Role & responsibilities

Department: Formulation Analytical Development

Key Responsibilities

- Leads the scientific design of experiments and application of analytical strategies to understand drug product performance, stability, and manufacturability. Integrates data from multiple characterization techniques to solve formulation and process development challenges, establish mechanistic understanding, and support robust decision-making. Provides expert consultation to formulation scientists on study design, root-cause investigations, and interpretation of complex datasets. Drives technical excellence through innovation, knowledge sharing, and mentoring of junior staff.
- Review and interpret analytical data generated from assigned formulation and pre-formulation projects, ensuring data quality, scientific accuracy, and compliance with applicable procedures.
- Prepare, review, and execute protocols for stability studies, drug-excipient compatibility studies, and physical stability assessments in accordance with approved procedures and study plans.
- Support formulation and pre-formulation development activities through chromatographic and spectroscopic data analysis, interpretation, and reporting.
- Possess strong hands-on experience and expertise in operating, maintaining, troubleshooting, and interpreting data from analytical instruments, including:

1 PXRD 2 DSC

3 PSD

4 DVS

5 TGA

6 HPLC

7 Dissolution Apparatus

8 Disintegration Tester

- Perform instrument calibration, verification, and routine performance checks for analytical equipment such as PXRD, DSC, PSD, DVS, TGA, HPLC, analytical balances, and pH meters.
- Conduct analytical method development, method optimization, stability studies, and solubility assessments for formulation and pre-formulation projects.
- Ensure proper maintenance, operation, and compliance of laboratory instruments, equipment, facilities,



and supporting systems in line with Good Laboratory Practices (GLP) and internal procedures.
- Identify, troubleshoot, and resolve analytical and technical challenges related to formulation development. Investigate deviations, out-of-specification (OOS), and unexpected analytical results.
- Lead, mentor, and manage a team of analytical scientists/analysts by fostering a team-oriented, high-performance, and innovation-driven work environment.
- Provide technical training, coaching, and professional development opportunities to team members to enhance analytical and scientific competencies.
- Collaborate effectively with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and other project stakeholders.
- Monitor and coordinate qualification activities for new instruments and equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as well as calibration and preventive maintenance programs.
- Communicate project plans, progress, risks, challenges, and mitigation strategies to internal management, project teams, customers, and other stakeholders.
- Maintain accurate, complete, and compliant documentation in laboratory notebooks, electronic laboratory notebooks (ELN), study records, and technical reports in accordance with Good Documentation Practices (GDP).
- Drive continuous improvement initiatives through the adoption of new analytical technologies, scientific approaches, and operational best practices.




- Demonstrate sound knowledge of chemical safety, risk assessment, containment requirements, and safe handling of drug substances, active pharmaceutical ingredients (APIs), excipients, and chemicals.
- Adhere strictly to Health, Safety, and Environment (HSE) policies while performing experiments, handling materials, transferring samples, and working with active pharmaceutical compounds.
- Possess working knowledge of preventive maintenance requirements for laboratory instruments and equipment.
- Ensure safe handling and storage of new chemical entities (NCEs), APIs, excipients, solvents, reagents, and packaging materials in accordance with Material Safety Data Sheets (MSDS) and established safety procedures.
- Deliver assigned project objectives and departmental goals within agreed timelines while maintaining quality and compliance standards.
- Prepare, review, revise, and implement Standard Operating Procedures (SOPs), work instructions, protocols, reports, and related quality documents.
- Prepare, review, execute, and support qualification activities, including Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for laboratory instruments and equipment.

Key Competencies (Technical, Functional & Behavioural) Technical & Functional

- Demonstrated capability in having understanding to design and interpret data from PXRD, modulated DSC, TGA, DVS, Microscopy and working operations of HPLC, GC, FT-IR, NMR, Dissolution, BET and other physical and physicochemical characterization techniques. Hands-on operating would be an added plus.
- Excellent problem-solving and analytical skills.
- Strong written and verbal communication skills.

Qualification and Experience: M. Pharm. or M.S. Pharm in analytical chemistry or pharmaceutical analysis with 7-10 years of experience in formulation analytical development area (Oral solids)

📌 Pre Formulations - Associate Research Scientist - Shameerpet (Hyderabad)
🏢 Sai Life Sciences
📍 Hyderabad