Senior Director, Small Molecule Drug Product Manufacturing
$200,500–$270,500 year
On-siteHopewell, Virginia, United States
Job Summary
Lead overall leadership and regulatory compliance for the Small Molecule Drug Product Manufacturing facility, managing Safety, Quality, Delivery, Cost, and People across dispensing, granulation, blending, compression, coating, encapsulation, packaging, warehousing, and support functions. Influence manufacturing strategy and network planning while partnering with cross functions to support product launches and long-term capacity needs. Represent manufacturing in executive governance meetings and ensure state of inspection readiness for FDA, EMA, and global regulatory expectations. Drive operational excellence through Lean Manufacturing, Six Sigma, and continuous improvement programs, managing the operating budget and financial performance. Lead facility startup, expansion, technology transfer, and commercialization initiatives, overseeing oral solid dosage operations including tablet compression, encapsulation, film coating, and packaging. Build and develop a high-performing manufacturing organization, fostering collaboration across Manufacturing, Quality, Supply Chain, Engineering, Validation, Technical Services, and EHS.
Required Qualifications
- 10+ years of managerial experience directly managing people
- Direct leadership of Manufacturing Managers, Production Supervisors, and Operations Leaders
- Indirect leadership of production technicians, operators, warehouse personnel, and support functions
- Member of Site Leadership Team
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline
- 12+ years of pharmaceutical manufacturing experience
- 10+ years of progressive leadership experience in GMP pharmaceutical operations
- Demonstrated success managing commercial small molecule drug product manufacturing facilities
- Experience supporting FDA, EMA, MHRA, PMDA, and other regulatory inspections
- Proven leadership of facility startup, expansion, technology transfer, or commercialization activities
- Demonstrated success driving operational excellence and productivity improvements
- Oral Solid Dosage (OSD) manufacturing
- Granulation technologies
- Compression and encapsulation operations
- Film coating processes
- Packaging and serialization systems
- Process validation and continued process verification
- Quality systems (Deviations, CAPA, Change Control)
- Supply Chain and S&OP processes
- FDA 21 CFR Parts 210/211 EU GMP requirements
- Data integrity requirements
- Lean Manufacturing and Six Sigma methodologies
- Strong PC literacy
- MS Office skills (Outlook, Word, Excel, PowerPoint)
- Travel: Up to 20%
Desired Qualifications
- Master's degree
- 8+ years of experience
- MBA
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