Executive Director, Immunogenicity and Molecular

Chalfont, PA

Our Development team ensures production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.


The Executive Director, Immunogenicity and Molecular guides the Preclinical Development (PCD) Immunogenicity and Molecular Biology Bioanalytics group with overall responsibility for method development, validation, and implementation of immunogenicity/ molecular biological assays as primary endpoint and/or safety assays for Vaccines and cell-based Biologics development, including preclinical safety, clinical studies and post-marketing studies.


Responsible for conducting bioanalytical work to a high level of quality and rigor, ensuring compliance with regulatory guidance, and for preparation of high-quality regulatory submissions. Provides strategic direction and leadership for staff, builds strong teams, attracts and develops diverse staff. Provides technical oversight of external development and implementation of regulated immunogenicity and molecular biology assays.


Education:

  • Ph.D., in Biochemistry, Molecular Biology, Microbiology, Analytical Chemistry or a related discipline with minimum of 15 years of bioanalytical or related experience, including Bioanalytical assay development and/or application of bioanalytical assays for clinical testing, in drug and/or vaccine development; an M.S Degree would need to demonstrate commensurate accomplishments.


Required Experience and Skills:

  • Demonstrated expertise in immunogenicity, molecular biology, method development, clinical assays, and analysis of biologics and vaccines is very desirable together with excellent knowledge of how this information is used in preclinical, clinical development and post-licensing studies including concomitant testing/ combination studies.
  • Experience in interactions with regulatory agencies is required with demonstration of successful bioanalytical strategies.
  • Demonstrated leadership and management experience in the area of regulated bioanalytics.
  • A track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations
  • Ability to set and deliver on current and future strategies


Preferred Experience and Skills:

  • Direct project support and an understanding of how immunogenicity data impact critical decisions. Someone with a background in robotics, laboratory information management systems, and information technology, is also desired.
  • Demonstrated ability to improve end-to-end lean streamlined processes is beneficial.


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 


Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.


What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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