Associate Director, Analytical Development (Biopharma)

TL;DR

Associate Director, Analytical Development (Biopharma): Providing scientific and strategic leadership for analytical method development and lifecycle management of oligonucleotide-based therapeutics with an accent on regulatory compliance and technical excellence. Focus on defining analytical control strategies, overseeing CRO/CDMO partners, and authoring regulatory submissions for clinical and commercial development.

Location: Full-time, in-person presence required in Bridgewater, NJ

Salary: $155,000–$201,500 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Lead analytical development, characterization, qualification, validation, and lifecycle management of methods for oligonucleotide therapeutics.
• Define and implement analytical control strategies, specifications, stability programs, and impurity characterization.
• Provide scientific oversight of analytical activities performed internally and at external CRO/CDMO partners.
• Author and review analytical sections of regulatory submissions, including INDs, CTAs, BLAs, and NDAs.
• Build, mentor, and develop scientific talent while fostering a culture of innovation and continuous learning.
• Define long-term analytical development strategy to support future oligonucleotide programs.

Requirements

• BS/MS degree with 6+ years of biopharmaceutical industry experience OR PhD with 2 years of experience.
• 3+ years of experience managing direct reports, including training and mentoring technical staff.
• Strong expertise in chromatographic techniques (IP-RP-UPLC, AEX, HILIC) and mass spectrometry-based characterization.
• Deep understanding of oligonucleotide impurity profiling, stability assessment, and specification setting.

Nice to have

• Degree in Chemistry, Biochemistry, or a related discipline.
• Working knowledge of FDA, EMA, ICH, and GMP global regulatory requirements for oligonucleotide products.
• Experience supporting regulatory submissions and health authority interactions.
• Proven ability to manage external CRO/CDMO relationships and analytical outsourcing.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage, including mental health support and wellbeing reimbursement.
• 401(k) plan with competitive company match, annual equity awards, and Employee Stock Purchase Plan (ESPP).
• Generous paid time off policies and fertility/family-forming benefits.
• Access to Company Learning Institute featuring LinkedIn Learning, leadership programs, and mentorship.
• Employee resource groups and opportunities for volunteering and community connection.