Job Description:

- 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 Ophthalmic/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.

Qualification - M.Pharma (Pharmaceutical)

Experience - Minimum 10years of relevant experience

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