Key Responsibilities:

- Product development for US, Russia & Europe market

- Improvement of current products for Russian market.

- Development of Herbal products for Indian & Russian market.

- Technology transfer of new products to manufacturing locations.

- Technology transfer support for the products to be transferred from one location to other location.

- To provide support to regulatory department in dossier filing.

- Para IV possibilities for ophthalmic products.

- GMP/GLP compliance of product development department.

- To conduct training and upgrade soft skills of formulators in product development.

- To perform literature search required for idea generation form (IGF) upon receiving IGF.

- To review DMF received from suppliers.

- To prepare product feasibility based on IGF received.

- To create the item codes for material and procure material and Reference Listed Drug (RLD).

- To assist AD lab for Q1 Q2 estimation of RLD.

- To draft tentative specification for API, RM and finished good.

- To plan laboratory trials and stability batches.

- To finalize proposed manufacturing process.

- To initiate filter validation process with the filter supplier.

- To handle Bead mill and high pressure homogenize
- To identify training needs of subordinates and provide training to them.

- To identify needs for product development department in terms of equipment and procure them.

Documentation:-

- To prepare tech transfer documents including MFR, BOM, Process flowchart,



Critical process parameters and critical quality activities.

- To review product specifications, manufacturing documents.

- To prepare documents for trial batches.

- To prepare product development report.

- To prepare and review SOPs and prepare response for internal audits.

- To review documents related to filter validation.

Product Specification/ Tech Transfer/ Commercialization

- To organize and execute trial pre exhibit and exhibit batches at plant.

- To execute first three commercial batches at plant.

- To provide technical support for existing commercial batch.

- To perform investigation of failures during exhibit batches/ stability (Out of Specification).

Innovation

- To come up with creative and patentable formulations proposals.

- To come up with novel ideas which can reduce workload or expenses.

Key Competencies

- Proven experience in leading the development of Ophththalmic/Inhalation suspension and emulsion formulations, including successful technology transfer to manufacturing sites/CMOs.

- Hands-on experience in handling regulatory queries for suspension products for USFDA and European markets, with active involvement in product approvals.

- Experience in the development and submission of 505(b)(2) products.

- Strong understanding of scale-up, process optimization, and validation for sterile liquid formulations.

- Ability to lead cross-functional teams (PD, AD, QA, RA, Manufacturing) for timely project execution.

📌 Manager- Product Development (Gurugram)
🏢 Sentiss Pharma
📍 Gurugram