities include, but are not limited to:
- Support the Executive Director, Facilities & Site Engineering
- Accountable for the development, training, and implementation oversight of all aspects of the EHS&S programs. Lead the development of EHS&S policies, SOPs, operating programs, and training requirements. Accountable for the development, implementation, and continuous success of EHS&S Councils and Committees and ultimately responsible for the implementation of a successful EHS&S Culture.
- Drive the development, implementation and monitor the performance of industrial EHS&S programs such as: environmental permitting, industrial waste disposal, risk management, and capital project EHS&S review and oversight, ancillary employee safety programs, auditing of site and third-party contractors procedures, contractor prequalification, contractor training, driver/vehicle safety, emergency management and incident response, equipment safety, fire safety, life safety systems, powered industrial trucks, pressure systems, records management, waste management, and work permitting.
- Interface with other functions across the company to ensure integration of EHS&S in all activities. Maintain records of activities and procedures to comply with all legal requirements. Assist in the development of documentation, including functional requirements, design documents, test protocols, SOPs and reports from the EHS&S perspective
- Assure all facilities, maintenance, R&D and bioproduction operations are run in a safe manner and comply with all EHS&S policies, standards and regulations. Provide EHS&S support and guidance to ensure compliance with EHS&S Policies and Standards, local, state and federal EHS&S regulations while maintaining flexibility for the operation and maintenance of R&D and bioproduction areas as needed. Develop and provide practical EHS&S training to managers and employees to enable them to deliver on related EHS&S accountabilities. Monitor and report on EHS&S performance and the effectiveness of site EHS&S management systems to drive improvement.
- Lead industrial safety incident investigations and perform root cause analyses (RCA) as needed. Prepare effective RCA and shared-learning communication documents. Develop and provide practical RCA training to managers and employees to enable them to deliver related EHS&S accountabilities. Development of an EHS&S five-year strategy based on the site risk profile. Own and manage relevant EHS&S risk in a Risk Management Information System tool, if appropriate. Identify, develop and lead the implementation of relevant EHS&S procedures and improvement programs.
- Develop and implement a EHS&S auditing programs across the company, including internal and external (3rd party contracted) operations. Plan, implement, monitor and review the corrective and preventive measures identified as necessary to ensure HSE&S compliance and to minimize operational losses, occupational health problems, ergonomic compliance, accidents and injuries, and security threats.
- Responsibility for containment and disposition of all laboratory and bioproduction waste. Advise and manage the safe disposal of hazardous waste as required. Compile and submit TIER II Report. Manage all aspects of Petroleum Spill Prevention Control and Countermeasures Plan. Implement site waste minimization plan and energy conservation.
- Support the safe installation, commissioning, qualification, and validation of facility and utilities systems for commercial bioprocessing. Assist all company stakeholders, such as facilities, engineering, research, process development and commercial bioprocessing as necessary. Work closely with vendors and contractors to provide services as needed.
- Support during regulatory inspections as the subject matter expert for EHS&S and support regulatory filings as required
- Responsible for the compliance with federal, state, and local regulatory authorities including FDA, EMA, OSHA, EPA, of the Facilities, Utilities and Maintenance Operations.
- Bachelors or master’s Degree in occupational safety engineering, industrial hygiene, or related degree.
- Experience (7-10 years) in an EHS&S management role, with demonstrated experience and expertise in developing industrial hygiene, environmental, safety and security programs in Research and Development, Biological or Chemical manufacturing settings.
- EHS Certification in ASP, CSP, CEP, CHMM, or CIH preferred. Working knowledge of ISO 14001/OHSAS 18001/ANSI Z10.
- Training and experience in incident command, emergency response, HAZMAT, first aid, or other relevant EHS topics.
- Experience in working in a GMP environment is required.
- Experience with capital projects helpful
- Strong working knowledge of core occupational safety, environmental protection, and security programs, OSHA, EPA, and State environmental regulations, standards, permit requirements, and associated compliance obligations is desired.
- Critical and factual analytical thinker
- Able to develop and implement multilevel EHS&S Risk Assessments, identify operational gaps, prioritize, track and implement corrective actions in a timely manner, and manage changes in ways of working.
- Strong oral and written communication skills. Capable of writing management level reports and summaries. Clearly communicates EHS&S and process issues with co-workers and supervision and communicates in a timely manner.
- Ability to summarize and present key performance indicators (KPIs) in practical and understandable formats
- Experience with the preparation of reports and/or presentations and communications via presentation tools such as PowerPoint, narratives, KPIs dashboards, etc.
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment - ability to navigate cross functionally.
- Meeting management / facilitation skills / teamwork and team building skills.
- Ability to multi-task and manage multiple projects.
Budget and financials
- Effectively manages EHS&S operating budgets; effectively and regularly communicates status to the management team.
- Understanding and potential proficiency in project management principles.
- Understanding of the impact EHS&S decisions can have in the operational budgets of other departments
- Demonstrated experience in the development and operation of EHS&S programs in biotech research, product development and bioprocessing operations.
- Demonstrated ability to provide expert EHS&S knowledge to develop, inspire and establish a culture of EHS&S excellence through implementation of key EHS&S management systems.
- Talent to communicate and motivate. Ability to develop rapport, trust and engagement with stakeholders. Proven focus on continuous improvement, and stakeholder engagement, to ensure a positive EHS&S culture. Ability to develop and lead pragmatic solutions, which simultaneously enable business and EHS&S objectives.
- Experience applying EHS&S expertise by working with a diverse customer base (scientists, engineers, senior managers, others) and deploying scalable, fit-for-purpose HSE Programs and solutions.
- Demonstrated history of working with design, construction, and engineering firms and maintenance organizations.
- Experienced with commissioning, qualification, and validation in a cGMP environment.
- Demonstrated experience with cGMP requirements for the lifecycle of production equipment and the documentation requirements associated with a cGMP environment.
- Stock Options
- 401k Plan with Matching
- Medical, Vision and Dental Plans
- Long Term/Short Term Disability
- Life Insurance
- 3 Weeks’ Vacation
- 5 Personal Floating Days
- 8 Sick Days
- 6 Company Holidays
- Career Development and Training