Associate Principal Scientist, AR&D

Job Description

Our Scientists are our Inventors. We deliver robust scientific data and interpretation that drives the commercialization of breakthrough therapeutics using innovative thinking, state-of-the-art facilities, and modern equipment. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing your career.

The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a motivated Associate Principal Scientist with technical expertise in developing large molecule potency assays. The Vaccine Potency team is a laboratory-based scientific and technical group tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Vaccine clinical candidates.

The primary role of the successful candidate will be to lead the design, method development, optimization and technical transfer of mechanism-of-action reflective potency assays for the development of multi-valent recombinant vaccine products. The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. The candidate will be expected to effectively communicate with stakeholders in partner organization and to management and governance teams.

The successful candidate should cultivate and foster scientific and technological innovation, leverage external networks to stay current on industry best practices and emerging technologies in potency assay development, champion new initiatives, and seek to enhance functional capability and operational excellence.

Education Requirements:

• Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of 6 years of relevant experience.

• OR Master’s degree with a minimum of 10 years of relevant experience.

• OR Bachelor’s degree with a minimum of 12 years of relevant experience.

Required Skills and Experience:

• Knowledge and understanding of immunoassay development including antigen and antibody selection, antibody matched pair screening and optimization, binding kinetics, and multiplexing.

• Expertise in cell biology and/or immunology, with application to solve complex scientific challenges related to designing and developing GxP potency assays to support a variety of vaccine or biologic modalities.

• Hands on experience with development of immunoassays and proficiency in a variety of biological and immunological techniques such as ELISAs and binding assays.

• Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics.

• Proficiency in common bioassay software and data analysis packages (e.g., SoftMax Pro, JMP, Design Expert).

• A strong team player with excellent oral and written communication skills; independently design, execute and troubleshoot experiments; and analyze, interpret, and clearly communicate complex analytical data.

• Experience in representing analytical functional area on cross functional project teams.

• Authoring and reviewing internal technical reports and/or sections of regulatory filings (e.g., RTQ, IND, BLA).

• External scientific engagement demonstrated through publications, regulatory guidance documents, industry white paper contributions, presentations at scientific meetings, and/or membership on (or leading) cross-company working groups or consortia.

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