Manager - Product Development (Sterile/Ophthalmic)

Sentiss Pharma Pvt. Ltd.

Gurugram District

On-site

INR 2,500,000 - 4,500,000

Full time

14 days+

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Job summary

Sentiss Pharma Pvt. Ltd. in India seeks a Senior Pharmaceutical Scientist to lead ophthalmic/inhalation formulation development, scale-up, and technology transfer to manufacturing sites, including DMF reviews and regulatory liaison.

Candidates should have MP. Pharma and 10+ years experience; lead cross-functional teams (PD, AD, QA, RA, Manufacturing) and drive regulatory approvals (USFDA and European markets) for 505(b)(2) products with strong GMP/GLP understanding.

Qualifications

M.Pharma (Pharmaceutical) is required.
Proven leadership in ophthalmic/inhalation formulations development and technology transfer.
Experience with regulatory queries for USFDA and European markets.

Responsibilities

Lead development of ophthalmic/inhalation suspension and emulsion formulations.
Drive technology transfer to manufacturing sites/CMOs.
Prepare and review tech transfer documents (MFR, BOM, Process flowchart, CPs, CQAs).
Support regulatory dossier filing and respond to regulatory inquiries.
Plan laboratory trials, stability batches, and pilot runs; validate processes.
Lead cross-functional teams (PD, AD, QA, RA, Manufacturing) for project execution.

Education

M.Pharma (Pharmaceutical)

Job description

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 and review SOPs and prepare response for internal audits.
To review documents related to filter validation.
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).
To come up with innovative and patentable formulations proposals.
To come up with novel ideas which can reduce workload or expenses.
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.