Principal Scientist, Technical Services

Daily Tasks

• Lead technical support for commercial solid oral dosage products, ensuring efficient manufacturing operations and continuous process improvements.
• Drive process development, scale-up activities, technology transfers, and process validation for new and existing products.
• Investigate manufacturing deviations and product quality concerns by performing root cause analyses and implementing effective corrective actions.
• Develop, review, and approve technical documentation, including validation protocols, reports, investigations, change controls, batch records, and regulatory submissions.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Validation, and R&D teams to resolve technical challenges and support product launches.
• Analyze manufacturing data and apply statistical tools to optimize processes, improve yields, and enhance product performance.
• Provide technical guidance and mentorship to junior scientists while serving as a subject matter expert for cross-functional project teams.
• Support regulatory inspections, internal audits, and compliance initiatives to maintain FDA and cGMP standards.
• Participate in project planning, prioritize multiple technical initiatives, and deliver results within established timelines.
• Provide occasional after-hours technical support for critical manufacturing activities when needed.

Qualifications/Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific discipline; advanced degree (MS or PhD) preferred.
• 15+ years of pharmaceutical manufacturing experience with a strong focus on solid oral dosage products.
• Demonstrated expertise in process development, technology transfer, process validation, and commercial manufacturing support.
• Strong knowledge of cGMP regulations, FDA guidelines, ICH requirements, and pharmaceutical quality systems.
• Experience leading complex manufacturing investigations, root cause analyses, and continuous improvement initiatives.