Manager- Product Development

Sentiss Pharma; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sentiss Pharma in India seeks a senior formulation development leader to drive ophthalmic and inhalation suspension projects, including technology transfer to manufacturing sites.

You will support regulatory dossiers for USFDA and European markets, contribute to 505(b)(2) submissions, and lead cross-functional teams to scale up, validate processes, and ensure GMP/GLP compliance. This role emphasizes innovation and mentorship.

Qualifications

• Proven experience in leading development of ophthalmic/inhalation suspensions and emulsions with successful tech transfers to CMOs.
• Hands-on experience handling regulatory queries for suspension products for USFDA and European markets.
• Experience in 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.

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 products being moved between locations
• Support to regulatory department in dossier filing
• GMP/GLP compliance of product development department
• Train and upgrade soft skills of formulators in product development
• Literature search for IGF upon request
• Review DMF from suppliers
• Prepare product feasibility based on IGF
• Create item codes for material and procure RLD
• Assist AD lab for Q1/Q2 estimation of RLD
• Draft tentative specifications for API, RM, finished goods
• Plan laboratory trials and stability batches
• Finalize proposed manufacturing process
• Initiate filter validation with filter supplier
• Handle Bead mill and high pressure homogenizer
• Identify training needs and provide training
• Identify equipment needs for product development department

Skills

Ophthalmic formulation development

Regulatory liaison (US/EU)

505(b)(2) submissions

Scale-up & process validation

Cross-functional leadership

GMP/GLP compliance

Training & mentoring

Job description

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 Ophthalamic/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 of505(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.