Senior Specialist, Global Technical Operations External Biologics Job

West Point, PA, US
February 17 2017
Senior Specialist, Global Technical Operations External Biologics-CHE005184


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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Global Technical Operations External Biologics Senior Specialist will be responsible for the management of the technical interface between Merck and our External Partners (EP) supporting Bulk Biologics Drug substance manufacture. This individual will lead and execute technical transfers to and from External Partners. Representative will provide manufacturing process support to External Partners to resolve production issues and to provide guidance on process and capacity optimization. The incumbent must have broad bulk biologics drug substance manufacturing experience, strong leadership skills, business acumen and interpersonal skills.

Activities will include:

- Reports to Director, Global Technical Operations External Biologics, and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues.

- Executes technology transfers, leads site readiness activities by identification of site readiness risks and develops mitigation plans.

- Provides on-going technical support to External Partners to resolve manufacturing issues, investigations and develops plans to meet capacity needs.

- In concert with Commercialization, Quality, and Regulatory, ensures that EP's are inspection ready for all new product introductions and transfers.

- Develops and executes validation strategies for new and existing products.

- Provides a 'calibrated' technical review of External Partners process change requests, deviations, and Master Batch Record changes.

- Understands the true regulatory requirements and partners with Operations, Quality, and the External Partners to develop more efficient ways to meet these requirements.

- Collaborates with External Partners to achieve business goals and establishes a common culture that benefits both Merck and External Partners.



- Required: BS in chemical/biochemical engineering, pharmaceutical science or chemistry/biology


- Minimum of five (5) years manufacturing experience in the areas of bulk biologics manufacturing and technical transfer or have demonstrated experience in these areas.


- External Manufacturing, Change Control Management, Statistics 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. Our Company’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. If you need an accommodation for the application process please email us at

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Job: Chemical Engineering

Job Title:Sr. Spclst, Engineering

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Kenilworth

Employee Status: Regular

Travel: Yes, 20 % of the Time

Number of Openings: 2

Hazardous Materials: No

Company Trade Name:Merck