Senior Scientist (Analytical Development)

TL;DR

Senior Scientist (Analytical Development): Lead analytical development efforts for small-molecule drug substances and drug products supporting early- to late-stage programs with an accent on robust characterization, method development, and regulatory compliance. Focus on designing phase-appropriate quality control strategies, overseeing method transfers and external providers, and authoring analytical sections for regulatory submissions.

Location: Bridgewater, NJ office, full-time in-person presence required

Salary: $127,000–$165,500 annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Develop understanding of drug substance lifecycle including RSMs, intermediates, and APIs, ensuring quality and regulatory compliance
• Collaborate with process chemistry, QA, and regulatory teams on synthetic routes, impurity control, and analytical needs
• Oversee method development, validation, transfer, and GMP testing for internal and external partners
• Lead CMC programs as Analytical Lead, managing deliverables and timelines
• Author and review technical documents, SOPs, protocols, reports, and regulatory submissions (IND, IMPD, NDA/MAA)
• Design quality control strategies, specifications, and stability programs

Requirements

• Master’s degree + 5 years or Bachelor’s + 7 years in analytical development
• Strong background in pharmaceutical analytical chemistry and drug substance development
• Expertise in regulatory compliance (ICH, FDA, EMA), GMP, data integrity, and pharmaceutical lifecycle
• Experience leading cross-functional teams, managing timelines, and stakeholder communication
• Proficiency in analytical techniques: HPLC, GC, LC-MS, NMR, UV, FTIR
• Technical troubleshooting, data interpretation, method validation, CoAs, stability reports

Culture & Benefits

• Comprehensive medical, dental, vision, mental health support, EAP, wellbeing reimbursement
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules
• 401(k) with match, equity awards, ESPP, company-paid life/disability insurance
• Learning Institute: LinkedIn Learning, workshops, leadership programs, mentorship
• Employee resource groups, recognition programs, volunteering opportunities