Senior Specialist GTO Biologics Projects
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.
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 Senior Specialist will be primarily responsible for leading and supporting projects intended to transform the Biologics Technology support function and the Biologics Operating Unit in order to deliver value to Merck’s patients. These projects include but are not limited to: development of the internal manufacturing network and facility of the future, development of technical standards, process analytics and control, technical capability building/training, and the implementation of knowledge manag
The incumbent will have interest and capability in biologics processes, rigorous scientific approaches, standardization of systems, and application of analytical and operational excellence principles.
The incumbent must have biologics or vaccines manufacturing experience and strong leadership, project management, analytical and interpersonal skills, as well as business acumen. The Senior Specialist may also be involved in technology transfer and technology support activities (including technical 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 support
- Receives direction for some projects from the Associate Director Biologics Projects or other project leaders
- Leads or participates in the execution of the projects
- Functions independently or as part of a team to develop project charters and project plans and align with all sponsors and stakeholders. Key capabilities include standard project management activities: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification. tracking and mitigation.
- Utilize six sigma and operational excellence approaches to develop and design solutions to support the execution of Biologics projects
- Coordinates and tracks team activities by leading or participating in core team meetings
- Communicates project risks and status to appropriate stakeholders
- Escalates issues to sponsors as needed in advance of deviation from project plans
- As needed, the Senior Specialist may also support technology transfer or technical support for in-line manufacturing. These activities include but are not limited to:
- Communication and oversight of assigned External Partner technical issues.
- Support technology transfer activities
- 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 leading teams effectively
- 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, chemistry/biology or similar discipline
Required Experience and Skills:
• A minimum of 4 years manufacturing or technical support in the areas of bulk biologics or vaccines manufacturing and/or technical transfer.
• Strong technical understanding of upstream and/or downstream processing in vaccines or biologics
• Interest in managing/leading projects and experience executing projects
• Skill and understanding of project management principles and tools
• Strong business acumen, communication and interpersonal skills
• Demonstration of Merck Leadership Standards
• Ability to collaborate across functions
Preferred Experience and Skills:
• Bulk biologics/vaccine facility start-up experience
• Understanding of statistics and application to process monitoring and control
• Technical expertise in the development or support of bulk biologics or vaccines processes (upstream and/or downstream unit operations).
• Demonstrated ability in successfully leading and managing projects.
Our 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
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck