R And D softgel formulation

Department:

Research & Development (R&D) Softgel Formulation

Job Summary:

A reputed softgel manufacturer in Gujarat is seeking an accomplished R&D professional with 8-10 years of experience in softgel formulation and drug development. The ideal candidate will demonstrate expertise in pharmaceutical or nutraceutical softgel product development, process optimization, technology transfer, and the creation of QA/QC documents from scratch. Willingness to relocate to Gujarat is essential.

Key Responsibilities:

Softgel Formulation Development:

Lead the complete development process for softgel products, including excipient compatibility, fill and shell formulation for pharmaceuticals and nutraceuticals.

Process Scale-up & Optimization:

Design, execute, and optimize laboratory and pilot scale batches using rotary die or relevant softgel encapsulation technologies.

Product Development (NCE & Generics):

Drive projects involving both new chemical entities and generic softgel drugs, ensuring robust formulation and regulatory compliance.

QA & QC Documentation:

Independently develop and implement all necessary Standard Operating Procedures (SOPs), batch manufacturing and packing records, product specifications, method validation documents, and stability protocols.

Technology Transfer:

Prepare required documentation and ensure smooth transfer of technology and processes to manufacturing, QA, QC, and regulatory teams.

Cross-Functional Collaboration:

Coordinate with Quality Assurance, Quality Control, Regulatory, Procurement, and Production teams for successful project execution.

Regulatory & Compliance:

Support global regulatory filings, address queries, and maintain compliance with cGMP, ICH, and international regulatory standards.

Continuous Improvement:

Keep abreast of industry trends and proactively recommend improvements in formulation and manufacturing processes.

Qualifications & Requirements:

Educational Qualification:

M.Pharm in Pharmaceutics, Pharmaceutical Sciences, or a related discipline.

8-10 years of hands-on experience in softgel formulation and product development within the pharmaceutical or nutraceutical industry.

Strong technical expertise in softgel encapsulation, fill/shell composition, and process troubleshooting.

Proven ability to create all QA and QC documentation from the ground up.

Solid knowledge of cGMP, ICH, FDA, and other global regulatory requirements.

Experience in analytical method development and stability studies is an advantage.

Excellent teamwork, communication, problem-solving, and documentation skills.