Associate Principal Scientist, Analytical R&D
Listed on 2026-07-14
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Research/Development
Pharmaceutical Science/ Research, Biotech Research, Research Scientist, Regulatory Compliance Specialist
Job Description
Our Pharmaceutical Analytical Sciences (PAS) group invites an Associate Principal Scientist in Rahway, NJ to drive innovation in drug development and regulatory science. The role blends analytical leadership, strategic development, and cross‑functional collaboration across the product lifecycle.
Responsibilities- Lead or support analytical teams developing methods for small molecules, peptides, oligonucleotides, and bioconjugates from early discovery through commercialization.
- Partner with functional areas to design scientific studies that inform product and process development.
- Define and implement end‑to‑end analytical control strategies for clinical supplies, including method development, validation, and specification setting under GMP.
- Author regulatory documentation such as IND, IMPD, NDA/WMA submissions, and respond to agency questions throughout the development lifecycle.
- Promote scientific excellence and regulatory impact through participation in the scientific community and cross‑functional collaboration.
- Mentor and oversee junior analytical scientists, facilitating career development.
- Present technical information to governance committees and internal audiences, and actively manage program risks.
- Apply conventional and novel technologies to address analytical challenges across varied therapeutic modalities.
- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with ≥3 years of pharmaceutical industry experience.
- Master’s in same field with ≥7 years of industry experience.
- Bachelor’s in same field with ≥10 years of industry experience.
- Strong team‑building, communication, and leadership skills.
- Demonstrated ability to develop talent, manage complex objectives, and innovate solutions.
- Experience in analytical control strategy development, assay qualification, and regulatory filing.
- Published scientific work or active engagement in the scientific community.
- Hands‑on chromatography (LC, GC) method development and troubleshooting.
- Advanced analytical techniques such as mass spectrometry, dissolution, or high‑throughput experimentation.
- Experience with small or large molecule development, or antibody drug conjugates.
- Data‑rich experimentation or data‑science skills.
Salary range: $ – $. Compensation may also include annual bonus and long‑term incentive awards, depending on qualifications and location. We offer a comprehensive benefits package, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days.
Equal Opportunity EmploymentWe are an equal‑opportunity employer. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law. As a federal contractor, we also comply with affirmative action requirements for veterans and individuals with disabilities.
Job Posting End Date: 08/8/2026
Requisition : R405320
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