Distinguished Scientist, Analytical R&D Full-time

Distinguished Scientist

The Distinguished Scientist within our company's Vaccines Analytical Research & Development organization (V-AR&D) is accountable for providing scientific research direction and will partner with the executive management team to refine and advance the strategic directions for our Vaccines portfolios. The ideal candidate should be a visionary with extensive experience in human vaccine process and analytical development and be adept at independently directing research and scientific problem solving. They should have demonstrated commitment towards advancing Vaccines products through innovation, strategic decision making, and partnership with Manufacturing, Quality, and Regulatory Affairs.

In this role, they will be responsible for steering scientific strategy and policy with broad pipeline oversight. As a scientific leader, they will partner with the respective leadership teams to drive innovation, scientific excellence, and advance strategic initiatives including due diligence activities.

Primary Responsibilities:

• Leveraging experience working on many types of human vaccine candidates, drive an End-to-end Integrated Control Strategy for new programs
• Build an innovative and strategic scientific vision for the Analytical Research and Development teams through strong scientific leadership.
• Anticipate Analytical opportunities proactively, including acting as a key interface for collaborating departments.
• Serve as technical lead for setting specifications and responding to regulatory feedback.
• Drive Adjuvant strategy through partnership with Strategy and Development teams
• Advocate and sponsor evaluation of progressive methodologies, driving implementation to the development and commercialization space.
• Accountable for mentoring the next generation of scientific talent. Serve as a role model and scientific mentor to the department and cross-functional collaborators, with responsibility to develop scientific talent aligned with organizational strategy.
• Maintaining recognition as an internationally known expert in their field through regular publication in peer reviewed journals and participating actively in scientific meetings, including chairing sessions. May serve on expert committees outside our Company, on editorial boards, planning committees or major scientific meetings.
• Interface with Discovery interface teams to ensure scientific rigor and strategy for FIH studies
• Apply principles of predictive stability across the vaccine portfolio.
• Interface with Manufacturing teams to proactively guide method transfers and serve as POC for any troubleshooting
• Own Analytical Cross-functional Forum, setting agenda and driving collaboration across the various interfaces
• Lead Vaccines Analytical Tier Escalation, highlighting wins and areas of current concern to management with the appropriate level of details.

Education:

Bachelors, Masters, or Ph.D. in biochemistry or other related field with 20+ years of product development experience

Required Experience and Skills:

The Distinguished Scientist should demonstrate effectiveness in the following key dimensions:

• Strong experience in Process Development and a willingness to apply learnings to develop relevant Analytical methods
• Commercialization and licensure of human vaccines products.
• Strong experience in applying separations techniques and high-throughput automation in process development in a phase-appropriate manner.
• Provides strategic scientific influence, originates and develops new project/program ideas. Contributes expertise and creativity to the collective knowledge and aids in solving complex pipeline problems.
• Recognized as a scientific expert, strongly influences senior leaders and helps steer scientific strategy and policy.
• Recognized nationally/ internationally for scientific expertise in large molecules.
• Demonstrated experience in Phase Appropriate Validation, data trending, and biological critical reagents used in validated methods.
• Dynamic mentorship and scientific direction to develop scientific excellence in the team. Strong role model, coach and mentor of junior scientists.
• A track record of consistently delivering innovations and implementing novel approaches to impact across the pipeline.
• Interest and experience to adopt and integrate automation and data sciences/machine learning solutions.
• Demonstrated ability in steering scientific strategy
• Incumbent must have excellent interpersonal, communication, and collaboration skills.

Location: West Point PA, with < 10% travel to other Research and Development sites.

Required Skills: Accountability, Analytical Chemistry, Analytical Method Development, Business Decisions, Cell-Based Assays, Collaborative Communications, Communication, Cross-Cultural Awareness, Cross-Functional Teamwork, Data Science, Dosage Forms, Exercises Judgment, Foster Innovation, Innovation, Instrumental Analysis, Intellectual Curiosity, Management Process, Mentorship, Molecular Structure, Process Builders, Process Engineering, Product Development, Production Process Development, Professional Networking, etc.

Required Skills: Accountability, Analytical Chemistry, Analytical Method Development, Business Decisions, Cell-Based Assays, Collaborative Communications, Communication, Cross-Cultural Awareness, Cross-Functional Teamwork, Data Science, Dosage Forms, Exercises Judgment, Foster Innovation, Innovation, Instrumental Analysis, Intellectual Curiosity, Management Process, Mentorship, Molecular Structure, Process Builders, Process Engineering, Product Development, Production Process Development, Professional Networking, etc.