Director, Environmental, Health Safety

Company: BioCentriq
Location: Newark
Posted on: March 18, 2023

Job Description:

Director, EHS (Environmental, Health Safety), BioCentriq
BioCentriq is a Contract Development and Manufacturing Organization (CDMO) specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations, and quality professionals, work with our clients to translate groundbreaking treatments and manufacture supplies for clinical trials.The novel therapeutics we focus on require constant innovation and creative thinking for the clinical translation and subsequent GMP manufacturing to be successful. BioCentriq has infrastructure and subject matter expertise that meet the challenges faced by our industry. Our state-of-the-art facilities include Process Development labs and GMP manufacturing suites to support the development and clinical manufacturing needs of our clients.The Manager, EHS will be a key member of the Quality team at BioCentriq and support the development, clinical manufacturing, and laboratory teams by implementing, managing, and continuously improving the EHS programs for our sites and corporate offices.
The ideal person has key experiences in EHS for biologics and can demonstrate a solid understanding of the requirements of the roles.
As BioCentriq's Director, EHS you will: - Develop, implement, and review EHS standards and supporting documents in compliance with federal, state and local requirements such as Emergency Preparedness and Response, Respiratory Protection, Lockout, Hot Work Permitting, Lab Safety Blood Borne Pathogens, Haz Waste Management, including necessary training programs. - Create Job Hazard Analysis program to evaluate risks associated with cell therapy and supporting laboratory, operations, and warehouse activities for risks to personnel and the environment including engineering and administrative controls, PPE and safe work practices. - Investigate all accidents and incidents, and determine the root cause, offering alternatives for correction of the condition(s) that resulted in the Incident Maintain mandatory OSHA Logs and investigation reports (three-year history, minimum). - Perform trend analysis on an ongoing basis to determine current risk mitigation priorities and adjust control measures activities accordingly. - Advise on the risk assessment of new equipment, processes or facilities, consistent with regulatory requirements. - Maintain mandatory records (logs, accident reports, injury reports, IH sampling, chemical inventory, SDSs, medical clearances. spill reports, etc.) compliant with regulatory requirements. - Execute permit applications and maintain compliance. - Establish key metrics to drive EHS culture and performance. - Collaborate with leaders, facilities, and other committees on designing and implementing all aspects of Emergency Response and Preparedness. - Coordinate with landlords the performance of periodic (semi-annual) emergency. response/evacuation exercises and maintain the appropriate documentation of those exercises. - Assure cross functional Biological Safety Programs are evaluated with the potential hazards and implemented at each of the sites. - Establish procedures/processes to assure guidance to site personnel managing contractors on-site work. - Perform and document periodic (minimally on an annual basis) comprehensive safety and health audit of each facility and track closure of findings by partnering with site/functional management. - Provide quarterly reports to EHS Steering Committee on the status and direction of EHS metrics which assesses program status, program priorities, accomplishments and resource and budgetary needs. - Primary contact with regulatory agencies with regard to EHS issues.

Required Qualifications: - Bachelors' degree in Engineering (e.g Chemical, Electrical, mechanical) or Sciences (e.g. Cell Therapy, Biology, Physics) - At least10 years of direct EHS experience in manufacturing preferably biologics pharmaceutical space - Working knowledge and application in manufacturing environment of high-risk work operations, preferably biologics - Requires expertise in Biosafety Level 1 and 2 (BSL-1 and BSL-2) containment and practices. - Excellent written and verbal communication skills, ability to communicate with all levels of the organization. - Self-motivated, flexible, creative, able to prioritize, and work in a fast-paced, dynamic environment and effectively deal with conflicting and changing priorities. - Strong influencing and collaborations skills - Ability to gown in cleanroom garments and personal protective equipment (gowning coverall, masks, gloves, goggles, respirator (as required). - Hands on development and execution of training curriculum, content and delivery - Experience developing strategy, roadmaps, policies and SOP's

Keywords: BioCentriq, Newark , Director, Environmental, Health Safety, Executive , Newark, New Jersey