Environmental Health Safety Management

Robert M. Rovinsky, MES, CHMM

**** ***** **

Philadelphia, PA 19119

***********@*****.***

SUMMARY

I am a team oriented leader and performance driven professional with over twenty-five years of broad-based experience in risk management. My work ensures that the health and safety of employees, the public, and the environment are maintained to the strictest of standards by achieving operational excellence through utilizing a rigorous, proactive, value-added approach with strategic vision and innovation while recognizing the bottom-line.

Professional undertakings include: • Laboratory, facility and manufacturing regulatory compliance comprising OSHA, EPA, FDA, EMA, NIH, NRC, DEA, Multi-State, Local, International requirements • Contract Management • Project Management • Public and government/regulatory agency relations • EHS/Quality Management Systems • GMP • Budgeting Major Programs • Detailed design, construction and commissioning/qualification of chemical, biological and radiation research laboratories and pharmaceutical and biotechnology manufacturing facilities • Property Acquisition-Due Diligence • Team Development • Supervising Professional Staffs • Advising Senior Management • Successful interaction with persons of diverse cultural, educational and demographic backgrounds both domestically and internationally.

EXPERIENCE

Director Regulatory Compliance and Risk Management June 2016 – April 2017

Frontida BioPharm Inc, Philadelphia, Pennsylvania

• Responsible for oversight of all controlled substances management, Environmental Health and Safety, loss control and related cGMP quality risk management systems.

Associate Director Environmental Health & Safety – Americas January 2015 to May 2016

SUN Pharma, Cranbury, NJ

• Responsible for oversight of all Environmental Health & Safety and related Sustainability activities at Sun Manufacturing Systems Operations throughout the Americas while also providing subject matter expertise globally.

• Developed and successfully implemented enterprise-wide behavior-based EHS management programs.

• Instrumental in developing and implementing standardized risk management programs for occupational safety and cGMP compliant cross-contamination and cleaning validation requirements for global operations.

• Provided essential guidance and management for the design and operation of high-hazard compound facilities that led to the successful launch of products critical to the company’s success.

• Key contributor of a global communications initiative that promoted company expectations concerning Quality and EHS that transcended language and cultural barriers.

Robert M. Rovinsky

Corporate Environmental Health & Safety Manager

September 2009 to December 2014

URL Pharma, Philadelphia, Pennsylvania

• Established robust Company Environmental Health & Safety Department.

• Responsible for the overall environmental health and safety requirements for multi-site pharmaceutical company that includes laboratory research, pilot plant/scale-up operations, production, packaging and distribution of products.

• Developed and applied effective risk-based manufacturing strategies aligned with Risk-MaPP to assess potential hazards of Active Pharmaceutical Ingredients (including Highly Hazardous/Potent Compounds), Intermediates and Novel compounds that declares suitable consistent controls are defined and applied by integrating engineering/industrial hygiene approaches to ensure the safe handling of materials in compliance with EHS occupational exposure and cGMP cross-contamination standards.

• Reduced accident/incident rate to levels below relative industry average.

• Implemented waste management practices that reduced costs by $250,000 over a two-year period.

• Spearheaded effort to safely conduct research and development of potent compounds in-house - saving over $1,000,000.

• Created and implemented the use of a computerized EHS Corrective Action Management System that incorporates prioritizing risks, root cause analysis and the foundations of continuous improvement.

• Created functional multi-department EHS Committee.

• Oversee all Security Operations.

• Crafted and implemented Crisis Management Plan based on “Incident Command System”.

• Managed Worker’s Compensation Program

• Managed all Security and loss control programs and systems. Environmental Health & Safety Manager

July 2003 to September 2009

Wistar Institute of Biomedical Research, Philadelphia, Pennsylvania

• Directed comprehensive environmental health and safety efforts.

• Responsible for EHS oversight of more than 30 research programs, ancillary departments and facilities including a Biosafety Level 3 containment laboratory; a 27-room accredited animal research facility and 137Cs irradiator.

• Developed and implemented programs in coordination with the Department of Homeland Security to secure chemical, radiological and biological materials.

• Developed aseptic techniques for research and processing of materials.

• Developed and implemented a waste minimization/recycling program that produced a sixty-percent recycling rate while reducing waste disposal costs by twenty percent in one year.

Robert M. Rovinsky

Emergency Preparedness Planner

August 2002 to July 2003

Exelon Nuclear, Kennett Square, Pennsylvania

• Implemented all offsite planning and training IAW NRC & FEMA standards.

• Collaborated with State of Pennsylvania, Maryland, County Officials, Municipal Agencies, NRC, and FEMA officials involving radiological emergency response team strategies and vision.

• Trained offsite emergency agency personnel in proper protocols for radiological protection, surveillance and decontamination.

• Prepared and submitted public information press releases for broadcasting. Industrial Hygienist

October 1999 to August 2002

University of Pennsylvania, Philadelphia, Pennsylvania

• Implemented the University’s Environmental, Radiation and Occupational Health Programs (Included over 1500 research labs and Facilities Operations).

• Trained University personnel in chemical, radiological and biohazardous materials/waste handling and disposal.

• Managed Air Compliance.

• Performed due-diligence as member of cross-functional asset acquisition team.

• Developed and implemented biosafety protocols.

• Evaluated and recommended laboratory/facility design.

• Conducted laboratory audits and job hazard analysis ensuring OSHA’s Chemical Hygiene Standard and the University’s Biosafety Protocols were applied successfully.

• Developed safety programs including confined-space entry & lockout/ tagout. Environmental Health Technician

June 1992 to September 1999

United States Air Force Reserves, Willow Grove, Pennsylvania (Civil Service)

• Developed and implemented a pollution prevention program that reduced the use of extremely hazardous substances by more than forty percent.

• Managed environmental programs relating to RCRA, TSCA, SDWA, CWA, CERCLA, SARA III, NEPA and CAA including RMP.

• Managed Process Safety Management program.

• Emergency/Disaster Response Coordinator

• Radiation Safety Officer

• Chemical Hygiene Officer

• Respiratory Protection Program Manager

• Hazard Communications Program Manager

• Designed and maintained drinking and waste water systems.

• Evaluated, designed and implemented strategies/technologies to remediate contaminated properties.

• Member of cross-functional team responsible for multi-site audits that included the tenents of ISO 14001 and OHSAS 18001.

• Total Quality Management Systems – Continuous Improvement Instructor Robert M. Rovinsky

Bioenvironmental Engineering Specialist

November 1989 to February 1993

United States Air Force Reserves, Willow Grove, Pennsylvania (Military Status)

• Noncommissioned Officer in charge of Bioenvironmental Engineering Services.

• Implemented effective counter measures to nuclear, chemical and biological weapons.

• Instructed nuclear, chemical and biological detection & defense classes.

• Managed programs to ensure respective EPA, OSHA, State and Local compliance.

• Promoted and administered military public health requirements.

• AFSC: 4B091

EDUCATION

University of Pennsylvania, Philadelphia, Pennsylvania May 2002 Master of Environmental Studies (Policy/Risk Management)

• Included studies at the Wharton School of Business Temple University, Philadelphia, Pennsylvania May 1998 B.S. Environmental Engineering Technology

U.S. Air Force School of Aerospace Medicine, Brooks AFB, Texas Bioenvironmental Engineering with Associated Specialties SafeBridge Consultants

Pharmaceutical Potent Compound Safety and Advanced Concepts CERTIFICATION

CHMM

PROFESSIONAL ASSOCIATIONS

Member International Society for Pharmaceutical Engineering Active Participant in the Occupational Toxicology Roundtable Member Air & Waste Management Association

Member National Fire Protection Association

Member American Biological Safety Association

Member National Safety Council

Member American Industrial Hygiene Association

Third Party Technical Expert serving on Institutional Biosafety Committee of University of the Sciences – Philadelphia

SOFTWARE PROFICIENCIES

MS Office, Sharepoint, Project, Visio, Adobe Acrobat, Photoshop, Illustrator TEACHING AFFILIATIONS

Guest Lecturer – University of Pennsylvania, Institute of Environmental Studies

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