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Orca Bio

Posted 6 months ago

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Specialist, Environment, Health & Safety

SacramentoOn-site

AI Summary

The Specialist, EHS develops, implements, and maintains environmental, occupational health, and workplace safety programs at Orca Bio’s Sacramento facilities, ensuring regulatory compliance and leading safety initiatives.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

Position Summary:
The Specialist, EHS is responsible for supporting the development, implementation, and maintenance of environmental, occupational health, and workplace safety programs and policies to ensure compliance with local, state, and federal regulations and multiple sites.
Location: Sacramento, CA (on-site). This role is primarily based at our "Sac02" commercial manufacturing facility on Metro Air Parkway (3–4 days per week), with regular time at our nearby "Sac01" site on Business Drive (1–2 days per week). Occasional travel to our Bay Area (Menlo Park) headquarters may be required (1–2 days per month).

Physical Demands

  • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

    • Work Conditions

  • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

    • Key Responsibilities

  • Ensure compliance with Cal/OSHA, EPA, DTSC, CDPH and other applicable regulatory standards
  • Conduct safety audits, inspections, and risk assessments to identify and mitigate safety, health, and environmental risks. Coordinate implementation of identified corrective actions or improvements.
  • Lead safety committees and represent EHS interests in cross-functional meetings and project teams.
  • Develop, coordinate, and deliver EHS training programs for employees (HazCom, LOTO, PPE, emergency response, etc.)
  • Investigate near-misses, incidents, and injuries, and recommend and track corrective actions. Manage associated documentation and reporting requirements.
  • Develop, maintain and update EHS policies, procedures, and documentation
  • Manage environmental programs including waste management, air emissions, and wastewater compliance
  • Manage the proper handling, storage, disposal, documentation, and regulatory compliance of biohazardous and hazardous wastes
  • Track and report safety metrics and environmental data
  • Support emergency preparedness and response planning
  • Collaborate with leadership to drive continuous improvement in safety performance
  • Maintain EHS documentation, including SDSs, permits, and reporting.
  • Lead or support emergency response plans, drills, and preparedness activities.

    • Qualifications

  • Bachelor’s degree in Environmental Science, Occupational Health & Safety, Industrial Hygiene, or related field preferred.
  • 5 years of EHS experience in a GMP environment, preferably in a cell therapy, biotechnology or pharmaceutical manufacturing facility.
  • Working knowledge of Cal/OSHA, EPA, DTSC, CDPH and other relevant regulations
  • Excellent leadership, communication, and interpersonal skills.
  • Excellent project and time management skills with the ability to manage multiple priorities in a fast-paced environment
  • Strong analytical, attention to detail, and problem-solving skills, and ability to make sound decisions
  • Certifications such as OSHA, HAZWOPER, CSP or CHMM are a plus.
  • This position requires on-site presence and typically involves regular office hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.
  • Gowning will be required for cleanroom access.

    • Skills

    CAL/OSHACDPHCHMMCSPDTSCEPAGMPHAZWOPERLOTOSDS

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