Senior Manager, R & D Formulation

Strong expertise in pharmaceutical formulation development, optimization, and product improvement.

Thorough understanding of pre-formulation studies, excipient selection, dissolution testing, stability assessment, and dosage-form design.

Knowledge of GMP standards, ICH guidelines, applicable pharmacopeial standards, and relevant regulatory requirements.

Excellent analytical thinking, scientific decision-making, technical troubleshooting, and problem-solving skills.

Lead the Formulation R&D team in developing new pharmaceutical products, generic formulations, product line extensions, and improved formulations aligned with business objectives.

Plan and oversee formulation development across various dosage forms, including tablets, capsules, oral liquids, suspensions, topical preparations, and other pharmaceutical products.

Assess and select appropriate APIs, excipients, and packaging materials based on compatibility, quality, functionality, availability, and cost.

Conduct pre-formulation research, formulation trials, prototype development, and optimization to achieve the required product quality, efficacy, and stability.

Oversee laboratory-scale development, pilot studies, process optimization, scale-up, and technology transfer to Production for commercial manufacturing.

Coordinate stability studies with QC and Stability teams to determine product shelf life, storage conditions, and regulatory compliance.

Collaborate with Analytical R&D, QC, QA, Regulatory Affairs, Production, and other departments to support product development, registration, and commercialization.

Analyze formulation data, analytical findings, dissolution profiles, compatibility results, and stability studies to resolve technical and manufacturing challenges.

Prepare, review, and maintain accurate formulation reports, study protocols, batch manufacturing records, specifications, SOPs, and regulatory submission documents.

Ensure adherence to GMP standards, relevant regulatory guidelines, data integrity principles, and internal quality systems throughout development activities.

Set project priorities, schedules, resource plans, and budgets while managing laboratory equipment, raw materials, and consumables efficiently.

Mentor and develop R&D team members while identifying opportunities for portfolio expansion, product lifecycle management, reformulation, cost reduction, and continuous improvement.