Safety, Health & Environment (SHE) Site Lead
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 years’ SHEexperience
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!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.