Key Responsibilities:
- Serve as the product subject matter expert throughout the commercial manufacturing lifecycle.
- Monitor process performance through data trending, statistical analysis, and ongoing product oversight.
- Lead technical investigations and drive effective corrective and preventive actions for process-related issues.
- Maintain product-specific quality risk assessments and support robust process control strategies.
- Ensure products remain in a continued state of validation through ongoing process verification activities.
- Partner with cross-functional teams to deliver process improvements, optimization initiatives, and manufacturing excellence projects.
- Support regulatory readiness, product transfers, and technical change implementation for assigned products.
Essential Requirements:
- Bachelorβs degree in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific degree.
- Minimum five years of experience in Oral Solid Dosage pharmaceutical manufacturing environments.
- Strong understanding of pharmaceutical manufacturing processes, regulatory requirements, and GMPs.
- Experience using data trending, statistical analysis, and process monitoring to drive decision-making.
- Proven ability to investigate process issues, identify root causes, and implement effective corrective actions.
- Demonstrated experience working collaboratively across technical, quality, and manufacturing functions.
Desirable Requirements:
- Master of Science degree in Pharmacy, Pharmaceutical Technology, Chemistry, or related field.
- Experience supporting product transfers, process optimization initiatives, and manufacturing excellence programs.
Benefits (as stated):
- Performance-based cash incentive; potential eligibility for annual equity awards.
- Comprehensive benefits package (health, life and disability, 401(k) with company contribution and match) and generous time off (vacation, personal days, holidays, other leaves).