Job Description
- 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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