Associate Principal Scientist, Analytical R&D

Overview

The Pharmaceutical Analytical Sciences (PAS) group is seeking an Associate Principal Scientist located in Rahway, NJ. The role focuses on developing innovative analytical methodologies for small molecules, peptides, oligonucleotides, and bioconjugates across the entire product lifecycle, from early development to commercialization. Responsibilities also include regulatory submissions to support clinical trials.

• Driving the Company’s Pipeline
  • Lead or participate on analytical teams developing drugs in the pipeline, understanding product development from early stage to commercialization.
  • 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, validation, and specification setting.
  • Author IND, IMPD, NDA/WMA submission documents across the development lifecycle and respond to agency questions.
• Scientific Excellence and Regulatory Influence
  • Promote scientific excellence and regulatory influence through leadership in the scientific community.
  • Advance analytical capabilities through adoption of novel technologies for product and process characterization.
  • Design and execute experiments that influence programs with data‑driven decisions.
• Leadership
  • Mentor and oversee junior analytical scientists.
  • Represent the team in presentations to governance committees and internal audiences.
  • Identify and elevate program risks proactively.
  • Foster collaborations with internal stakeholders and external partners via two‑way communication.

Education Minimum Requirements

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with ≥3 years pharmaceutical industry experience.
• Master’s in the same fields with ≥7 years experience.
• Bachelor’s with ≥10 years experience.

Required Experience and Skills

• Strong team player with excellent written and oral communication, leadership, and interpersonal skills.
• Expertise in analytical control strategy development and execution.
• Ability to mentor talent effectively.
• Initiative, creativity, and innovative problem‑solving.
• Design, execute, and direct development and qualification of release, characterization, and stability assays for clinical trial material and product/process development.
• Strong technical problem‑solving ability.
• External scientific engagement demonstrated by publications and presentations.
• Independent development of analytical methodologies and cross‑functional transfer of methods.
• Plan optimization and documentation to meet program deadlines.
• Authoring and reviewing technical reports, regulatory filings (e.g., IND, BLA) and external scientific publications.
• Matrix management and peer‑to‑peer coaching experience.
• Deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills

• Hands‑on chromatography (LC, GC) method development, analysis, and troubleshooting.
• Advanced analytical techniques such as mass spectrometry or dissolution.
• Development and characterization of small and/or large molecules, and/or antibody drug conjugates.
• Established scientific reputation via publications and external presentations.
• High‑throughput experimentation and data‑rich experimentation, or data science experience.

Required Skills

• Analytical Chemistry, Analytical Method Development, Assay Development, Bioanalysis, Biological Assay Development, Cell‑Based Assays, Chromatographic Techniques, Conducting Experiments, High Resolution Mass Spectrometry (HRMS), Immunochemistry, Liquid Chromatography‑Mass Spectrometry (LC‑MS), Mass Spectrometry Analysis, Messenger RNA, Pharmaceutical Sciences, Protein Analysis.

Preferred Skills

• Data science experience and related technical skills.

Salary range: $ – $ (base salary). Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, healthcare and other insurance benefits, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.

We are an Equal Employment Opportunity Employer and provide equal opportunities for all employees and applicants. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC website.