- Provide regulatory support and guidance to various cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into all researcher operations.
- Lead the regulatory efforts, including establishing and maintaining operations protocols, permit submissions, regulated substance and species tracking and monitoring, data preservation, and record keeping.
- Chair of Safety Committee, and Institutional Biosafety Committee (IBC) and Emergency Response Teams.
- Maintain close liaison with regulatory authorities, scientific, and CRO/CMO collaborators on matters that impact the regulatory responsibilities of the company.
- Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including BDPH, MADPH, DEA, USDA and FDA.
- Manage relationships with external regulatory counsel.
- Participate in the technical plan development process to assure projects are designed in compliance with regulations and applicable standards.
- Within the management and legal teams, propose, develop and implement regulatory policies and strategies.
- Design, develop, and deliver regulatory training to employees.
- Oversee, manage and support all EH&S employees, cross-functional teams and contractors
- Directly oversee EH&S Manager and/or contractors and assist in the implementation of EHS related protocols and trainings company wide
- Oversees Chemical Hygiene Officer and Biosafety Officer in compliance related tasks, including chemical inventory and organism database oversight.
- Oversee and manage on-site EH&S contractors including Triumvirate Environmental, Cintas, and Stericycle.
- Assist and support Shipping and Receiving team in IATA/DOT and regulatory compliance.
- Four-year degree (BS/BA) in Environmental Engineering, Biological Engineering, Chemical Engineering, Occupational Safety & Health, Environmental Science/Studies, or other applicable degree.
- 10+ years of Management and/or EH&S experience in a leadership role.
- Demonstrated ability to lead and promote safety programs that engage employees and enable a safe work culture.
- Strong track record of leading continuous improvement in functional areas.
- Strong understanding of and ability to manage systems under applicable regulatory controls – local, state and federal.
- Demonstrated influencing skills in a team environment workforce.
- Demonstrated experience in Root Cause investigation.
- Advanced interpersonal skills focused on collaboration, innovation, inclusion and communication.
- Experienced presenter and speaker; excellent writing skills.
Desired Capabilities and Experience
- Advanced degree (MA) in Management, Chemical Engineering, Biological Engineering, Chemical Engineering, Occupational Safety & Health, Environmental Science/Studies, or other applicable degree.
- Certified Safety Professional (CSP), Certified Industrial Hygienist (Comprehensive Practice preferred) and/or Certified Environmental Professional.
About Ginkgo Bioworks
Ginkgo Bioworks is the organism company. We design custom microbes for customers across multiple markets. We build our foundries to scale the process of organism engineering using software and hardware automation. Organism engineers at Ginkgo learn from nature to develop new organisms that replace technology with biology.