Associate Director GTO Biologics Projects

West Point, PA, US
April 17 2018
Organization Type
Requisition ID: CHE005908

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 Unitat Merck is undergoing significant growth of the Keytruda franchise due to itsmajor impact in cancer therapy.  Also,further growth is anticipated as a result of existing and pipeline biologicsproducts.  The Global TechnicalOperations (GTO) Biologics Technology department vision is to be a world-classscience based organization in technology transfer and technology services insupport of worldwide biologics manufacturing. As a member of the GTO Biologics Projectteam, the Associate Director will beresponsible for defining and leading projects and initiatives intended totransform GTO Biologics into a World Class service organization and to impactthe transformation of the broader Biologics Operating Unit.  The incumbent will operate with a high degreeof independence, assuring alignment with appropriate functional leaders andstakeholders while advancing their assigned projects and initiatives.  The incumbent will have interest andcapability in rigorous scientific approaches, operational excellence and sixsigma methods, systems development and change execution management, and stronganalytical, communication and interpersonal skills. 

The incumbent must have biologics orvaccines manufacturing experience and strong leadership, project management,analytical and interpersonal skills, as well as business acumen.  The Associate Director may also be involvedin technology transfer and technology support activities (including technologytransfers to and from External Partners and manufacturing process support toExternal Partners to resolve production issues and to support processoptimization). 

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 supportThe 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  escalationDevelopment and operation of a project portfolio management system for Biologics ProjectsLeader and/or team member for one or more area in the development of internal biologics manufacturing network and/or facility of the futureDirect 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 includeCommunication and oversight of assigned External Partner technical issues.Technology transfer for process changesProvide technical support to External Partners to resolve manufacturing issues and investigationsIn 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 acumenDemonstrate skill in project management and developing and leading high performing teamsDisplay Merck leadership behaviors and demonstrate a high emotional intelligenceFunction 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.Qualifications

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

Required Experience and Skills**:  

Minimum of 10 years manufacturing or development (including technical transfer) experience in the areas of bulk biologics or vaccines  Technical expertise in the development or support of bulk biologics or vaccines processes (upstream and/or downstream unit operations)Demonstration of Merck Leadership StandardsUnderstanding of statistics applied to process monitoring and controlInterest and a proven track record of managing and leading projects Ability to use Microsoft Project softwareStrong business acumen, communication and interpersonal skills Ability to communicate with external partnersAbility to collaborate across functions and geographiesAbility to maintain strong working relationships with technical, quality and operations leaders in the internal and external network
Preferred Experience and Skills: 
  • Bulk biologics/vaccine facility start-up and/or design experience
  • PhD in chemical/biochemical engineering Team member/leader for projects 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. 
    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement

    Job: Chemical Engineering
    Other Locations:
    Employee Status: Regular
    Travel: Yes, 10 % of the Time
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck

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