Environment, Health & Safety (EHS) Specialist (Friday -...

Overview Iovance is an immune-oncology company with a mission is to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. The Company recently announced FDA Accelerated Approval for the first and only T- cell therapy now approved for previously treated unresectable or metastatic melanoma. AMTAGVI (lifileucel) is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically, or has spread to other parts of the body, called unresectable or metastatic melanoma. The Company also has a robust pipeline that includes studies in various phases for cervical cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma. Iovance Biotherapeutics is seeking an Environment, Health, & Safety (EHS) Specialist to join the team based at the Iovance Cell Therapy Center (iCTC) located in the Philadelphia Navy Yard, reporting to the Senior Director of EHS. This position will also provide support, as needed, to the American Red Cross Facility at 700 Spring Garden St, Philadelphia. SHIFT: Friday - Monday Responsible for supporting compliant EHS programs to all departments at the iCTC facility. Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives. Partners with operations to develop objectives to achieve these goals in alignment with site business goals and values. Provides technical leadership to ensures the biological safety programs adhere to federal, state, and local EHS regulations. Manages the day-to-day requirements and activities of the EHS incident management and reporting system. Essential Functions and Responsibilities Provides support to the site to ensure compliance with federal, state, and local environment and safety, laws, regulations, codes, and consensus standards as well as internal policies and procedures. Provides input to policies and procedures and assists with the development delivery of associated training presentations. Completes job hazard analysis (JHAs) and safety inspections; assists with IH monitoring, incident investigations and environmental reporting and permit compliance. Responsible for hazardous and biohazardous waste management including the proper handling, documentation, inspection, and transportation of regulated wastes. Participates in and supports EHS operational and tier discussions, safety committees and teams, self-assessments, and audits. Reviews processes, facilities, procedures, and management of change documents to assure conformance to recognized EHS regulations, standards, and guidelines. Provides support to staff in completing injury/illness investigations, additional training, data analysis, and addresses specific concerns as they are raised. Participates in regulatory inspections and assists in addressing noted concerns and citations. Reviews site data for the EHS reporting system (Enablon); identifies data gaps and other concerns; generates output reports and dashboards using the appropriate BI tools. Perform miscellaneous duties as assigned. Travel May require travel based on business needs. Required Education, Skills, and Knowledge Bachelor's degree in Occupational Safety, Industrial Hygiene, Chemical Engineering, Process Safety Management, or a related technical discipline required. Minimum 3-5 years direct occupational safety work experience required. Technical working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, and other regulations and consensus standards required. Preferred Education, Skills, and Knowledge CIH, and/or CSP certification desirable. First Aid, EMT or Paramedic certification desirable. Working knowledge of six-sigma and operational excellence a plus. Experience with GMP environments and biotechnology processes preferred. Demonstrated ability to quickly interpret complex regulatory issues and provide recommended course of action. Strong written and verbal communication skills with the ability to communicate clearly to 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 working knowledge of computers and programs including Microsoft Office, SharePoint, Teams, Enablon, etc. Excellent interpersonal, relationship management, and organizational skills. Physical Demands and Activities Required: Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc. Must meet requirements for and be able to wear a half-face respirator. Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps. Able to crouch, bend, twist, reach, and perform activities with repetitive motions. Must be able to lift and carry objects weighing 45 pounds. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline Work Environment: This position will work in both an office and a manufacturing lab setting. When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors. The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. 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Created: 2024-10-22