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• Provide strategic and technical guidance to team of four Research scientists in Product Development and Process Engineering group for formulation, Drug Product (DP), Process development and Fill-finish manufacturing operations of Phase I- III and related CMC activities.• Managing development of Parenteral pharmaceutical process/product development and technology transfer of NDAs, BLAs and ANDAs projects for US and European markets.• CMC Process and DP lead to oversee DP fill-finish process and Tech Transfer for Mfg. in-house and at CDMOs/CMOs. Prepare RFPs, review and negotiate proposals from various clients.• CMC Lead for providing guidance to CMC functions on Phase 3 process readiness, process characterization and FMEA studies by Design of Experiment (DoE) for PV and BLA readiness.• Authored and review CMC sections (Module 3) for regulatory submissions for US and UK.• Expertise in development of lyophilization formulation, Lyo cycles based on thermal properties, and scale-up of the Lyo process for the clinical trials and commercial process. • Oversee CMO-based drug product fill finish process implementation and manufacturing of diverse portfolio of biologics and small molecules in early-stage, and late-stage development.• Oversight of product development and provide technical strategy for pre-clinical and clinical formulation development for vaccine antigen, bulk adjuvant, adjuvanted vaccine formulation, therapeutic antibody formulations. • Oversight of product development and provide technical strategy for pre-clinical and clinical formulation development for vaccine antigen, bulk adjuvant, adjuvanted vaccine formulation, therapeutic antibody formulations. • Proficient in literature search, reviewing IP opinion and patent search to remain current with recent developments in pharmaceutical research and regulatory requirements for NDA / ANDA products.•Work in cooperation with cross-functional clinical, regulatory and QA team, to plan andexecute pilot and pivotal bioequivalence studies on drug products and evaluation/interpretationof the (BE) bioequivalence/toxicology/adhesion/clinical data and DMPK.• Possess in-depth Statistical Process Control (SPC) knowledge (Minitab and JMP) to assess process performance and trend analysis.• Experience in reviewing SOPs, change control and deviation reports, batch records and technical manuals. Expertise in executing manufacturing/quality deviations, CAPA and change controls using “Trackwise” system.
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Manager Product Development And Process EngineeringBerkshire Sterile Manufacturing Aug 2022 - PresentLee, Ma, UsManaging Direct reports of team of Research scientists in product development and process engineering group.Responsible for Managing product development, optimization of formulation and troubleshooting formulation and manufacturing process for sterile parental drug products.Expertise in Lyophilization cycle development & Cake quality optimizationExpertise in development of lyophilization formulation, Lyo cycles based on thermal properties, and scale-up of the Lyo process for the clinical trials and commercial process. Overseeing process development, scale-up, and technology transfer of multiple parental formulations Oversee internal and CDMO-based formulation, drug product fill finish process, and device development for a diverse portfolio of biologics and small moleculesOversee CMO-based drug product fill finish process implementation and manufacturing of diverse portfolio of biologics and small molecules in early-stage, late-stage development, and through commercializationOversee and manage process characterization and process validation studies at CMOs.Establish and apply development phase-appropriate Drug Product CMC development concepts and standards in a resource responsible mannerManaging parenteral pharmaceutical process/product development and technology transfer of NDAs, BLAs and ANDAs projects for US and European markets. Oversight of product development and provide technical strategy for pre-clinical and clinical formulation development for vaccine antigen, bulk adjuvant, adjuvanted vaccine formulation, therapeutic antibody formulations.
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Senior Principal ScientistHikma Pharmaceuticals Jul 2020 - Aug 2022London, London, GbLeverage scientific expertise and hands-on leadership to develop pre-clinical and later phase clinical formulations. Providing oversight for various activities including, lab scale formulation development in the context of QBD, technology transfer to CMOs, CROs and application modules preparation. • Handpicked by senior leadership to deliver challenging projects with a strong impact on the company’s portfolio. • Design and manage formulation studies and device compatibility studies: Execute study design protocols, oversee study execution at CROs, review results and resolve deviations by collaborating with CROs and QA, and review/approve development reports for internal QMS.• Led development from lab scale prototype formulation development to FDA submissions (NDA/ANDA) while working with cross-functional teams, including analytical R&D, Clinical (Pharmacokinetics), regulatory affairs, QA, materials management and operations.• Shepherd best in class CDMO and CROs with respect to technology transfer, testing, registration batch manufacturing, documentation, process validation and launch. • Successfully managing team encompassing research scientists and technicians.• Provide oversight for 2 multi-million dollar projects annually (total R&D budget of $10 million).• As R&D lead, successfully built and manage coherent teams consisting of members from different functions such as regulatory, medical, clinical operations, QA and product development• Authored and reviewed, technical development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs. • Act as Subject Matter Expert (SME) for knowledge of FDA Guidelines, GMP regulations, ICH guidance regarding DP (Drug product) manufacturing and process control. • Preparation of “request for proposal” and oversee Master service agreements (MSA), and Statement of works (SOW), along with project management to govern the CDMO, CMO and CRO activities. -
Senior Principal ScientistHikma Pharmaceuticals Jul 2020 - Aug 2022London, London, Gb
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Senior Research ScientistRhodes (Purdue) Pharmaceuticals Nov 2016 - Jul 2020• Five plus years of research and development experience in pharmaceutical industry: Pre-formulation and feasibility studies in transdermal,topical, semi-solids,immediate/controlled release dosage forms and solid oral products.• Project Lead in formulation development and responsible for developing transdermal, topical, buccal products and oral solutions for IND/NDA and ANDA submissions.• Manging CROs/CMO/CDMOs in Designing experimental plans; performing pre-formulation studies and optimization of prototype formulations to support the manufacture of pilot batches, exhibit batches, validation batches.• Work closely with Analytical R&D to plan appropriate analytical testing and stability studies on development batches, exhibit batches and validation batches.• Write protocols and review batch records to carry out process development and evaluation studies, scale up and pivotal batch manufacturing for NDA / ANDA's submission to regulatory agency.• Expertise in Working in cooperation with crossfunctional Clinical, Regulatory, QA Team to plan and execute pilot and pivotal bioequivalence studies on drug products and evaluation of the BE, bioequivalence/adhesion/clinical/Toxicology data and DMPK.• Proficient in literature search and performing patent search to remain current with recent developments in transdermal drug delivery, as well as and generic pharmaceutical research and regulatory requirements for NDA / ANDA products.Specialties: Transdermal and Topical drug delivery, Transmucosal drug delivery, Oral drug delivery, Small Molecules, Medical Devices and combination products, in vitro assay development.
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Research Scientist FormulationsNoven Pharmaceuticals May 2015 - Nov 2016Miami, Florida, UsExperience in Pre-formulation, Formulation, and Process Development for branded (NDA) drugsCollaborate with Analytical R&D, Regulatory affairs and Clinical management TeamWrite and review product development reports for submitting to the FDAProficient in patent literature search, literature survey and reviewing IP opinionHands-on experience in formulation development, scale-up and process development aspects of Solid, Topical and Transdermal dosage forms -
Postdoctoral Research ScientistSri International Apr 2014 - Apr 2015Menlo Park, Ca, UsFormulation development of protein and small moleculesExpertise in transmucosal, transdermal and transbuccal deliveryPre-clinical and Pre-formulation studies of oral, transdermal and topical formulationsFormulation development by DOE using MiniTabProtein purification and characterization -
Graduate Student ResearcherSri International Dec 2013 - Apr 2014Menlo Park, Ca, Us
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Ph.D. Mercer UniversityMercer University 2010 - 2014Macon, Georgia, UsPh.D in Pharmaceutical SciencesMy research was focussed on transdermal and transbuccal delivery of small molecules and development of topical formulations. -
LecturerBr Nahata Group Of Pharmacy Institutes Aug 2008 - Aug 2010Responsibilities included teaching Anatomy, Physiology and Health Education, Inorganic Chemistry, Pharmacognosy and Physical Pharmacy. Conducting Pharmacognosy and Anatomy and Physiology laboratories. Mentoring of students and grading examinations and practicals. Guiding master’s student regarding their research projects.
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Trainee Business RepresentativeZydus Cadila Aug 2005 - Jan 2006Ahmedabad, Gujarat, In
Gaurav Bhatia Skills
Gaurav Bhatia Education Details
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Mercer UniversityPharmaceutical Sciences -
Rajiv Gandhi Prodyogiki VishwavidyalayaNatural Products Chemistry And Pharmacognosy
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Rajiv Gandhi Prodyogiki VishwavidyalayaPharmaceutical Sciences
Frequently Asked Questions about Gaurav Bhatia
What company does Gaurav Bhatia work for?
Gaurav Bhatia works for Berkshire Sterile Manufacturing
What is Gaurav Bhatia's role at the current company?
Gaurav Bhatia's current role is Manager Product Development and Process Engineering.
What is Gaurav Bhatia's email address?
Gaurav Bhatia's email address is bh****@****ail.com
What is Gaurav Bhatia's direct phone number?
Gaurav Bhatia's direct phone number is +167844*****
What schools did Gaurav Bhatia attend?
Gaurav Bhatia attended Mercer University, Rajiv Gandhi Prodyogiki Vishwavidyalaya, Rajiv Gandhi Prodyogiki Vishwavidyalaya.
What are some of Gaurav Bhatia's interests?
Gaurav Bhatia has interest in Children, Economic Empowerment, Education, Science And Technology, Health.
What skills is Gaurav Bhatia known for?
Gaurav Bhatia has skills like Formulation, Hplc, Drug Delivery, Pharmaceutical Research, Uv/vis, Pharmacokinetics, Protein Purification, Uv/vis Spectroscopy, Fluorescence Spectroscopy, Size Exclusion, Confocal Microscopy, Microneedles.
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