Senior Director, Large Molecule, Analytical Development & QC (Biopharma)

TL;DR

Senior Director, Large Molecule, Analytical Development & QC (Biopharma): Shaping and executing analytical framework for large molecules from early development to commercialization with an accent on method development, validation, characterization, and stability testing. Focus on ensuring regulatory compliance (ICH, FDA, EMA), managing internal/external labs, and leading cross-functional collaborations.

Location: Based out of Bridgewater HQ or NJ RDL Lab with full-time, in-person presence required to support hands-on collaboration and operational needs.

Salary: $214,000–$292,000 Annual

Company

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

What you will do

• Build and lead multidisciplinary Analytical Development and QC teams.
• Oversee analytical activities at contract laboratories and establish comprehensive approaches for large-molecule programs including characterization, method development, validation, release, and stability testing.
• Align analytical strategies with CMC development stages and regulatory standards, providing technical leadership to stakeholders.
• Partner with Process Development, Manufacturing, Quality Assurance, and Regulatory functions to meet program objectives.
• Support regulatory inspections, manage out-of-specification investigations, deviations, root cause analyses, and CAPA development.
• Lead build-out of new analytical laboratory from concept to operational readiness including qualification and lifecycle management.

Requirements

• B.S./M.S. in Chemistry, Biochemistry or related with 15+ years experience or PhD with 5+ years in biopharmaceutical industry.
• 5+ years leadership experience with training and mentoring technical staff.
• Hands-on experience with analytical techniques: chromatography (HPLC, UPLC, SEC, GC), mass spectrometry (LC-MS, GC-MS); Waters/Empower preferred, SEC-MALS/MS advantageous.
• Strong statistical skills and proven track record with biologics regulations (FDA, EMA, ICH).
• Excellent presentation, communication, and cross-functional collaboration skills.
• Proficient in Microsoft Office, Veeva, Trackwise; highly organized with analytical thinking.

Culture & Benefits

• Comprehensive medical, dental, vision, mental health support, wellbeing reimbursement, and Employee Assistance Program.
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules with in-person collaboration.
• 401(k) with company match, equity awards, ESPP, company-paid life/disability insurance.
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship, and networking.
• Employee resource groups, recognition programs, volunteering opportunities.
• Frequent travel up to 30% for vendor relationships.