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Director, Vaccine Process Development and Commercialization job in West Point

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Merck & Co. jobs
Pennsylvania (PA), West Point
Job Code:  PRO017685
Employer:  Merck & Co.
Category:  Process Development

Location
Country:  United States
State:  Pennsylvania (PA)
City:  West Point
Map: 
09/14/2018

Description
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 Vaccine Process Development and Commercialization (VPDC) group within the Merck Manufacturing Division (MMD) focuses on late stage development and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong technical skills to lead, develop, and mentor a team of scientists and engineers in the development, technology transfer, and commercialization of multiple programs. This position has two main components, drug substance program leadership and coordination, and technical process development and characterization.

As a strategic drug substance technical and program team leader, you will help develop the overall drug substance strategic vision for one or more programs. This vision will optimize time-to-market and efficiency, which you will translate into the Drug Substance section of the Integrated Development and Supply Plan. While playing a key role in leading the execution of that plan, you will represent VPDC as a key member of the Integrated Development and Supply Team and partner with VPDC functional area leads to ensure that all work streams meet the goals set forth by the Integrated Development Supply Team and senior leaders from MMD and Merck Research Labs. You will collaborate with multiple drug substance work stream leads to develop project schedules, establish clear priorities, and establish and monitor metrics to gauge team progress, performance and results. This role may also require leading some of these work streams.

You will closely interface with technical teams in the execution of vaccine development, in-process characterization, commercialization, life cycle management, and investigations. This work may involve multiple sites including outsourced providers, and will involve multiple programs within a franchise. You will interface closely with process, formulation, analytical, manufacturing, quality, and regulatory groups to develop long-term strategies and product trajectories. Additionally, you will interact with senior leadership, outsourced organizations, and health authorities.

We seek someone with exceptional communication and interpersonal skills who can engage the Merck network to collaboratively and effectively advance critical activities against timelines. As a critical aspect of this role, you will teach, mentor, coach, and provide technical guidance in support of employee development. You will focus on expanding and evolving our culture of continuous learning and improvement through employee empowerment and growth. Through its people, you will find innovative ways to build our group into a world-class process development and commercialization team.


• B.S. in Chemical Engineering, Bio engineering, Biochemistry, Chemical Biology , or related field with 15 years of relevant experience; or Master's degree with 12 years of relevant experience; or PhD with 10 years of relevant experience. PhD is desirable.
• Minimum of (10) years large molecule (upstream or downstream) process development, technical operations, or manufacturing operations experience
• Minimum of (5) years commercialization or technology transfer experience in vaccines or biologics
• Minimum of (5) years large molecule analytical and/or in-process characterization experience
• Knowledge and in-depth experience with site operations and technical transfers
• Ability to drive complex programs through multiple teams in the context of long-term commercialization plan
• Expertise in large molecule drug substance unit operations including two or more of the following: fermentation, lysis, normal and tangential-flow filtration, chromatography, continuous centrifugation, precipitation, and conjugation chemistry
• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development
• Experience with long-term strategic planning
• Outstanding communication and people skills
• GMP experience
• Advanced computer skills using MS Office Suite (Outlook, Word, Excel, Power Point etc.), statistical packages and operation of other peripheral devices Preferred Experience and Skills:
• Large molecule process development expertise with multiple vaccine or biologics platforms including: recombinant protein, live viral, polysaccharide, or conjugate
• Strong understanding of regulatory filing requirements (IND, MAA, BLA) with multiple agencies (FDA, EMA, JNDA, TGA)
• Subject matter expert in due diligence activities
• Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles

MMDHJ
ref: (PRO017685)
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