Executive Director, Biologics Upstream Process Development

Kenilworth, NJ, US
February 20 2018
Organization Type
Requisition ID: BIO005082

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.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

The Biologics Process Development & Clinical Manufacturing organization within Merck Research Laboratories is responsible for developing the drug substance manufacturing processes for Merck’s biologics pipeline, including cell line, upstream and downstream process development.  We work closely with colleagues in Discovery, Preclinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and we efficiently produce drug substance to supply clinical trials.  We are also responsible for late stage/commercial process development and development of new manufacturing technologies.  We work with our partners in the Merck Manufacturing Division to commercialize and launch new products.  

This is a leadership position for upstream drug substance process development, which will operate under the general scientific and administrative direction of the Associate Vice President, working with internal and external partners. The individual will demonstrate a deep scientific understanding of the product and process sciences, and will have broad, experience-based skillsets in process and technology development.  Key responsibilities include:

  • Leads the Upstream Process Development organization, providing scientific and strategic leadership for development of manufacturing processes to support Phase I/II/III clinical and commercial manufacturing.
  • Partners with colleagues in Discovery, Downstream Process Development, Analytical Sciences and Manufacturing to develop integrated manufacturing solutions that achieve quality by design targets with robust control strategies.
  • Networks with academic, industry and regulatory agency thought leaders and leads development and implementation of upstream process technologies.
  • Develops scientific capabilities, infrastructure and systems to efficiently support Merck’s fast growing biologics pipeline.
  • Develops staff to maximize utilization of talent and work effectively in cross-functional team settings.



  • A Ph.D in Chemical Engineering or Biological Sciences with a minimum of 12 years of experience, OR a Masters Degree in Chemical Engineering or Biological Sciences with a minimum of 15  years of experience.

  • Proven record of accomplishment in upstream process and technology development for production of recombinant proteins.  
  • Experience in cell culture and working knowledge of downstream & analytics.   
  • Strong technical, business & financial skills, ability to manage multiple programs in a matrix environment, strong collaborative skills; ability to work strategically as well as in a detail-oriented framework.  
  • Demonstrated ability to manage people.  
  • Excellent oral and verbal communication skills.

  • Successful track record of introducing new technologies into GMP manufacturing. 
  • Experience with late stage commercial process development and process characterization.
  • Experience leading cross-functional, highly complex project teams.  
  • Proven ability to translate organizational objectives into actionable strategies.  
  • Recognized as an expert in the field with experience managing external collaborations.   

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.


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Job: Bio Process-Ferment/Cell Cultr
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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