Paras Jain Email & Phone Number

India

Hyderabad, Telangana, India

India

Hyderabad, Telangana, India

Hyderabad Area, India

ANDA Development: Ensuring in house development & delivery of 10+ solid oral products for regulated market. The products include high value FTFs and complex oral controlled release dosage forms. Responsible for technical management of outsource development of products. Responsibilities include clearing intellectual property, clinical, regulatory hurdles for in time delivery of high quality products.IND & NDA Development: Handling development & supply of clinical & preclinical material of NCE molecule pipeline. Early identification of differentiation opportunity & creating intellectual property for the same.Research & Delivery Management : Technical feasibility evaluation of project proposals, Drawing timelines for approved projects, budgeting for financial year, identifying bottlenecks and identifying solutions, coordination with licensing, sourcing, business, service providers & suppliers for timely delivery.Laboratory set up from scratch: Engineering design, Utility & Facility requirement finalization, Purchase, Excise waiver documentation, Regulatory Licensing, Qualifications, safety management, waste management, Implementation of laboratory procedures & guidelines. Material & investigational product management.Quality by Design: Leading implementation of QbD elements (Risk assessment, soft tools, DoE, Design space & control strategy) during development.Personnel Management & Development: Managing team of scientists, identifying development needs, Teambuilding for successful delivery. Mentoring engineering & licensing resources.

Gurgaon, India

• Formulation Development professional with more than 9 years of experience. including 2 years of international working exposure in an innovator environment.• A dedicated team player, managing deliveries through team of 6 scientists. Proven personnel management, Interdepartmental co-ordination skills.• Specialized in development of Generics, Super generics, Differentiated Technologies, NDAs for regulated market (USA, Canada, Europe)• Exposure to Ideation and development of differentiated formulation technologies. Identification of molecules having unmet clinical needs & evaluating such product proposals in coordination with cross functional teams.• Successfully delivered multiple complex modified release formulations. Instrumental to organization`s high value deliveries. Successfully developed literature based anticipated FTF.• Excellent understanding of factors affecting BA/ BE success, exploratory IVIVC modeling for discriminatory media development. Experience of IVIV modeling using winnonlin & PK modeling using Gastro plus.• Spearheading new initiatives of Accelerated Stability Assessment Program (ASAP) for model prediction of shelf life, science based formulation & pack development, shortening lab to clinic time.• Excellent understanding engineering and scale correlation aspect which has helped in multiple successful process development campaigns, trouble shooting, failure investigation & query responses.• Excellent in Quality by Design have helped functional implementation of scientific risk assessment & design of experiments (DoE) in multiple projects. Current job profile includes mentoring critical projects for implementation and building consensus between cross functional teams.• Excellent in technical query response skills which has saved critical deliveries. • Spearheading introduction and implementation of sophisticated Material Characterization Techniques to the function. Current job profile includes facilitation of characterization studies.

Hiratsuka, Shinagawa

Formulation Research, QbD, PAT, Simulations, Project Management- Consistent performer with broad experience in development of solid orals.- part of organisation's prestigious "Talent Exchange Programme"- Performed in diverse international cultures demonstrating highly adoptive and performance oriented attitude with great interpersonal skills.- Specialised in development of formulations for clinical trials, ANDA and NDA filings.- Excellent in development and successful technology transfer of complex modified release formulations.- bring whole new perspective to QbD and its application for successful development and technology transfer.- Strategy for application of material characterisation techniques for identification of risks in early development.- Part of technology enhancement teams for application of new technological initiatives such as continuous manufacturing consigma-1, NIR and Terahertz process analytical tools, soft tools such as FBRM, Thermal Effusively. Simulation technics based on DEM & FEM.- Exposure to CMC planning and professional project management practises of innovation based organisation.- Excellent in technical query response, saved critical deliveries with sound scientific justifications.- Proven track record of failure investigation, Supported products across the teams.- Good understanding of pk simulation using gastroplus, IVIVC using winnonlin. Development of discriminatory media for increased BA/ BE success rate. - Valuable insight for lab to market success in Japan market and strategy for brand creation. Worked closely with experts, Hospitals and Pharmacies to understand this.

- Strategizing and developing complex modified release dosage forms for US, Europe and Canada market. - The developed formulations include extended release tablets, extended and delayed release multi-particulate drug delivery systems, push pull type osmatic tablet dosage forms. - Application QbD principles in the development. Advance level knowledge of DoE and experience in guiding multiple development projects for application of DoE.- Experience in scaling up of multiple complex products with excellent analytical and trouble shooting abilitites.- Proven technical query response and failure investigation skills. - BA/ BE data interpretation and development of discriminatory media.- Effective interdepartmental coordination for timely delivery of products.- Excellent understanding of instrumental technology, especially fluid bed technology and efforts for infrastructure improvement.

- Worked in Oral Controlled Release Systems (NDDS) Department. Handled Multiple projects of SR & MR Formulations. - Self motivated efforts for successful delivery has helped me understand end to end generic development, right from material sourcing, through development, filing, query response and successful launch. Played Key role in successful delivery of high value products. - have accomplished Challenging assignments with technical assessment of failures. Instrumental to application acquired knowledge to other products which helped the group gain technical expertise. - Was instrumental for Technical dialog on agency queries, which was key for saving cost and delivery.

Hyderabad Area, India

- Part of team who initiated custom pharmaceutical development department.- Developed two 505(b)(2) once a daily extended release oral formulations for reduced dosing frequency of an existing IR listed drug.- Multiple formulation strategies tried. Finally wurster based process and formulation was successfully scaled up and validated. - The process parameters were optimized using DoE. One of the early QbD applications in Indian Pharma Industry.- One IR tablet formulation was developed for first in human (Phase-1) trials.

Master Of Pharmacy

Bachelor Of Pharmacy, Pharmaceutical Sciences

Diploma In Pharmacy, Pharmaceutical Sciences