Principal Scientist, Analytical R&D Full-time NEW

Principal Scientist

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. We deliver robust scientific data and interpretation that drives the development and commercialization of breakthrough therapeutics. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

The Analytical Research and Development, Cell Based Sciences Department in West Point, PA is seeking a Principal Scientist with technical expertise in developing large molecule potency assays. In this role, an individual will work closely with the group Director to define technical and scientific strategies and lead a team of scientists in solving complex analytical problems to facilitate the development of vaccines. The ideal candidate will be an expert in developing mechanism-of-action reflective potency assays for the development of multi-valent recombinant vaccine products. We are looking for a collaborator with strong leadership skills and ability and passion for mentoring and working with others in a laboratory setting. This position will involve leading laboratory development to drive understanding of vaccine development, partnering across functions and divisions to strategically apply that understanding to deliver the best analytical science in the process and product will be key to success.

The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior written and oral communications skills. The candidate will be expected to effectively communicate with stakeholders in partner organizations and to management and governance teams. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected.

Primary Responsibilities:

• Lead, supervise, and mentor a team of scientists developing analytical methods and defining the potency strategy for our large molecule portfolio.
• Provide analytical leadership not only on vaccine development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future.
• Represent the group on product development teams, work and collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions.
• Lead in authoring and reviewing scientific documents including development reports, analytical method protocols, qualification protocols, and electronic notebooks.
• Be a leader within the external scientific community in professional organizations, conferences, and publications as well as analytical technology and regulatory sciences related focus groups and consortia.

Education Requirements:

• Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of eight years of relevant experience in Biopharmaceutical Industry; OR
• M.S. with a minimum of ten years of relevant experience in Biopharmaceutical Industry; OR
• Bachelor's with a minimum of fourteen years of relevant experience in Biopharmaceutical Industry.

Required Skills and Experience:

• In-depth 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 immunology, with application to solve complex scientific challenges related to designing and developing GxP potency assays to support a variety of vaccine modalities.
• Demonstrated ability to lead complex experimental design and detailed data analysis concepts related to analytical method development.
• Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.
• Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.
• 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.
• Excellent verbal and written communications skills.

Please note that this lab-based role is not eligible for our hybrid work model, but we are committed to promoting work-life balance and offer other flexible arrangements where feasible.