Sudhakar Nakka

To build a challenging career in Analytical Research and Development within a progressive organization that fosters continuous learning and enables me to apply and enhance my knowledge, skills, and expertise through dedication and hard work.

Senior Lead Scientist - Syngene International Limited

(2023-03)

• Lead analytical development activities including method development, validation, and transfer for various dosage forms (solid orals, injectables, and topicals).
• Executing method development, particularly for chiral molecules.
• Oversee stability studies, data review, and trend analysis to support product shelf-life determination.
• Drive investigations for OOS, OOE, and OOT, ensuring robust root cause analysis and regulatory compliance.
• Manage analytical method transfers to manufacturing sites and ensure successful execution.
• Ensure adherence to cGMP and ALCOA+ principles in all analytical documentation.

Assistant Manager - Caplin Point Laboratories Ltd.

(2022-06 - 2023-03)

• Developed and validated analytical methods (HPLC, dissolution, assay, related substances) in line with ICH and USP guidelines.
• Conducted forced degradation studies and established stability-indicating methods.
• Reviewed analytical data and prepared validation protocols and reports.
• Supported regulatory submissions through accurate documentation and data integrity compliance.

Research Associate – IV - Aurobindo Pharma Pvt. Ltd.

(2019-09 - 2022-06)

• Performed routine analysis and stability studies for topical formulations.
• Investigated analytical deviations (OOS/OOT/OOE) with scientific justification and impact assessment.
• Contributed to method validation and preparation of analytical reports.

Research Associate - Aleor Dermaceuticals Ltd.

(2017-03 - 2019-09)

• Conducted analytical method development for topical and solid oral dosage forms.
• Performed pre-formulation and stability studies for R&D batches.
• Carried out instrument calibration and maintained compliance with laboratory standards.
• Documented analytical results in accordance with cGMP and data integrity requirements.

Master of Pharmacy - M.Pharm - Scient College of Pharmacy, JNTU, Hyderabad (2014 - 2016)

Bachelor of Pharmacy - M.Pharm - Malla Reddy College of Pharmacy, Osmania University, Hyderabad (2008 - 2012)