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Associate Director, Operations Job Elkton United States,  

MSD (company)

Posted on : 10 April 2017

Project Description

Associate Director, Operations-PRO015275


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.

At Merck s Manufacturing Facility in Elkton, Virginia we currently have an Associate Director, Operations position available. This role will be responsible for site operational readiness activities for a new biologics / vaccine manufacturing facility.

The Site Readiness Lead will work with the technical and engineering teams supporting facility design, equipment startup, process and area qualification, SOP and training development, process validation, and the training and development of the operating staff to support commercial demand in the new manufacturing facility. The Site Readiness Lead will be the primary Operations voice  in design reviews for the engineering phase of the project. They will also be responsible for performing and participating in safety, environmental, and quality reviews.

The Site Readiness Lead will also be responsible for the eventual recruitment, onboarding and training of the Operations staff (Salary and Unionized) required to run the facility during start-up and routine production. They will ensure Right the First Time execution per standard operating procedures and in compliance with Good Manufacturing Practices (cGMP s), safety, and environmental regulations. Due to the high impact nature of this role it is essential that the incumbent demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same.

The Site Readiness Lead will be responsible for performing the following tasks, but not be limited to:

"Coaching and mentoring teams
"First Responder interviews for Level 3 Human Error related QN s,
"Line clearance lockout/tagout and permit writing,
"Safety Management Information Systems (SMIS),
"Daily Safety Check Sheet/Walkabout, actively lead the Tier 1 Process and participate in Tier 2
"Coordinate the activities of multi discipline employees (CT s, Mechanics, EC Techs, FSW, and Operators), SAP Triage, adherence to team performance and standardized work, and the ability to direct mechanics when needed.


Education Minimum Requirement:

" B.S. in Business, Science or Engineering with minimum of six years of manufacturing experience

Required Experience:

"Work experience in cGMP (monoclonal antibodies, biological, sterile, vaccine, pharmaceutical environment).
"Supervisory experience (salaried and/or Union direct reports)

Preferred Experience and Skills:

"Experience in new manufacturing facility design / construction / start-up
"Leadership and interpersonal skills to motivate direct reports and peers to excel and "own" the process
"Experience from other manufacturing industries and disciplines
"Excellent communication and organizational skills
"Flexibility to perform various tasks to support the business.
"Toyota Production System (TPS), Lean, Six Sigma, KATA problem solving skills
"Ability to prioritize, align and simply to focus on and obtain business results
"Previous experience training individuals in complex manufacturing / work environments
"Delta V, Provox and SAP experience is a plus
"Ethics and Integrity
"Management Relationships (Union experience a plus)


Elkton, VA, US

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