Key Responsibilities Scientific & Technical Leadership • Lead analytical support for excipient innovation, formulation development, technical service, and lifecycle management.

• Oversee method development, validation, transfer, troubleshooting, and stability studies for drug product and excipients.

• Support excipient characterization, compatibility studies and novel drug delivery technologies.

• Review and approve protocols, reports, specifications, and technical assessments.

• Lead OOS/OOT investigations, root-cause analysis, risk assessments, and CAPA activities.

• Drive adoption of advanced analytical technologies, automation, and digital laboratory tools.

• Support regulatory submissions, customer audits, due diligence reviews, and technical discussions.

Project & Portfolio Management • Manage analytical deliverables across R&D; and customer projects.

• Collaborate with formulation, quality, regulatory, marketing, business development, and global teams.

• Monitor timelines, resources, budgets, and project risks.

• Support technology platforms including tablets, capsules, softgels, gummies, chewables, and emerging dosage forms.

• Drive laboratory productivity, efficiency, and data quality improvements. Customer & Technical Support • Provide analytical expertise for customer formulation and troubleshooting projects.

• Support technical presentations, publications, application guides, and marketing materials.

• Contribute to innovation initiatives and new business opportunities.

People

Leadership • Lead, mentor, and develop a high-performing analytical team.





• Build a culture of scientific excellence, accountability, collaboration, and innovation.

• Drive talent development, succession planning, and capability building.

• Promote knowledge sharing, employee engagement, and laboratory safety.Quality & Operational Excellence • Ensure compliance with GMP, GLP, Data Integrity, and corporate quality standards.

• Maintain audit and inspection readiness.

• Drive EHS compliance and secure laboratory operations.

• Oversee laboratory infrastructure, instrument qualification, calibration, and maintenance and new capex.

Technical Requirements Core Expertise • Analytical development and characterization of pharmaceutical excipients and drug products.

• Method development, validation, transfer, and lifecycle management.

• Stability studies and degradation investigations.

• Excipient characterization and compatibility assessments.

• Impurity profiling, root-cause analysis, and problem solving.

Analytical Techniques

Hands-on knowledge of:

• HPLC / UHPLC • GC / Headspace GC • UV-Visible Spectroscopy • FTIR • Dissolution Testing • Karl Fischer Titration • Particle Size Analysis • Rheology & Viscosity Measurements • DSC, TGA & Thermal Analysis • Solid-State Characterization • LC-MS / GC-MS (preferred) Regulatory & Quality KnowledgICH guidelines and global regulatory requirements.

• USP, EP, BP, and JP standards.

• Pharmaceutical excipient regulations and quality systems.

• Regulatory submissions and customer documentation packages.

• GMP, GLP, and Data Integrity requirements.

📌 Analytical Lead – Analytical Development & Laboratory Operations (Bengaluru)
🏢 SPI Specialties Pharma
📍 Bengaluru