Executive Director, Preformulation

Employer
Merck
Location
Rahway, NJ, US
Posted
May 09 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: PRE000650

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 Preformulation Group is an integral part of the Pharmaceutical Science organization and has the key function of evaluating the physicochemical properties of small molecule and biological drug candidates to inform successful drug product development.

The Executive Director, Preformulation leads a diverse team of scientists and engineers who employ advanced characterization approaches to understand and predict molecule physical and chemical stability in the context of the formulation composition and process. The data collected from preformulation experiments, in total, form the basis of rational drug product development and provide the mechanistic understanding that fully supports the tactics and long range control strategies.

  • Prior hands on experience in material characterization techniques such as thermal analysis, spectroscopy, X-ray diffraction, laser diffraction/ light scattering and SEM are required.
  • The desire to apply new/novel characterization approaches to complex scientific problems is essential.
  • Experience in crystallization, salt and polymorph screening would also be valuable.
  • A strong knowledge of novel drug delivery systems including specialty drug/device combination products is desired.
  • Experience in the characterization of drug substances and formulations spanning multiple drug modalities would also be valuable.
  • Experience in utilizing design of experiments (DOE) methodology and statistics/data visualization approaches would be desirable.
  • A good understand of the correlation between product attributes and biopharmaceutics/pharmacokinetics is also desired.
    The preformulation leader champions the role of preformulation data in developing product, representing the data in various forums, and ensuring visibility of key data to influence product design.
  • Understanding GXP laboratory operation and documentation would be helpful as well as a desire to leverage predictive approaches to extrapolate long term drug product stability.
    Key leadership success criteria include building strong relationships with peers and cross-function partners within drug substance, discovery and manufacturing.
  • The individual would be expected to drive to the highest standards of scientific and operational effectiveness with the team.
  • Responsible for creating a learning environment, open to suggestions and experimentation for improvement as well as an environment where employees feel appreciated and are supported, enabling them to excel.
  • The leader will have the ability to drive practical research innovations that lead to strongly performing products, IP and external publication/presentation presence.
  • The leader links with the external scientific and regulatory community to understand and influence trends as well as to bring new technology and approaches back to Merck.
    The leader also creates and maintains a compliant and safe work environment.

Qualifications

Education:

  • PhD in chemistry, pharmaceutical science, chemical engineering or relevant scientific discipline.
Required:

  • Minimum of 7-10 years of experience in the pharmaceutical R&D, with relevant experience in Pharmaceutical Science.
Preferred:

  • Direct experience in advanced analytical characterization approaches, solid state chemistry, physiochemical characterization, discovery pharmaceutical science and/or biophysical characterization.
  • 3 years scientific supervision or people management experience
 

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.

  

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: Preclinical Dev Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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