Plan, direct, and oversee activities related to drug substance process development
Oversee and advise on scale-up activities from lab to plant and scale-down activities from plant to lab
Evaluate, select, and actively manage external parties (CROs, CMOs)
Collaborate with Quality to ensure compliance with GMP regulations
Manage priorities and timelines while optimizing processes incorporating Quality by Design (QbD) principles
Prepare drug substance development and manufacturing timelines, and set clear outcomes for projects
Prepare and review regulatory filings (including INDs, IMPDs, NDAs)
Author/review technical reports, SOPs, and policies with the Pharmaceutical Development team
Mentor direct reports and team members including providing feedback and coaching

Advanced degree (PhD/Masters) in chemical engineering or a related discipline
Minimum of 10 years of experience in the pharmaceutical or related industry
8 years in a supervisory role
Hands-on working experience and in-depth understanding of GMP and CMC regulatory requirements for small molecule drug substance manufacturing
Technical project leadership experience in drug substance process development
Expertise in QBD principles and risk assessments (FMEA, HAZOP)
Excellent interpersonal and communication skills (written and oral)
Experience leading and overseeing drug substance development programs
Demonstrated track record for developing and mentoring direct reports or junior team members

discretionary annual target bonus
stock options
ESPP
401k match
top-notch health insurance plans (medical, dental, vision, and basic life insurance)
20 days of PTO
10 paid holidays
winter company shutdown

Director, Pharmaceutical Technologies – Manufacturing

Key skills