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Executive Director, Discovery Interface & New Platforms

Employer
Merck & Co.
Location
Greater Philadelphia, Pennsylvania
Start date
Jun 5, 2024

We are seeking an esteemed leader in the process development and manufacturing of vaccine drug substances (DS) as an Executive Director for Discovery Interface & New Platforms (DINP), located in West Point, PA.

 

Our department (Vaccines and Advanced Biotechnologies, VAX) Process R&D is responsible for the development and clinical manufacturing of DS and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS process development and clinical manufacturing for all of our company's pipeline. 

 

The Executive Director will be responsible for interfacing with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology. This individual will play a pivotal role in advancing our pipeline and establishing scientific excellence by adopting new modalities and cutting-edge technologies.

Additionally, the role encompasses enhancing our external collaboration network (academia, industry, and NGOs), and guiding our scientific presence externally through publications and leading conferences.

The individual will report directly to the Associate Vice President, of VAX Process R&D and will be expected to represent the group on certain capacities, including but not limited to due diligence, regulatory input, and program leadership. The role will also necessitate the development of scientific talents and high-performing teams from a diverse background and advance our company's commitment to a diverse and inclusive work environment.

 

Responsibilities:

 

Discovery interfacing

  • Establish early and robust interfaces with related Discovery organizations such as Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology.

  • Engage early in pre-clinical space to influence antigen and molecule design, build developability and manufacturability from the origin, and accelerate pipeline to PCC and FIH as needed.

Innovation and Pipeline Advancement

  • Rapidly adopt new modalities in the early Discovery stage or from licensed-in assets.

  • Establish phase-appropriate new platforms to facilitate pipeline progression and scientific excellence.

  • Drive pipeline advancement and innovation through proactive collaboration with internal and external organizations

 

Scientific Excellence

  • Establish scientific excellence for new modalities and early assets.

  • Build world-class Nucleic Acid platforms, including DNA, mRNA, and circular RNA.

  • Build state-of-the-art tools for process understanding and robustness, including Systems Biology.

 

Education:

  • PhD in biochemistry, biochemical engineering, pharmaceutical sciences, or a relevant field.

 

Required Experience and Skills:

Business and Technical Expertise

  • A minimum of 12 years of experience in Discovery or DS process development for vaccines/ biologics, with exposure to all stages and aspects of the product life cycle

  • Solid record of interfacing with Discovery organizations in infectious diseases and other therapeutic areas (oncology, neuroscience, immunology etc.) for target validation and proof of biology.

  • Solid skills and experience in antigen/antibody design, including protein engineering and protein modelling.

  • Solid skills and experience in modality/ host selection, matching selected target with suitable modalities and expression systems.

  • Demonstrated capability and track record of applying Systems Biology to advance pipeline.

  • Solid track record of direct Chemistry, Manufacturing, and Controls (CMC) leadership leading to multiple successful Phase 1 regulatory submissions for vaccines/biologics.

Leadership and Impact

  • Demonstrated leadership and communication capability to strongly influence senior leaders across functional areas and steer strategy and execution.

  • Demonstrated expertise in addressing complex challenges in pipeline and life cycle management through critical thinking, innovation, scientific rigor, and cross-functional collaboration.

  • Demonstrated capability and organizational intelligence to lead changes under complexed and ambiguous situations.

  • Solid track record of building high performance team to advance complexed pipeline and technology development.

  • Must be recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise. 

 

Preferred Experience and Skills:

  • Extensive experience in upstream, downstream, analytical development, and continuous manufacturing for vaccines/biologics, with in-depth domain knowledge in one of these areas.

  • Proficient with major cell substrates (E.coli, yeasts, HEK293, Vero, CHO, etc) and modalities (LVV, viral vectors, RNA, protein subunits, conjugates, etc).

  • Strong knowledge of global regulatory requirements for vaccines

  • Working knowledge on DPI and adjuvant development and innovation.

  • Consistently delivers breakthrough results aligned with business needs and advancing the field.

 

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