Senior Director, Global Environmental Health & Safety ( EHS ) Occupational Toxicology

Mylan   •  

Morgantown, WV

Industry: Medical Devices & Diagnostics

  •  

Less than 5 years

Posted 360 days ago

For Us, It's A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

 

Make A Difference

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:

  • Provide pharmacology, toxicology and risk assessment expertise to support Global EHS initiatives concerning research and development, manufacturing, and packaging of Mylan products.
  • Respond to global requests for health hazard assessments and provide necessary expertise to support these functions. Investigate, research, and compile reports and product assessments that are necessary and required for Mylan products to meet all health hazard evaluation compliance commitments.
  • Perform risk assessments for a diverse portfolio of pharmaceuticals including small molecules, NCEs, biologics, nutraceuticals, lab chemicals, OTC in varied settings like APIs, OSD, Injectables, complex products, CMO, R&D and respiratory facilities. Support product stewardship initiatives. Author SDSs compliant with GHS, OSHA, CLP, WHS, WHMIS, RCNZ- HSNO, IATA, IMDG, DOT, ADR, and other global transportation regulations.
  • Provide toxicology based Environmental Risk assessments and support AMR and PiE initiatives. Use principles of risk assessment to develop scientifically defensible Occupational Exposure Limits, Predicted Environmental Concentrations and Predicted No Effect concentrations. Provide assistance with the Industrial Hygiene program and its associated studies, data and reports at Mylan facilities.
  • Participate in the following supervisory functions within the department as required: Interviewing, hiring, training employees, setting expectations, organizational development, performance management, succession planning, motivating, coaching, and problem resolution.
  • Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives.

 

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

  • Ph.D. degree or equivalent in Pharmacy, Pharmaceutical Sciences, Toxicology or a related field, and 2 years of experience in the position offered or a related position, including 2 years of experience with: Understanding and interpreting FDA regulations and guidance documents; Understanding and interpreting GMP, ICH, EMA, MHRA chapter 3 and 5, ISPE Schedule M requirements in support of quality and manufacturing operations; Assessing the persistence, bioaccumulation and ecotoxicity of products to support environmental risk assessments for product markets; Interpreting toxicological and pharmacological data to calculate and support various occupational exposure and environmental limits; Reviewing documentation and data for product registration for OTC market requirements; and Reviewing technical documentation including product labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications

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