Manager- Product Development

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 innovative 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.