Director, Pharmaceutical Technologies – Manufacturing

Job Description:
• 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

Requirements:
• 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

Benefits:
• 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

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