Senior Scientist / Manager Formulation R&D

Senior Scientist / Manager – Formulation R&D

Department: Research & Development

Function: Formulation R&D

Reporting to: HOD – Formulation R&D & QA

Location: ENTOD Pharmaceuticals, Mumbai / R&D Facility

Role Purpose

ENTOD Pharmaceuticals is looking for a highly motivated and scientifically driven Senior Scientist / Manager – Formulation R&D to strengthen its formulation development team.

The individual will work directly with the HOD – Formulation R&D & QA and take ownership of formulation-development projects from concept and feasibility through optimisation, stability, scale-up and technology transfer.

A key component of the position will be to identify, develop and protect intellectual property arising from ENTOD's R&D activities, including formulation patents, process innovations and other potentially patentable technologies.

Key Responsibilities

Formulation Development

* Independently plan, design and execute formulation-development projects.

* Develop and optimise ophthalmic and other specialty pharmaceutical formulations.

* Work on conventional as well as complex dosage forms including solutions, suspensions, emulsions and novel drug-delivery systems.

* Undertake pre-formulation studies including solubility, pH, osmolality, excipient compatibility and physicochemical characterisation.

* Apply principles of QbD, DoE and risk-based pharmaceutical development wherever appropriate.

* Troubleshoot challenges involving solubility, stability, precipitation, degradation, preservative compatibility and drug–excipient interactions.

Project Ownership

* Take responsibility for assigned projects from laboratory concept to development-ready formulation.

* Prepare development plans, experimental protocols and project timelines.

* Monitor milestones and proactively identify technical risks and solutions.

* Coordinate with analytical development, microbiology, QA, regulatory, manufacturing and other functions.

* Support scale-up, exhibit/registration batches and technology transfer to manufacturing.

Ophthalmic & Sterile Product Development

* Contribute to the development of sterile ophthalmic formulations, including challenging and poorly soluble molecules.

* Understand critical ophthalmic parameters including ocular tolerability, pH, tonicity, viscosity, particle characteristics, preservative systems and container-closure considerations.

* Support formulation and development strategies relating to sterility and product stability.

Prior ophthalmic/sterile formulation experience would be strongly preferred.

Intellectual Property & Patents

* Identify patentable innovations arising from formulation development, drug-delivery technologies, manufacturing processes and other R&D activities.

* Conduct prior-art, scientific literature and patent landscape searches to assess novelty and differentiation.

* Work closely with the HOD, senior management and ENTOD's patent/IP attorneys to develop appropriate IP protection strategies.

* Prepare invention disclosures and provide scientific and technical inputs for drafting and filing patent applications.

* Coordinate with patent attorneys/IP consultants during patent drafting, filing, examination and prosecution.

* Provide technical responses and experimental evidence required to address patent-office examination reports and objections.

* Assist in designing experiments and generating data specifically required to strengthen patent claims and establish technical advantages.

* Monitor relevant competitor patents and emerging IP within ENTOD's areas of research.

* Help build and maintain a strong R&D intellectual-property pipeline and patent portfolio.

* Ensure potentially patentable inventions are appropriately protected before publication, presentation or external disclosure.

Scientific & Technical Leadership

* Act as a key technical support to the HOD – Formulation R&D & QA.

* Guide and mentor junior formulation scientists and research associates.

* Review experiments, results, development reports and laboratory documentation.

* Encourage scientific thinking, innovation and systematic problem-solving within the R&D team.

* Remain abreast of advances in formulation science, drug delivery, excipients and pharmaceutical technologies.

Documentation & Regulatory Support

* Maintain high-quality development documentation and laboratory records.

* Prepare formulation-development reports and technical summaries.

* Provide formulation inputs for regulatory dossiers and responses to regulatory queries.

* Ensure development activities are conducted in accordance with applicable quality systems and regulatory expectations.

Candidate Profile

Education: M.Pharm in Pharmaceutics / Pharmaceutical Technology or related discipline.

PhD in Pharmaceutics, Pharmaceutical Sciences, Drug Delivery or a related field would be highly desirable, particularly where combined with strong practical formulation-development experience.

Experience: Approximately 5–10 years of relevant formulation R&D experience, preferably including ophthalmic, sterile, complex or novel drug-delivery formulations.

Previous involvement in pharmaceutical patent drafting, invention disclosures, prior-art searches or successful patent filings would be a significant advantage.

What We Are Looking For

ENTOD is looking for someone who:

* Is fundamentally a scientist, innovator and problem-solver.

* Can independently take ownership of technically challenging formulation projects.

* Can recognise when an experimental result or formulation approach represents potentially valuable intellectual property.

* Understands both the scientific and practical aspects of converting an invention into a patent application.

* Can work effectively with patent attorneys and translate complex laboratory science into clear technical information for IP filings.

* Can guide younger scientists while remaining hands-on in development.

* Is curious about new molecules, drug-delivery technologies and formulation approaches.

* Wants to help translate scientific ideas into commercially viable and protectable pharmaceutical products.

The Opportunity

The successful candidate will work closely with ENTOD's R&D leadership on innovative ophthalmic and specialty pharmaceutical products, while playing an important role in strengthening both the company's formulation-development capabilities and intellectual-property portfolio.

The objective is not simply to develop another formulation — but to create differentiated pharmaceutical technologies, protect the innovation behind them, and ultimately translate them into better medicines.