Environmental Health & Safety Manager

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:

• Provide an environment for employees to reach their fullest potential.
• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.

Our values:

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

About the role:
The EH&S Manager will be responsible for developing, implementing, and managing AskBio's EHS programs in conjunction with corporate Global Operating Procedures and programs. This role will be responsible for monitoring site activities and ensuring compliance with federal, state and local regulatory requirements at the BioPoint site in Research Triangle Park, NC and the future peripheral NC expansions in 2023/24.
This individual will ensure EHS compliance across multiple functions, and will work closely with R&D, Finance/Procurement, Quality Assurance, Project Management, Facilities and Technical Operations to assess regulated activities.
S/he will develop, implement and oversee EHS programs, processes and systems to support Company’s efforts to achieve and maintain compliance.
Responsibilities:

• Support other US sites as needed
• Ensure routine reporting, compliance tasks, and deadlines are successfully completed within required timelines.
• Continuously monitor and review site operations and staff activities to ensure work process are conducted in a safe and compliant manner.
• May serve as point of contact for emergency events (i.e. chemical spills, injuries, or accidents).
• Help functional groups develop safe work procedures, investigate accidents/near misses, and implement programs and corrective actions to ensure Company culture continual moves toward best-in-class EHS programs and regulatory compliance.
• Continue professional development and coordinate with federal, state and local regulatory agencies to remain current and knowledgeable in the regulatory requirements that apply to Company and organization processes.
• Work with cross functional leaders and staff to identify emerging issues.
• Develop, implement, and maintain regulatory tracking processes, and records and document storage required to demonstrate compliance with regulatory permits and standards at federal, state, and local levels.
• Partner with Facilities and Human Resources team on workers’ compensation issues and escalations as necessary
• Represent EHS function/organization on specific internal or external projects.
• Provide guidance and expertise to site staff to develop and enhance understanding of the EHS regulatory requirements and industry best practices toward application and building of an enhanced EHS culture. Also includes:
• Asist with creation and implementation of EHS compliance audit calendar.
• Develop, implement, and maintain EHS compliance policies, procedures and plans in accordance with applicable federal, state, local requirements.
• Work collaboratively with business operations to implement safety and health initiatives including Job Safey Assessments, improved Standards of Practices, PPE requirements, etc. in according with company policies, EHS Management Systems and government regulations.
• Promote and facilitate the active exchange of best practices, procedures, lessons learned, and other pertinent EHS information across regional sites.
• Develop and present training classes to create awareness and understanding of compliance requirements with internal EHS process.
• Oversee the delivery of EHS training for employees, identifying appropriate and relevant content / providers and recommending required courses based on job positions and work-related hazards.
• Maintain and advise on the budget related to EHS spending and coordinate with departments and other business units as appropriate.
• Respond to agency informational requests and assist as point of contact and liaison during agency visits and audits.
• Develop procedures for performance measurement and evaluation; provide summary reports to business unit management.

Required Education & Experience:

• Knowledge and experience in waste identification and management, recycling, regulatory permitting, and reporting/data tracking.
• A minimum of 8 years’ experience in EHS compliance management; with at least 3- 5 years of experience within Lab Research and or pharma/biotech industry is preferred.
• Ability to engage, communicate, present, and facilitate across all levels of the organization.
• Ability to effectively challenge and influence others in an objective and constructive manner.
• Experience working with and reporting to regulatory agencies.
• BS degree in a biology, chemistry or environmental science or related field.

Preferred Skills & Experience

• GXP environment.
• Developing and implementing Biosafety and/or Chemical Hygiene Plans and use of risk assessment tools (JSA, JHA).
• Preferred work experience in:
• Developing and implementing a multimedia EHS program in a healthcare, laboratory, or pharmaceutical/biotechnology setting.
• Professional certifications in one of the following: CIH (Certified Industrial Hygienist), CHMM (Certified Hazardous Materials Manager), or CSP (Certified Safety Professional).
• Developing and conducting staff training related to: Chemical Hygiene, Hazard Communications, Biosafety, Bloodborne Pathogens, PPE, General Safety, Hazardous Waste Management, and others.
• Drafting work instructions, procedures and compliance plans and programs..

Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected].
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.