Manager - Product Development (Sterile/Ophthalmic)
IT / Software Development & Related
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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 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 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
Skills
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About Company
Incorporated in 1990, Sentiss is committed to providing the best quality pharmaceutical products primarily in the Ophthalmic, ENT, and Inhalation segments. Over the past 25 years, by exhibiting commitment and showcasing our winning culture, Sentiss has evolved tremendously and is recognized as the third-best Ophthalmic Company (IMS 2015) in Russia. Sentiss’ footprint on the world map is a testimony to its quality philosophy and practice of product differentiation.
Sentiss strives to be a global leader in its core segment and continues to expand its operations in Russia, CIS, Europe, the USA, and Indian markets. Sentiss has a quality workforce of 700+ people across multiple geographies. Sentiss is recognized as one of the Top 100 Great Places to Work in India in 2015.
Since its inception in 1990, we have been continuously evolving and have crossed several milestones during this journey. Sentiss Research Centre (SRC) filed 50 patent applications out of which 9 patents have been granted till the end of Q2 2016.
Our key competitive advantage lies in having the R&D center together with the world-class manufacturing facility that has enabled us to provide end-to-end solutions from product development to marketing. Our manufacturing facility at Nalagarh (India) is EU GMP certified and TGA (Australia) approved. Sentiss is developing products for various countries. Over 1000 professionals in R&D, manufacturing, and sales & marketing are committed to delivering high-quality innovative products to customers.
Sentiss has forayed into the Indian market in October 2011 under the brand name PROVIS; by introducing a range of unique products through dedicated trained sales & marketing teams. Provis strives to redefine vision care in India by introducing unit dose preservative-free formulations. Provis has introduced products in disease segments like Dry Eye, Glaucoma, Ocular Nutrition, Allergy, Inflammation, and Infections through its dedicated team of sales and marketing professionals. Provis is expected to contribute significantly to the Indian eye care market.
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