Merck Associate Director, Gardasil Expansion Fermentation Technical Lead in Elkton, Virginia
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 Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
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, Gardasil Expansion Fermentation Technical Lead position available. This role will be responsible for site operational readiness activities for a new biologics / vaccine manufacturing facility.
The Fermentation Technical Lead will work with the operations and project engineering teams supporting facility design, factory and site acceptance testing, commissioning/qualification, and validation, and the facility startup and ramp to support commercial demand in the new manufacturing facility. The Fermentation Technical Lead will be the primary “technical 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 Fermentation Technical Lead will also be responsible for the recruitment, onboarding and training of the engineering staff 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 Fermentation Technical Lead will be responsible for performing the following tasks (as the project progresses towards startup), but not be limited to:
Managing and mentoring teams
First responder and incident command leadership
Partnering with Operations, Maintenance and Reliability to resolve technical issues quickly
Safety Management Systems (Enablon),
Active participation in Hazop and Safety walk throughs, and leadership at Tier 1 and Tier 2 level meetings
Education Minimum Requirement:
- B.S. or higher in Science or Engineering related degree
Required Experience and Skills:
Minimum of eight years of project and/or manufacturing 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.
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
Meeting Facilitation/Training/Presentation Skills
Planning, Implementing, Directing, Control, Decision Making
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.
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Job Chemical Engineering
Title: Associate Director, Gardasil Expansion Fermentation Technical Lead
Primary Location: NA-US-VA-Elkton
Requisition ID: CHE006638
- Merck Jobs