Serve as a senior technical resource for pharmaceutical products from early development through scale-up, transfer, launch, and ongoing commercial operations.
Provide scientific and technical expertise for solid oral dosage forms, including formulation and process optimization, manufacturing support, and product lifecycle activities.
Develop and execute technical studies involving manufacturing processes, equipment, raw materials, process performance, and scale-up activities.
Contribute to regulatory submissions by preparing and reviewing technical content, scientific rationales, regulatory responses, and applicable eCTD documentation.
Ensure technical reports and regulatory materials are scientifically sound, accurate, well-supported by data, and aligned with GMP requirements.
Facilitate technical discussions, present study results and recommendations, and communicate complex scientific information to both technical and non-technical stakeholders.
Identify opportunities to improve process capability, manufacturing efficiency, product quality, and overall operational performance.
Develop and deliver technical training to manufacturing teams when introducing new processes, procedures, or process improvements.
Qualifications
Bachelor's degree or higher in Pharmaceutical Sciences, Pharmaceutics, Chemistry, Chemical Engineering, Biology, or another relevant scientific or engineering discipline.
Minimum of 15 years of pharmaceutical industry experience, preferably in a senior individual contributor or technical expert role.
Extensive experience working with solid oral dosage pharmaceutical products.
Demonstrated background spanning pharmaceutical development/process development as well as commercial manufacturing support.
Strong knowledge of process development, scale-up, technology transfer, process characterization, optimization, and product lifecycle management.
Proven ability to prepare, review, and interpret complex technical, scientific, and GMP-regulated documentation.
Experience supporting eCTD content, regulatory submissions, technical assessments, and responses to regulatory inquiries.
Familiarity with electronic quality, manufacturing, and documentation systems such as MasterControl, SAP, or similar platforms is preferred.
