Merck Director, Site Pharma Technical Operations in Wilson, North Carolina

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.

Responsibility and S&T Primary Activities

This position requires a highly skilled technical leader in the Technology Transfer, Technology Development and Technical Support areas across each of the complex dosage form platforms (franchises). These platforms include primary and secondary packaging technologies for oral solid dosage forms (tablets, capsules, oral granules), sterile injectables and devices and serialization and aggregation technology. Position manages and leads New Product and/or New Technology Introductions through Commercialization or New Technology program.

Serve as key troubleshooter addressing the wide variety of technical issues and challenges that might arise within the manufacturing environment including in-line product support, productivity initiatives through scientific rigor and inclusion of appropriate technical expertise.

Implementation of visible measures and subsequent creation of plans to demonstrably improve product process robustness and process capability.

Understand current team skills and competencies, define future skills and competencies and develop talent and learning strategy to achieve future state. Have ongoing renewal of this process.

Provide exceptional leadership in all site regulatory inspections through demonstration of exceptional scientific process understanding when presenting investigations.

Support site regulatory inspections through demonstration of scientific process understanding and development of appropriate TO owned GMP systems (Validation, Change Control, etc.). Leadership by the site TO lead in this area is critical for the site inspection success.

Regularly review, measure, modify, and adjust customer service plans and delivery systems to monitor the efficiency, effectiveness and balance of resources according to performance and evolving demands. Supports cost saving initiatives at the site through the current Opportunity Assessment.

Lead and manage the capital project portfolio for the site. Provide support for equipment design, equipment qualification, process demonstration and process- and cleaning validation.

Provide technical leadership and mentorship to all engineering support teams including project-, automation-, reliability- and maintenance engineers.

Organization: The site TO lead will have a critical role in organizational design of the TO role in Integrated Process Teams and the Center of Excellence team. In addition, the site TO lead will foster the maturation of this process at the site and establish the best organization to meet the site's business requirements. This position will provide leadership and coaching and ensure people development is a key focal point.

The Site Pharm Tech Ops Leader will solid line report to the Regional Pharm Tech Ops leader and dotted line to the Plant Manager. The technical leader is a member of the site leadership team and will be involved in site leadership team activities such as site strategy development and refresh, hoshin management and site leadership team tier process. Strong collaboration expected with site leadership team colleagues.

The Site Pharm Tech Ops Leader will typically lead a department of 10 to 20 personnel and is responsible for ensuring the required competencies, talent management and development of people.

The Pharm Tech Ops department is responsible for all aspects of technical process including problem resolution, process improvements, process change control, equipment and process qualification, process monitoring, technology transfers (pipe-line and in-line), process maintenance for pharmaceutical manufacturing and packaging.

Additionally, the Site Pharm Tech Ops Leader will leverage the association with the Regional Pharm Tech Ops Group that provides internal site and external partner support, to collaborate on providing technical support to other internal sites and external partners within the region as a secondary responsibility.

He / She will create the environment in the group for collaboration across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a Boundary less Organization mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing in the flow of the core work.

Education Minimum Requirement: BS, MS or PhD in Engineering, Pharmaceutics, Science or Equivalent

Required Experience and Skills**: 10 years’ pharmaceutical and biopharmaceutical experience post BS.

Preferred Experience and Skills:

Technical Competencies (Core S&T Functional Competencies)

  • Deep Technical Expertise preferred in Pharm and/or packaging. Or in a combination of two or more of the following API, Biologics, Vaccines, Sterile, Engineering, Analytical. A demonstrated track record of applying scientific, technical knowledge and problem solving approaches to deliver business results.

Professional Competencies

Business Acumen and Financial Management:

  • In-depth knowledge of Merck financial systems (budgets, expenses, product standards and variances.)

  • Creates awareness of cost levers from Tier 5 to Tier 1, driving productivity at all levels.

Problem Solving:

  • Gathers and analyzes data and effectively responds to new, complex, or problematic situations; creates solutions that drive value for Merck and our customers, incorporating innovative approaches.

  • Models and teaches scientific problem solving approaches to group and peers.

  • Demonstrates a lean mindset and drives continuous improvement

Project Management:

  • Organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery and right first time by integrating with partner areas.

  • Is an expert on capital project portfolio management.

Strategic Thinking and Working across Boundaries:

  • Thinks and acts beyond one’s silo

  • Bridges boundaries across teams, functions, divisions, geographies, external stakeholders, and customers.

  • Practices and sponsors Inclusive Behaviors and mindsets in the flow of work.

  • Models behaviors consistent with a Boundary less Organization mindset – Right People, Place, and Time.

Productive Communication:

  • Plans and delivers ideas and information to others in a clear and impactful manner.

  • Continuously communicates to align with partners and stakeholders

  • Communicates effectively with direct reports and employees.

Leadership & Managerial

Drive Results:

  • Sets clear performance standards including stretch goals for self and workgroup

  • Overcomes obstacles

  • Holds self and others accountable for achieving results

  • Works proactively to remove barriers to achieving and exceeding goals.

  • Communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders.

Build Talent:

  • Utilizes standard performance management and talent management processes.

  • Build diverse talent within the workgroup with the capabilities necessary for future success.

  • Continuously assess competencies versus future needs and plan to fill gaps.

  • Reward and develop employees to ensure individuals reach their full potential.

  • Makes tough calls when necessary.

  • Ensures 100% of employees have an EDP.

People Management

  • Is an experienced Coach and teacher of people.

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

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

Title: Director, Site Pharma Technical Operations

Primary Location: NA-US-NC-Wilson

Requisition ID: MEC000144