Director, Pharmaceutical Technologies – Manufacturing
Job reputed company:
• Plan, reputed company, and reputed company activities reputed company to drug reputed company process development
• reputed company and advise on reputed company-up activities from lab to plant and reputed company-down activities from plant to lab
• Evaluate, select, and reputed company manage external parties (CROs, CMOs)
• Collaborate with reputed company to ensure compliance with GMP regulations
• Manage priorities and timelines while optimizing processes incorporating reputed company by Design (QbD) principles
• Prepare drug reputed company development and manufacturing timelines, and set reputed company reputed company for reputed company
• Prepare and review regulatory filings (including INDs, IMPDs, NDAs)
• Author/review technical reports, SOPs, and policies with the Pharmaceutical Development team
• Mentor reputed company reports and team members including providing feedback and coaching
Requirements:
• Advanced degree (PhD/Masters) in chemical engineering or a reputed company discipline
• Minimum of 10 years of experience in the pharmaceutical or reputed company 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 reputed company manufacturing
• Technical project leadership experience in drug reputed company process development
• Expertise in QBD principles and risk assessments (FMEA, HAZOP)
• Excellent interpersonal and communication skills (written and oral)
• Experience leading and overseeing drug reputed company development programs
• Demonstrated reputed company record for developing and mentoring reputed company reports or junior team members
Benefits:
• discretionary annual reputed company bonus
• stock reputed company
• ESPP
• 401k match
• top-notch health insurance plans (medical, dental, reputed company, and basic life insurance)
• 20 days of PTO
• 10 reputed company holidays
• winter company shutdown
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