Suneel Rastogi Email and Phone Number
New York, NY, US
Suneel Rastogi's Location
New York City Metropolitan Area, United States, United States
Suneel Rastogi's Contact Details
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About Suneel Rastogi
Pharmaceutical professional with over 25 years of experience in effectively managing internal and external development projects. In-depth knowledge and extensive experience in managing all aspects and stages of product development including pre-formulation, materials characterization, formulation and process development, analytical development, novel technology development, scale-up, and commercial launch of dosage forms. This core strength is augmented by considerable knowledge of quality, regulatory, biopharmaceutics and clinical aspects. • Managed 100+ projects at various stages of product development including many challenging high value blockbuster brand as well as generic products. Led the due diligence on over 150 products for acquisition, in-licensing or co-development. Projects include oral dosage forms, injectable, long acting, amorphous solid dispersions, ophthalmic and topical products nano particulates, peptides, nasal sprays, rectal gels, drug device combination products, implants, sterile auto-injector, etc. Led the due diligence of companies for acquisition, external contract development and manufacturing organizations and contract research organizations based on technical capabilities, regulatory compliance history, documentation practices, policies and procedures.• Established new R&D Lab for a start-up company by hiring and team building, implementing systems and procedures, installing new equipment and instruments. • Developed novel pharmaceutical applications and formulation platforms based on semi-conductor technologies. Developed and executed comprehensive strategy to de-risk the technology for regulatory and market acceptance.• Business development and technical marketing through technology introduction to potential customers, managing relationships with customers across global locations and evaluation of market and competition.
Suneel Rastogi's Current Company Details
Suneel Rastogi Work Experience Details
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Senior Director, R And D Formulation DevelopmentCmic Cmo UsaNew York, Ny, Us
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Senior Director, Research And DevelopmentVici Health Sciences May 2023 - PresentElkridge, Maryland, UsResponsible for providing strategy and guidance on ongoing projects while ensuring scientific rigor and timeliness during various stages of product development. These projects include those intended for 505(b)(2) and ANDA filings. Product types include solid and liquid oral, sub-lingual, buccal, topical, lipid based formulations, controlled release and peptide delivery. Major responsibilities include• New Product Development: Developed product designs and detailed developmental strategy (including pre-formulation, quality by design, formulation / process development, technology transfer, GMP manufacturing, stability testing, clinical and regulatory filing strategies) while ensuring achievement of both technical and business requirements. • Performance Improvement of Commercial Products: Implemented formulation and process changes within SUPAC level 1 in order to enhance the uniformity of dosage, dissolution performance and product stability.• Business Development: Introduce new clients and bring in new capabilities. Write blogs, case studies and presentations to showcase company capabilities. Attend tradeshows and conferences to network with potential customers. Evaluate new projects based on product complexity, regulatory and IP constraints, customer requirements and internal capabilities. Interface with clients to provide solutions based on their unique needs. Develop and execute project proposals. Regular customer interactions for update and feedback.• Intellectual Property Development: Draft patent claims to protect new technologies. Generate technical data to demonstrate industrial applicability. Review prior art to develop non-infringement strategies. • Training and Supervision: Train and guide new scientists in various aspects of product development and regulatory filings. -
Director, New Technology Development And Product MarketingApplied Materials Jul 2020 - Apr 2023Santa Clara, Ca, UsDeveloped and executed overall strategy for development of novel pharmaceutical applications, formulation platforms and drug products based on Applied Materials’ proprietary technology. Created and implemented a comprehensive plan to de-risk the new technology by identifying and eliminating regulatory and market hurdles. Managed relationships with external partners across global locations including big pharma companies to identify their high value problems and provide differentiated solutions. Major accomplishments:• New Products, Applications and Platform Formulations Development: Developed and demonstrated novel pharmaceutical applications and formulation platforms in the areas of high drug loaded amorphous solid dispersions, modified release, long acting injectables, stability enhancement, bioavailability enhancement, nanoparticulate delivery, small and large molecule delivery and continuous manufacturing. Spearheaded the ideation, refinement and validation of product concepts for 505(b)(2) applications. Coordinated projects through internal team, external CDMOs, consultants and KOLs. • Regulatory Strategy: Developed a comprehensive framework to de-risk the new technology by identifying and removing regulatory and market hurdles including those related to composition, characterization, process, pre-clinical safety, regulatory and quality. Educated the team regarding the challenges and milestones in safety evaluations and clinical readiness of novel pharmaceutical ingredients and technologies. • New Business Development and Technical Marketing: Introduced technology to potential customers through meetings, workshops, webinars and conference presentations highlighting unique capabilities and value proposition. Onboarded several big pharma customers to implement Applied Materials’ technology for pipeline projects. Evaluated, selected and set-up partnerships with clinical research organizations (CRO’s) and CDMOs and consultants. -
Senior Director, Product DevelopmentNavinta Llc Dec 2019 - Jul 2020Responsible to lead the design, development, filing, launch and technical support of simple and complex generics as well as 505B2 products. Formulated overall development strategy for various projects including API sourcing, product design, characterization of complex API and products, bioequivalence studies, regulatory filings and patent evaluations. Served as an in-house expert in the physico-chemical characterization of pharmaceuticals.• New Product Development: Led the development of a variety of products such as solid oral dosage forms, injectables, long acting injectables, nano particulates, peptides, nasal sprays, rectal gels, drug device combination products and implants. Responded to ANDA deficiencies. Implemented systems and procedures to streamline and track projects. • New Projects Selection: Led technical assessment to select product portfolio based on product complexity, API / RLD availability, bioequivalence requirements, equipment / facility requirements, patents, exclusivities and competitive landscape.• Managed External Partnerships: Collaborated with numerous universities and national labs for physicochemical characterization of complex products such as nano particulates and peptides.
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Senior Director, R&DLeading Pharma, Llc Sep 2017 - Dec 2019Fairfield, Nj, UsReporting directly to company President, was responsible for setting up the R&D laboratory and managing a group of 12-14 scientist engaged in execution of all aspects of generic pharma R&D activities including preformulation, formulation, process development, method development and biopharmaceutics. Mobilized the team, to achieve desired milestones and meet aggressive timelines with limited resources and budgetary constraints. Provided leadership, vision, overall strategy and direction to the product development team. Major accomplishments include: • Established a New R&D Lab (Formulation, Analytical and Pharmacokinetics): Hired and trained staff to build a strong collaborative, well-functioning R&D team of scientists. Built capability by purchasing and installing processing equipment and analytical instruments critical for expediting product development. Implemented systems and procedures - created SOP’s and implemented changes to ensure alignment with current regulations, policies, and practices. • Development and Regulatory Filing of Generic Products: Designed and executed product development strategies from concept to prototype formulation design, scale-up, process optimization, technology transfer, biostudies and regulatory filing. Developed extensive timelines and detailed project plans. Developed bioequivalence strategies and coordinated BE studies with CROs. Prepared regulatory submission documents including Product Development Report, Quality Overall Summary and other relevant ANDA sections. • R&D Portfolio Selection: Evaluated new products in collaboration with business development & regulatory affairs. • Product Due Diligence: Coordinated, compiled, analyzed and summarized the technical input from R&D functions to create concise presentations for the senior leadership. • Managed the interaction with external partners such as consultants, API venders, CROs and CDMOs. Evaluated CDMO’s for possible technology transfers. -
Director, Formulation Development And PreformulationImpax Laboratories Mar 2011 - Jul 2017Hayward, Ca, UsReporting directly to the Chief Scientific Officer, was responsible for overall design and development of robust products that were non-infringing, scalable, stable and bioequivalent to the reference product. Introduced QbD and scientific rigor to product development. Helped company come out of FDA warning letter by remediating and improving the robustness of products / processes and providing technical support necessary to close outstanding Quality plans / CAPAs associated with deficient projects. Assisted in product portfolio selection by ranking the projects based on technical complexity and challenges. • Development of new products: Led a team of 10-12 scientists (including 1-2 managers, 4-5 Ph.D.’s) to develop products based on review of scientific literature, patents, drug substance physicochemical properties, pharmacokinetics, reverse engineering, regulatory, marketing and manufacturing requirements. Managed 10-20 active projects at a given time in various phases of development ranging from lab scale to product launch. Responded to ANDA deficiencies.• External Development: Led due diligence of companies, sites and products for potential acquisition. Managed externally developed BD&L products (in-licensing, co-development). Coordinated external manufacturing activities. • Preformulation R&D: Organized and led the preformulation group as a well-integrated center of excellence for basic scientific investigation with the mission to help enhance the understanding of products, processes and methods. • Project Management: Managed day-to-day operations for formulation development, scale-up and technology transfer. Managed resource allocation, workflow, budget, planning, timeline and scheduling of product development activities. Conducted cross functional project team meetings. -
Research Manager, Product DevelopmentMallinckrodt Pharmaceuticals Jul 2005 - Mar 2011Dublin, Ireland, IeSuccessfully led the development and filing of simple immediate release as well as complex modified release generic products. Planned and implemented formulation design strategies to develop generics for products with comprehensive innovator patent protection, complex structures and unique pharmacokinetic profiles. Most prominent product developed was the generic of Concerta Tablets that generated $billion plus annual sales. Major accomplishments include: • Demonstrated Leadership Skills o Mentored, trained and supervised a team of 8-10 formulation and analytical scientists (including 3 Ph.D.’s) through the product development cycle and explained with clear objectives the scope, rationale, expectations and business implications. Attended to their training and profession development needs. Provided prompt and candid feedback. o Coordinated and supervised development activities including formulation development, process optimization, scale-up, clinical supply manufacture, technology transfer to internal and external contract manufacturing sites. Managed general resource allocation, planning, scheduling and evaluation of reporting scientists. • Demonstrated Scientific Rigor o Planned and performed project related scientific/technical activities such as design of experiments, data analysis, interpreting results, troubleshooting, drawing relevant conclusions, and careful documentation of all work. Implemented the applications of six-sigma tools in pharmaceutical development. o Conducted characterization of drug substances and reverse engineering of innovator products. Developed analytical mapping techniques to characterize complex dosage forms. • Gained proficiency in processing and handling of potent compounds and narcotic / controlled substances. -
Senior Research ScientistForest Laboratories, Inc. Nov 1999 - Jul 2005Successfully developed tablet, encapsulated bead and liquid oral formulations for ethical drugs (brand products). Developed formulations with a range of modified release characteristics for drugs with a variety of physico-chemical and biopharmaceutical properties and at various stages of development. Wrote strong patents to maximize profitability. • Proven Track Record of Success: Among other products, developed formulation (OB Patent # US8039009) for Namenda XR, a multi-billion dollar per year blockbuster drug. • Extensive Hands-On Experience in Formulation Development: Used conventional and specialized pharmaceutical technologies. Characterized and evaluated dosage forms based on physicochemical properties, analytical data and stability. Manufactured clinical supplies – well versed in cGMP procedures. Authored and reviewed technical reports, PDRs, IND sections, batch records, protocols, and SOPs. • Preformulation and Material Characterization: Educated and trained the company about polymorphism and solid-state related issues through presentations and discussions. Reviewed API characterization data for potential solid-state issues. Assisted in selection of suitable polymorphs, solvates or salt forms of new drugs.
Suneel Rastogi Skills
Product Development
Six Sigma
Technology Transfer
Drug Delivery
Formulation
Pharmaceutical Industry
Pharmaceutics
Fda
Regulatory Affairs
Gmp
R&d
Drug Development
Biopharmaceuticals
Generic Programming
Regulatory Submissions
Manufacturing
Process Simulation
Research And Development
U.s. Food And Drug Administration
Suneel Rastogi Education Details
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University Of MinnesotaPharmaceutics -
Indian Institute Of Technology (Banaras Hindu University), VaranasiPharmaceutics
Frequently Asked Questions about Suneel Rastogi
What company does Suneel Rastogi work for?
Suneel Rastogi works for Cmic Cmo Usa
What is Suneel Rastogi's role at the current company?
Suneel Rastogi's current role is Senior Director, R and D Formulation Development.
What is Suneel Rastogi's email address?
Suneel Rastogi's email address is su****@****ien.com
What is Suneel Rastogi's direct phone number?
Suneel Rastogi's direct phone number is +173266*****
What schools did Suneel Rastogi attend?
Suneel Rastogi attended University Of Minnesota, Indian Institute Of Technology (Banaras Hindu University), Varanasi.
What skills is Suneel Rastogi known for?
Suneel Rastogi has skills like Product Development, Six Sigma, Technology Transfer, Drug Delivery, Formulation, Pharmaceutical Industry, Pharmaceutics, Fda, Regulatory Affairs, Gmp, R&d, Drug Development.
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