Skip to main content

This job has expired

Director, Elkton Technical Operations Job

Job Details

Director, Elkton Technical Operations-CHE005255

Description

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 Director, Technical Operations will oversee all technical aspects of the realization of a new sterile bulk antibiotic manufacturing facility at Merck’s Manufacturing site in Elkton, VA. This includes qualification of the new facility, transfer of the technology from the existing facility, validating the process, overseeing the regulatory filing and establishing sustainable long term supply practices. The facility is located in Virginia's Shenandoah Valley and opened in 1941. The site employs a wide array of state of the art manufacturing technologies to support the production of pharmaceuticals including API’s, natural products, vaccines, therapeutic proteins and sterile filling operations.

Responsibilities include but are not limited to:

•Compliance:
◦Accountable for compliance with cGMP and Safety, Environmental, Employment, and Industrial Health regulations for processes associated with the facility.
◦Accountable for the CMC section of the associated regulatory filing.
◦Supports atypical investigations, audits and responses to governmental agency requests.
◦Provides technical support during pre-approval regulatory inspection and drives permanent inspection readiness as an integral part of compliance as a competitive advantage.

•People Management:
◦Establishes a team of technical subject matter experts to provide long term technical support to the facility. The technical team provides tactical technical expertise to support process investigations and troubleshooting but also has strategic responsibility for improving the long term reliability and sustainability of our production processes.
◦Directs the activities of, and administratively manages, a highly qualified professional staff of ~10-15.
◦Assumes responsibility for recruiting, onboarding, training and developing our most valuable assets – the people that makes-up the Technical team.
◦Coaches and develops the technical team. Provides input on their professional and career development, timely feedback, and manages performance.
◦Teams with other members of the leadership team to plan and implement talent management of resources.
◦As a member of the leadership team, creates a collaborative and inclusive work environment for all team members.

•Strategy:
◦Accountable for all technical aspects of the commercialization of the new asset. This includes qualification of the equipment, transfer of the process from the existing facility, demonstrating and validating the process in the new facility and the writing and reviewing the CMC section of the regulatory filings in all the relevant markets.
◦Developing and implementing a robust sterility assurance strategy to manage the sterile powder through the facility.
◦Leads and coordinates initiatives to improve reliability, increase throughput, eliminate inventory and reduce manufacturing cost while maintaining a relentless focus on ensuring the safety and efficacy of our products for our patients.
◦Drives the implementation of standard work for technical resources and supports the implementation of visual management systems to enable shop floor level accountability and engagement.
◦Handover of the facility and the process to the Operations team to ensure compliant, cost effective, long term sustainable and reliable supply.

•Financial Stewardship:
◦Responsible for management of the technical team’s operating budget.
◦Assists in the development of the long-term capital plan and management of capital projects associated with the facility.

Qualifications

Education Minimum Requirement:

•BS/MS/PhD in Engineering or Science

Required Experience and Skills:

•Minimum of 10 year experience in providing technical support for pharmaceutical manufacturing
•Technology transfer, new asset realization and start-up experience
•.At least 5 years of direct management experience

Preferred Experience and Skills:

•Knowledgeable of cGMP’s, financial principles, safety guidelines, engineering standards, and regulatory issues.
•Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
•Sterile antibiotic manufacturing facility start-up experience
•Technically proficient and has demonstrated managerial and leadership skills necessary to build and maintain a high-performance group of technical professions.

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 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​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Chemical Engineering

Job Title:Dir, Engineering

Primary Location: NA-US-VA-Elkton

Employee Status: Regular

Number of Openings: 1

Hazardous Materials: No

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert