With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

This position provides EHS & Security support for San Diego area Abzena operations to ensure regulatory compliance, workplace safety and security, environmental impact control, and site safety culture development.

Responsibilities

• Policy development: Creating and implementing policies, procedures, and programs to ensure workplace and environmental safety.
• Compliance: Ensuring the organization complies with local, state, and federal regulations.
• Training: Developing and coordinating training programs to ensure employees develop safe work practices.
• Site Security: Assisting in development and implementation of security post orders and procedures. Provide support for security monitoring systems, provide supplemental on-site and remote security guard duties where necessary.
• Audit Support: Conducting safety audits and hosting planned and unplanned regulatory and other 3rd part audits.
• Communication: Communicating with regulated departments and stakeholders to ensure comprehension and adherence to regulatory and procedural requirements.
• Risk Management: Identifying and reducing risks to health and the environment.
• Waste management: Manage regulated waste disposal procedures, processes and implementing systems to minimize waste and reduce costs.
• Permit Management: Preparing applications for permits to install, operate, or modify pollution control systems.
• Incident investigations: Participating in accident and incident investigations to identify root causes and implement corrective action plans and effectiveness checks.
• Emergency Management: Work with EHS Director and Security to manage emergency events, develop emergency action plans and plan/execute drills.
• Maintenance and Construction: Ensure on-site facilities and 3rd party contractors plan and safely execute planned and unplanned maintenance, calibration, and construction projects.
• Reputation management: Protecting the company's reputation through regulatory compliance, ethical practices, on-time reporting and transparency.
• Develop and deliver the necessary EHS employee and contractor training.
• Develop and maintain required EHS written policies, procedures and work instructions.
• Maintain accurate EHS records to report to onsite management teams.
• Conduct risk assessments related to jobs performed by employees and implement risk mitigation strategies.
• Coordinate and help manage site ergonomics program.
• Conduct appropriate internal inspections and audits and ensure corrective actions are implemented and documented.
• Coordinate external regulatory audits and inspections and ensure timely implementation and documentation of corrective or preventive actions.
• Ensure compliance of hazardous waste management and hazardous materials transportation programs.
• Assisting with completing, documenting, and submitting all required EHS reports and recordkeeping information.
• Respond to and investigate events including accidents & injuries, chemical & biological material incidents, and near-miss events. Determine root cause and drive closure of effective corrective / preventive actions as assigned.
• Help coordinate the site’s EH&S related committees (Safety Committee, First Responders, Spill Response etc.)
• Manage safety incidents and observation electronic reporting systems (using Smartsheet)
• Prepare and manage environmental compliance reports and permits.
• Travels as needed between San Diego sites to perform necessary job functions.
• Required to perform unspecified tasks as needed to ensure team members’ health & safety, protect the local environment and ensure business success and continuity.
  
  

Qualifications

• 5 or more years relevant experience.
• 4-year degree in science field (or other with field-specific training/certifications/experience).
• Ability to recommend procedure modifications or improvements.
• Knowledge of applicable Federal Regulations (29, 40, 49 CFR), California OSHA, DEHQ, and other local laws and ordinances.
• Proven ability to use MS Office applications, property/access control security systems, learning management systems, and enterprise software solutions such as IFS, Smartsheet, Power BI are highly desirable.
• Ability to operate effectively within FDA-regulated environments, providing reliable support during compliance and client audits, interactions, and requests.
  
  

$100,000 - $130,000 a year

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.