Director of Pharmaceutical Manufacturing Science & Technology
On-siteMiddletown, Delaware, United States
Job Summary
Manage new product introduction, co-line evaluation, and technology transfer for clinical and PPQ projects from R&D to production. Lead cleaning verification and validation processes, including protocol drafting, sampling, and annual reviews. Provide technical support for routine production, investigate deviations, and draft continuous process verification and annual product quality review reports. Organize customer and official audits, respond to regulatory inquiries, and monitor FDA, EMA, and ISO guidelines to update internal processes. Requires a BS/MS in pharmacy or chemistry with 10+ years in pharmaceutical production technology. 20% domestic and international travel is required.
Required Qualifications
- BS/MS in Pharmacy or chemistry-related major
- familiar with pharmaceutical production, including manufacturing and cleaning processes
- proficient in lean production management methods
- 10+ years relevant work experience in the field of pharmaceutical production technology
- Strong hands-on leadership style
- Proficient in oral & written communication skills
- Demonstrated ability to read, write, and speak English
- Proficiency in Microsoft Office (Excel, Word, Outlook)
- Possesses basic knowledge of statistics and understands its practical application methods in the field of pharmaceutical production
- 20% travel is required: both domestic and international
- Strong knowledge of regulatory requirements (FDA, EMA, ISO)
- Excellent problem-solving and critical-thinking skills
- Strong leadership, communication, and project management skills
Desired Qualifications
- advanced degree
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