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Safety, Health & Environment (SHE) Site Lead

Ort Rockville, Maryland, USA Anzeigen-ID R-194321 Veröffentlichungsdatum 23/04/2024

Join us as a Safety, Health, and Environmental (SHE) Site Leader at our start-up cell therapy manufacturing facility. This role is pivotal in developing, implementing, and maintaining comprehensive safety, health, and environmental programs. You will ensure compliance with all regulatory requirements and AstraZeneca corporate policies while handling risks associated with start-up activities, equipment qualification, permit acquisition, and facility growth.

What you will do:

  • Responsible for developing safety, health, and environmental policies in line with local, state, and federal regulations. 

  • Conduct risk assessments and hazard analyses, coordinate safety training programs, and serve as regulatory agencies' primary point of contact. 

  • Lead the investigation of accidents, incidents, and near-misses, and develop corrective and preventive actions to prevent recurrence.

  • Collaborate with cross-functional teams, conduct regular audits, handle emergency preparedness programs, and provide guidance on safety matters.

Minimum Qualifications:

  • Bachelor’s Degree in a related field 

  • Minimum of 7 years of SHE  experience

  • Experience in Human Tissues and Cell/Biologics/Laboratories

  • Ability to perform detailed risk assessments and prioritize assessed risks

  • Knowledge of regulatory requirements (i.e. OSHA, EPA, DOT)

  • Understanding of Good Manufacturing Practice (GMP) regulations and quality management systems

  • Ability to navigate ethical and regulatory complexities associated with working with human cells and tissues

  • Excellent communication and presentation skills

Preferred Qualifications:

  • Advanced degree or continuing education

  • Minimum of 10 yearsSHEexperience

  • Minimum of 5 years in the pharmaceuticals industry, preferably with GMP experience

  • Certification as a registered/certified biosafety professional (RBP/CBSP), certified safety specialist (CSP), registered environmental assessor

  • Previous SHE or operational experience in a BSL lab environment. 

At AstraZeneca's Operations department, we are breaking new ground and leaving a collective legacy. We are unrivaled leaders in this space, always doing it the right way with sustainable lifecycle management. With constant new products and launches, there's never been a better time to join us and shape our future with a big contribution to life-changing medicines. Our resilience helps us to thrive as we innovate and evolve. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you are driven, take smart risks, and can act quickly, then this is the place for you.

Ready to make a big impact? Apply now to join our team and contribute to life-changing medicines!



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