Principal Scientist, Analytical R&D

Job Description

Our team in West Point, Pennsylvania, in the Vaccine Analytical Research & Development department is seeking a Principal Scientist who is passionate about developing analytical solutions that enable and accelerate process and product development and manufacturing while ensuring product safety and quality.

This Principal Scientist role will support analytical method development within the High-throughput analytical team and act as a strategic partner across our Bioprocess, Formulation, Analytical, and Discovery teams, advocating the adoption of various automation systems to enhance efficiency, speed, and capacity. In this lab-based role, the candidate will focus on designing analytical strategies to develop high-throughput methods for vaccine characterization and to support process and product development.

Duties may include developing immune-based antibody-binding assays (ELISA), viral infectivity cell-based assays, and other classic biochemistry-style methods. The role also involves supporting method qualification and validation, preparing GxP documents, troubleshooting equipment, transferring methods between automated platforms, and functioning as an assay/program lead.

Some of the main responsibilities include:

• Providing scientific, automation, and operational strategy across teams responsible for developing high-throughput methods for vaccine process development and clinical manufacturing.

• Provides mentorship, technical oversight, and strategic guidance to employees.  Potentially manages a small group of individual contributors or analytical projects.

• Represent the functional area in cross-functional and strategic teams engaged in novel vaccine development. Coordinate with internal digital technology teams to assist in translating automation designs into operational, user-ready solutions.  Actively interacts with internal and external counterparts.

• Authors required regulatory and technical documentation. Ensure that process/products are developed and documented according to our company's standard practices.

• Maintain a strong internal and external network and engage effectively with automation vendors and regulatory stakeholders, while promoting a culture of scientific excellence.

• Establishing future automation and operational strategies while incorporating new technologies into the laboratories.

Education Minimum Requirements:

• Ph.D. in analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 8 years of relevant experience; OR M.S. with a minimum of 10 years of experience; OR Bachelor's with a minimum of 15 years of experience in the Pharmaceutical Industry.

Requirements:

• Demonstrated expertise in analytics for a wide variety of large molecules, including recombinant proteins, virus-like particles, and viral vaccines. Specializing in assay development within an automation-focused team, with a proven track record in assay lifecycle, including validation and transfer, to support clinical release of vaccines.

• Strong understanding of automation technologies and experience developing and implementing laboratory automation strategies.

• Expertise in driving technological advancements to improve efficiency and productivity through both physical laboratory automation and digital strategies. Knowledge to align these strategies with pipeline/business objectives and identify opportunities for implementation. 

• Demonstrated ability to collaborate with stakeholders, including scientists and IT/technology experts, to ensure workflow/digital solutions meet business needs and requirements.     

• Advocated for the adoption of automation and operational excellence in high-throughput analysis through effective management of resources and instrumentation, by prioritizing testing requirements, fostering collaboration, and sharing a comprehensive vision for training and development across a diverse talent pool.

• Ability to manage a portfolio of projects effectively and multitask in a highly dynamic environment, and influence cross-functional teams in a professional and positive manner.

Preferred Experience and Skills:

• Proven ability to direct the development of new, innovative approaches, demonstrated by experience with new assay or robotic technology evaluation and shaping scientific strategy at both the platform and program level.

• Excellent verbal and written communication skills and an ability to excel in a team-based environment.

#AR&D

Required Skills:

Analytical Chemistry, Analytical Chemistry, An