Associate Director, Global Safety and Environment, Corporate Biosafety Officer

Kenilworth, NJ, US
October 26 2017
Organization Type
Requisition ID: ENV000516

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. This position will be responsible for the oversight of the company Biosafety program throughout the North America and other regions (e.g. AP or Latin America) as required and will: 
  • Provide support and expert advice to Merck sites upon their request. 
  • Provide training/ mentoring, technical expertise and hands-on site support to new and developing biosafety officers. 
  • Audit facilities and conduct biosafety program reviews as required. 
  • Support biorisk assessments and site/ regional biosafety committees/ IBCs for biological agent and material use across sites. 
  • Develop policies and procedures to facilitate the safe handling of biological agents and materials from Risk Group 1 through Risk Group 4 at both small and large scale; evaluate and support verification testing of risk mitigating controls. 
  • Support biorisk assessments for biological agent and material use across sites. 
  • Develop and deliver general biosafety/biosecurity and pathogen specific training for sites; support site Biosafety Officers with implementation as needed. 
  • Drive regulatory and Merck Biorisk Management Standard implementation and compliance across sites. 
  • Partner with Merck Biosafety Officers to coordinate biosafety program activities, drive program performance, consistency and efficiency, and develop the biosafety knowledgebase across sites. 
  • Identify, interpret and perform impact analysis on emerging global biosafety regulations, guidelines and consensus standards. 
  • Identify, evaluate/ validate and provide technical information and advice across sites on new and emerging technologies impacting biological safety. 
  • Support Third Party Assessment Teams with management of 3rd party providers (e.g. laboratories, consultants, contract manufacturing organizations) by providing biosafety technical expertise; support due diligence activities for biological facilities and operations. 
  • Support biological facility decommissioning activities as required. 
  • Provide input to biohazard emergency response plans and pandemic planning & preparedness. 
  • Assist US Select Agent and Toxin sites with Biosafety Plan, Security Plan and Incident Response Plan development and training. 
  • Evaluate, trend and communicate biological incidents across Merck sites and develop accident prevention programs to mitigate risk. 
  • Provide technical assistance and guidance on basic and complex biological control solutions. 
  • Support Global Employee Health Medical Surveillance program development. 
  • Support Global Trade Compliance (GTC) and MRL/MMD/MAH as SME with biological agent and material US import/export permitting. 
  • Support Global Trade Compliance as SME with Deemed Export program development and implementation. 
  • Create Vaccine Agent Summary Sheets (VASS) for Merck human health and animal health products. 
NOTE:  Travel for this position is expected to be 30% and will include international travel for time periods up to two weeks.


Education Minimum Requirement:
  • Bachelor's degree in biological sciences or related field with molecular biology, virology and/ or microbiology. A Master's degree is preferred.
Required Experience and Skills: 


  • Detailed working knowledge of biosafety, biosecurity, and containment facility/ device regulations, guidelines and consensus standards in US. Familiarity with non-US regulations. 
  • Experience representing EHS interests on Engineering Project Teams for biological laboratory, vivarium, pilot plant, or production area construction and/or renovation. 
  • Proficiency in development of technical requirements, communications and training programs for Biosafety and Biosecurity, and for dissemination to a global organization at the senior and line management levels as well as operational level colleagues. 
  • Certified Biological Safety Professional (CBSP) and/or Registration as a Registered Biosafety Professional (RBP). 
  • Ability to travel internationally for time periods up to two weeks. 
  • Ability to work independently and meet timelines in a fast-paced team-based environment. 
  • Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude. 
  • Ability to foster collaboration and consensus building among colleagues in an international workplace.
Preferred Experience and Skills: 

  • Ten years of progressive EHS experience in pharmaceutical, biopharmaceutical, biotechnology or related industry with direct responsibility for EHS program development and management. 
  • Ten year’s experience managing a comprehensive biosafety program at the site, regional and/or global level. This includes small and large-scale biosafety and small and large animal biosafety. Working knowledge of emergency response program management as it relates to biological agent or material release. 
  • Experience working with Global Occupational Health to support the establishment of Medical Surveillance programs. 
  • Working knowledge of Biosafety regulations, directives and guidelines (North America legislation, BMBL, NIH, CDC, USDA, OSHA, ARS, ANSI, ISO, WHO, NSF, IATA/DG), non-US regulations and guidelines and global/industry consensus standards (CWA 15793:2008). 
  • Experience in large and small scale biosafety. 
  • Experience with large and small animal biosafety.  
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 


If you need an accommodation for the application process please email us at

   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement

Job: Env, Health & Safety Generic
Other Locations:
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

Similar jobs

More searches like this

Similar jobs