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Director, CMC Biologics

Merck & Co., Inc.

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Location: Kenilworth, NJ Posted Date: 4/17/2013 Position Type: Full time Job Code: REG001200 Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Director, CMC Biologics
Kenilworth, NJ
REG001200

Responsibilities include but are not limited to:
. Leads team within CMC Biologics responsible for the preparation of new filing applications and maintenance of chemical and pharmaceutical manufacturing and control (CMC) documentation for worldwide registration.
. Requires continual correspondence and interaction with regulatory agencies and other Merck scientists to support either new or in-line product filings worldwide.
. Maintain working knowledge of current governmental and worldwide requirements for initial registration, re-registration and post-approval changes.
. Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems.
. Ensures consistency in practices, champions best practices and promotes operational excellence.
. Leads others in the biopharmaceutical industry and drives regulators to reduce the regulatory burden of bringing new medicines to market and making post approval improvements in CMC Biologics.
. Supports talent development within team and within department.

Requirements

Requirements:
. BS/BA Degree in biologic sciences, biochemical engineering, or a related discipline. Advanced degree preferred.
. A minimum of 7 years Industrial/regulatory experience in biologics research, development and/or manufacturing
. Prior experience with the filing and/or approval of Biologics License Application (BLA)

Preferred Experience and Skills:
. Minimum 10 years biologics experience

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.

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