Senior Manager Environment Health Safety

Overview

Iovance is an immune-oncology company with a mission to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. The Company received 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) Senior Manager 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 at Iovance’s Production Facility (IOVA-A) located within American Red Cross Facility at 700 Spring Garden St, Philadelphia and may be a “remote” resource for our Research and Process Development Labs in Tampa, depending on experience and qualifications.

Responsible for providing 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 ensure 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

• Serves as the site subject matter expert regarding general safety, chemical hygiene, biosafety (BSL 2), and environmental management.
• Implements new and updates existing EHS programs to ensure compliance with federal, state, and local environmental, safety, medical surveillance and sustainability laws, regulations, codes, rules, and consensus standards.
• Provides and executes programs, policies, procedures, and trainings as the site SME for high-risk work programs including but not limited to working from heights, electrical safety, hot work, confined space entry, lockout tagout, and contractor safety.
• Completes hazard assessments, process hazard analysis, life safety reviews, incident investigations, environmental reports, permit applications (as needed) and coordinates Industrial Hygiene monitoring.
• Leads site safety committees and teams, participates in and supports EHS operational and tier discussions, 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); manages user permissions; identifies data gaps and other concerns; generates output reports and dashboards using the appropriate BI tools; tracks and communicates EHS score card metrics.
• Perform miscellaneous duties as assigned.

Travel

• May require up to 5% domestic travel.

Required Education, Skills, and Knowledge

• Minimum of 9 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 4 years experience; or equivalent experience.
• Bachelor’s degree in Occupational Safety, Industrial Hygiene, Chemical Engineering, Process Safety Management, or a related technical discipline required.
• Technical working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, and other regulations and consensus standards required.
• Flexible Worker – primarily day shift. However, must be prepared to flex schedule to support off shifts as needed due to the site being 24/7 facility. Must be a flexible and agile worker to meet wider leadership duties.
• Typically requires a minimum of 9 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 4 years experience; or equivalent experience. Some barriers to entry exist at this level, requiring department review.

Preferred Education, Skills, and Knowledge

• RBP, CBSP, CIH, and/or CSP certification preferred.
• EMT certification is 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 courses 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 accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request 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 deadlines.

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.

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