Formulation R&D

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd. Hyderabad is seeking a formulation scientist to design and scale up oral solid dosage formulations, including tablets, capsules, and granules.

The role involves selecting excipients and processing techniques, developing QTPP-driven strategies, and ensuring compliance with cGMP during batch execution. Collaboration with QA and analytical teams will be essential to achieve robust, scalable products.

Qualifications

• Experience in developing oral solid dosage formulations.
• Proficient in design space and QbD for robust formulations.
• Knowledge of ICH guidelines and cGMP.

Responsibilities

• Design and develop robust formulations for OSDs (tablets, capsules, granules).
• Select excipients, processing methods, and equipment.
• Meet QTPP targets including bioavailability, stability and manufacturability.
• Perform pre-formulation studies on solubility, hygroscopicity, flow and compressibility.
• Plan, execute and supervise lab/pilot batches; ensure cGMP compliance.

Skills

Formulation development for OSDs

QbD & QTPP

cGMP compliance

Process optimization (DoE)

Analytical methods (DSC, FTIR)

Tools

DSC

FTIR

Granulation equipment

Tablet coating

Job description

• Design and develop robust, scalable formulations for oral solid dosage forms (OSDs) including tablets, capsules, and granules.
• Select appropriate excipients, processing techniques (e.g., direct compression, wet/dry granulation), and equipment.
• Develop formulations that meet target product profiles (QTPP), including bioavailability, stability, and manufacturability.

2. Pre-formulation & Compatibility Studies

• Conduct pre-formulation studies to evaluate properties such as solubility, hygroscopicity, flow, and compressibility.
• Perform drug–excipient compatibility studies using thermal and analytical methods (e.g., DSC, FTIR).

3. Experimental Batch Execution

• Plan, execute, and supervise laboratory-scale, exhibit, and pilot batches.
• Operate and troubleshoot equipment like blenders, granulators, tablet compression machines, capsule fillers, and coating pans.
• Ensure compliance with cGMP during batch execution.

4. Process Development & Optimization

• Optimize manufacturing processes using tools such as QbD and DoE.
• Establish process parameters and critical process attributes (CPAs, CPPs).
• Evaluate scalability and reproducibility for commercial manufacturing.

5. Stability Studies

• Design and initiate stability studies as per ICH guidelines.
• Coordinate with the analytical department for timely sample analysis and review of results.
• Monitor product behavior under different storage conditions and recommend formulation/process changes if needed.