Merck Associate Director GTO Biologics Projects in West Point, Pennsylvania

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.

The Biologics and Sterile Operating Unit at Merck is undergoing significant growth of the Keytruda franchise due to its major impact in cancer therapy. Also, further growth is anticipated as a result of existing and pipeline biologics products. The Global Technical Operations (GTO) Biologics Technology department vision is to be a world-class science based organization in technology transfer and technology services in support of worldwide biologics manufacturing. As a member of the GTO Biologics Project team, the Associate Director will be responsible for defining and leading projects and initiatives intended to transform GTO Biologics into a World Class service organization and to impact the transformation of the broader Biologics Operating Unit. The incumbent will operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives. The incumbent will have interest and capability in rigorous scientific approaches, operational excellence and six sigma methods, systems development and change execution management, and strong analytical, communication and interpersonal skills.

The incumbent must have biologics or vaccines manufacturing experience and strong leadership, project management, analytical and interpersonal skills, as well as business acumen. The Associate Director may also be involved in technology transfer and technology support activities (including technology transfers to and from External Partners and manufacturing process support to External Partners to resolve production issues and to support process optimization).

Activities for this position include:

  • Reports to Director, Global Technical Operations Biologics Projects, and receives direction on department strategy, goals and objectives as well as career mentoring and development plan support

  • The Associate Director will use standard project management approaches and assemble and lead teams in the execution of projects with responsibility for resourcing, charter development, project planning and tracking, risk management, and escalation

  • Development and operation of a project portfolio management system for Biologics Projects

  • Leader and/or team member for one or more area in the development of internal biologics manufacturing network and/or facility of the future

  • Direct working teams in the development of technical standards and technical capability building, while integrating these efforts with knowledge management initiatives.

  • As needed, the Associate Director Biologics Projects may also support technology transfer or the resolution of manufacturing issues throughout the network. These activities include

  • Communication and oversight of assigned External Partner technical issues.

  • Technology transfer for process changes

  • Provide technical support to External Partners to resolve manufacturing issues and investigations

  • In concert with Commercialization, Quality, and Regulatory, support inspection readiness for new product introductions and transfers.

  • Develops and executes validation strategies for new and existing products.

Importantly, the individual must:

  • Provide strong leadership and demonstrate business acumen

  • Demonstrate skill in project management and developing and leading high performing teams

  • Display Merck leadership behaviors and demonstrate a high emotional intelligence

  • Function with high degree of independence to develop and achieve concurrence on approaches for the various assigned initiatives. This includes development of approaches, options analysis, and alignment with stakeholders on project charters and project plans.

  • Collaborates with internal stakeholders and external partners as needed to achieve business goals.

Education Minimum Requirement: Qualified candidates must have a BS in chemical/biochemical engineering, pharmaceutical science or chemistry/biology or related sciences

Required Experience and Skills ** :

  • Minimum of 10 yearsmanufacturing or development (including technical transfer) experience inthe areas of bulk biologics or vaccines

  • Technical expertise in thedevelopment or support of bulk biologics or vaccines processes (upstreamand/or downstream unit operations)

  • Demonstration of MerckLeadership Standards

  • Understanding of statisticsapplied to process monitoring and control

  • Interest and a proven trackrecord of managing and leading projects

  • Ability to useMicrosoft Project software

  • Strong business acumen,communication and interpersonal skills

  • Ability tocommunicate with external partners

  • Ability to collaborate acrossfunctions and geographies

  • Ability tomaintain strong working relationships with technical, quality andoperations leaders in the internal and external network

Preferred Experience and Skills:

  • Bulk biologics/vaccinefacility start-up and/or design experience

  • PhD in chemical/biochemicalengineering

  • Team member/leader forprojects involving interactions with external partners

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

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

Title: Associate Director GTO Biologics Projects

Primary Location: NA-US-PA-West Point

Requisition ID: CHE005908