Associate Principal Scientist, Molecule Analytical Research and Development

Overview

Associate Principal Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development (SMAR&D) group has an opportunity for an Associate Principal Scientist based in Rahway, NJ. Join us and experience our culture—strong ethics & integrity, diversified experiences, exceptional science, and a passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will collaborate with talented colleagues while developing and expanding your career.

• Lead or participate on analytical teams driving the development of drugs in the Company pipeline with an understanding of product development from early stage through commercialization.
• Actively partner with other functional areas to design scientific studies guiding product and process development.
• Define and implement end-to-end analytical control strategies for clinical supplies under good manufacturing practices, including method development and validation as well as specification setting.
• Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/worldwide marketing application (WMA) submission documents across the project development lifecycle, and respond to agency questions.

• Promote scientific excellence and regulatory influence through leadership in the scientific community.
• Advance and expand analytical capabilities via adoption and implementation of novel technologies for product and process characterization.
• Design and execute experiments to influence programs with data-driven decisions.

• Mentor and provide day-to-day oversight of junior analytical scientists.
• Represent the team or department via presentations to governance committees and other internal audiences.
• Proactively identify and escalate program risks.
• Foster strong collaborations with internal stakeholders and external partners through two-way communication to build trusting relationships.
• Apply an understanding of new product development and commercialization to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates; use conventional and novel technologies through collaboration with cross-functional project teams and external vendors.

Education Minimum Requirements

• PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 3 years of pharmaceutical industry experience.
• Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience.
• Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience.

Required Experience And Skills

• Strong team player with excellent written and verbal communication skills, plus leadership and interpersonal abilities.
• Technical expertise and strategic experience in analytical control strategy development and execution.
• Ability to develop talent through mentoring.
• Demonstrated initiative, creativity, and problem-solving capabilities.
• Ability to design, execute and/or direct development and qualification of release, characterization, and stability assays for testing of clinical trial material and support of product and process development.
• Strong technical problem-solving abilities.
• External scientific engagement demonstrated by publications and presentations.
• Ability to work independently for method development and cross-functionally for successful transfer of methods; plan optimization and documentation to meet program deadlines.
• Authoring and reviewing internal technical reports, regulatory filing sections (e.g., IND, BLA) and external publications.
• Experience with matrix management and peer-to-peer coaching.
• Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

• Hands-on chromatography method development, analysis and troubleshooting (LC, GC).
• Mas…