Senior Director, Small Molecule (Biopharma)

TL;DR

Senior Director, Small Molecule (Analytical Development): Provide strategic and operational leadership for analytical activities developing, validating, and implementing strategies for small molecule programs from early development to commercialization with an accent on method development, stability, characterization, and regulatory compliance. Focus on aligning analytical and QC strategies with CMC objectives, managing internal/external labs, and building high-performing teams.

Location: Hybrid role based out of Bridgewater, NJ office with option to work remotely most of the time and in-person collaboration when needed. Frequent travel up to 30% for vendor relationships.

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

• Oversee analytical activities at contract laboratories, manage CDMOs and external labs to meet timelines and quality standards
• Develop and implement analytical strategies for small molecule APIs and drug products across development phases
• Align analytical approaches with CMC stages and regulatory standards, provide technical leadership to stakeholders
• Partner with process development, manufacturing, QA, and regulatory to meet program objectives
• Support regulatory inspections, handle OOS/non-conformance investigations, and contribute to CMC team as SME
• Lead build-out of new analytical laboratory and drive continuous improvement for data integrity and efficiency

Requirements

• B.S./M.S. in Chemistry, Biochemistry or related with 15+ years experience or PhD with 5+ years in biopharma
• 5+ years managing direct reports with training/mentoring experience
• Demonstrated Director/Senior Director leadership in GMP environment
• Hands-on experience with chromatography (HPLC, UPLC, SEC, GC), mass spec (LC-MS, GC-MS); Waters/Empower preferred
• Strong statistical skills, regulatory knowledge (FDA, EMA, ICH)
• Excellent communication, cross-functional collaboration, Microsoft Office, Veeva, Trackwise proficiency

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 with LinkedIn Learning, workshops, leadership programs, mentorship
• Employee resource groups, recognition programs, volunteering opportunities