Requisition ID: CHE006584
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.
I. GENERAL SUMMARY
A Director for the new product feasibility technical areas that manages new product design and assessment, tactical and strategic process, process validation and qualification, licensure and filing, and human resource activities while ensuring optimized product quality and manufacturing processes, regulatory compliance, employee and environmental safety, integration of new/existing technologies, customer service, resource utilization, financial performance and fiscal stewardship.
The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.
II. GENERAL PROFILE
- Provides leadership and direction through managers and individual contributors (professional employees)
- Accountable for the performance and results of a department
- Executes functional business plans and contributes to the development of group or country strategies
- Priorities based on departmental budget and profit plan to address resource and operational challenges
- Decisions are guided by group or country strategies and policies
- Leverages relationships with key clients and/or customers to support business needs
II. PEOPLE MANAGEMENT
- Leads Technical team for the new product feasibility organization, including associate directors, coaches, technicians and engineers (30-40 people)
- Serves a leadership team member for new product feasibility organization
- Coaches/mentors direct reports responsible for each area within Technical
III. FINANCIAL MANAGEMENT
- Responsible for the Technical cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year
IV. PROJECT MANAGEMENT
- Responsible for all process related projects, including funding, change control, validation and qualification
- Responsible for process monitoring, daily technical support and troubleshooting and deviation management
V. SHUTDOWN MANAGEMENT
- Responsible for assisting with shutdown execution including all technical projects and associated change requests
- Coordinates with Durham Site Engineering and Technical CoE
- Attends daily shutdown meetings ensuring activities are tracked and completed
VI. TECHNICAL SUPPORT
- Responsible for the daily support of all production processes to ensure area safety, compliance, production and financial goals are met
- Responsible for establishing processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities
- Manages equipment location and status in SAP as well as related equipment drawings.
- Responsible for all deviation investigations
- Collaborates with Engineering and Automation for maintenance and troubleshooting equipment
- Provide technical/team support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
- Lead technical studies and author documentation associated with site commercialization efforts
- Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects
- Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)
- Collaborate with internal/external partners, e.g. Other Merck sites, Procurement, Raw Material & Component Suppliers
- Develop effective data analytics methodologies, including statistical process control, deepening process understanding
- Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
- Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.
- Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
- Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements
- Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
VII. WORKING RELATIONSHIPS
- Reports to Executive Director, Site Facility Lead
- Manages and interacts with employees within own department
- Frequent interaction with employees from other departments
- Interacts with representatives from regulatory agencies
- Interacts with external suppliers
Education Minimum Requirement:
- Bachelor Degree in Engineering, Science or related field
Required Experience and Skills:
- Minimum 10 years of experience in a production and/or calibration and/or maintenance background (8 Years with a Masters Degree or MBA : 5 years with a PhD)
- Minimum 2 years people management experience
- Strong planning, scheduling, and time management skills
- Working knowledge regulatory requirements in accordance with GMP manufacturing operations
- Good oral and written communication skills
- Project management, including change control, validation and equipment qualification
Preferred Experience and Skills:
- PhD, Masters Degree in in Engineering, Science or related field
- Experience with tech transfer activities and regulatory inspections
- Experience with GMP compliant calibration and maintenance databases
- SAP and Trackwise experience related to deviation management and change control
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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Visa sponsorship is not available for this position.
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Job: Chemical Engineering
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh