This role is designed for experienced pharmaceutical professionals who bring deep expertise in formulation science, product development, and regulatory alignment, with the ability to translate complex scientific concepts into commercially viable products. As a Senior Manager – Formulation R&D, you will play a pivotal role in driving the development of high-quality, scalable, and compliant formulations across regulated markets.

You will lead the end-to-end lifecycle of formulation development, from pre-formulation studies and prototype design to optimization, validation, and successful technology transfer to manufacturing. The role demands a strong understanding of Quality by Design (QbD) principles, enabling data-driven decision-making and robust product development strategies.

Responsibilities

Lead end-to-end formulation development for oral solids / injectables / complex generics

Drive QbD-based development strategies and product optimization

Manage multiple R&D programs with defined timelines and delivery milestones

Collaborate with Analytical, Regulatory, and Manufacturing teams

Ensure readiness of documentation for ANDA / NDA filings

Handle regulatory queries and audits (USFDA, EMA, MHRA)

Lead technology transfer and scale-up to commercial manufacturing

Build and mentor high-performance R&D teams

What We’re Looking For

M.Pharm / Ph.D. in Pharmaceutics or related field

11+ years of experience in Formulation R&D (regulated markets)

Strong expertise in QbD, DoE, scale-up, and validation

Experience in complex generics / injectables / modified release formulations

Solid understanding of ICH guidelines and cGMP practices

Proven leadership and stakeholder management skills