Position Summary:
ultracurious – Apply your biggest ideas in courageous ways
Ultragenyx is seeking an EHS Manager to lead the development, implementation, and continual improvement of critical EHS regulatory compliance programs for our Gene Therapy Manufacturing Facility (GTMF) and Quality Control Laboratories. This role will provide guidance and support on these program areas and ensure effective integration into site operations and adherence to Global EHS standards. This position has a key role in driving a culture of excellence in EHS and guiding the GTMF towards becoming a leader in the life sciences industry.
This role will travel between Bedford, MA and Woburn, MA.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- Develop and implement EHS programs and training to ensure compliance with federal, state, and local regulatory requirements as well as conformance to industry and Ultragenyx Global EHS requirements and standards.
- Assist with high hazard program management, DIG prevention, permit-to-work and JHAs.
- Lead detailed incident investigation, root cause analysis, creating actionable CAPAs, inspection readiness, and risk assessments.
- Active partner with stakeholders to risk assess and implement controls.
- Oversee chemical and biological waste management programs, serving as a Hazardous Waste Coordinator and participating in spill response programs.
- Promote EHS awareness in a manner that encourages cooperation and improves enthusiasm and morale.
- Collaborate with Ultragenyx Sustainability for annual ESG opportunities.
- Additional projects and duties may be assigned within the scope of EHS.
Requirements:
- Bachelor's degree in the EHS field; Master's degree preferred.
- 5 plus years of experience in the biotechnology or pharmaceutical industry, with 1-2 years in EHS leadership/management.
- Comfortable working in a fast-paced environment and capable of pivoting priorities to support business needs.
- Deep understanding of high-risk EHS programs including Lock-out Tag-Out, flammables material requirements, fall from heights, confined space entry, hot work, permit-to-work systems.
- Professional certification (e.g., CBSP, CIH, CSP, ASP) is highly preferred.
- Experience with GMP manufacturing operations strongly preferred.
- Knowledge of industry and federal, state and local regulatory requirements.
Physical Demands/Work Environment/Safety Considerations:
- Stand for extended periods of time with periodic stooping / bending / kneeling
- Able to lift, push, pull up to 50lbs.
- Climb ladders and stairs of various heights.
- Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
- Certain tasks may require the use of a respirator; medical clearance will be required in advance.
- Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
- Working in temperature-controlled environments (cold rooms). #LI-CS1 #LI-Onsite
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
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