Environment, Health & Safety / Regulated Waste Management Specialist

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) / Regulated Waste Management 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 to Iovance’s production facility (IOVA-A) located within the American Red Cross Facility at 700 Spring Garden St, Philadelphia.

Responsible for day-to-day management of solid, hazardous, and regulated medical waste disposal program activities and supporting compliant EHS programs to all departments at both Philadelphia facilities.

Maintains compliance with Federal, State, and Local regulations governing waste management. Assists with handling all environmental aspects and impacts including air, water, waste, recycling, and reuse.

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. Assists with the day-to-day requirements and activities of the EHS incident management and reporting system.

Essential Functions and Responsibilities

• Maintain his / her assigned work areas in a safe and orderly condition.
• Responsible for the proper handling, documentation, inspection, and transportation of hazardous wastes.
• Identifies, documents, and recommends resolutions of hazardous or potentially hazardous conditions; follows through to ensure corrections have been made.
• Inspects and identifies all forms of waste to determine the proper method of disposal. Completes chemical waste profiles.

Ensures that waste determinations are made in a timely manner.

• Assist in the development and review of waste training and assist in presenting the annual emergency responder training.
• Must be able to respond and help mitigate emergency events regarding any waste, including hazardous materials.
• Operates balers, compactors, various pieces of material handling equipment, and other solid waste management equipment as required.
• 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.
• 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.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• High School Diploma or GED required.
• Bachelor’s degree in Occupational Safety, Industrial Hygiene, Chemical / Environmental Engineering, Process Safety Management, or a related technical discipline preferred.
• Minimum 3 years direct occupational safety or regulated waste management work experience required.

Preferred Education, Skills, and Knowledge

• RCRA Certification preferred.
• 40-hour HAZWOPER Certification preferred.
• Ability to use common hand tools safely and effectively with good mechanical aptitude.
• Working knowledge of US EPA, PA DEP, DOT / IATA, and / or OSHA regulations and other regulations and consensus standards strongly preferred.
• First Aid or EMT certification desirable.
• Working knowledge of six-sigma and operational excellence a plus.
• Experience with GMP environments and biotechnology processes preferred.
• 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 50+ pounds and maneuver containers weighing up to 500 lbs.
• Able to push and pull objects weighing up to 100 lbs.

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.

If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected].