Topical Formulation Development

Topical Formulation Development - US ANDA Formulation DevelopmentTeam Management Project ManagementTechnology Transfer (Process optimization batches, Scale up, Exhibits) Regulatory support (Formulation CMC)Stakeholder management

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Provide deep technical expertise in developing high-quality skincare (Topical formulation) drug products following US-FDA and ICH guidelines and lead a development team with a demonstrated history of multiple US-FDA-approvals.❖ Lead formulation development projects throughout the lifecycle, including project planning, schedule, risk assessment, procurement, execution, documentation, regulatory submission support, partner with project leaders to… Show more 𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Provide deep technical expertise in developing high-quality skincare (Topical formulation) drug products following US-FDA and ICH guidelines and lead a development team with a demonstrated history of multiple US-FDA-approvals.❖ Lead formulation development projects throughout the lifecycle, including project planning, schedule, risk assessment, procurement, execution, documentation, regulatory submission support, partner with project leaders to manage budgets, resources, and timelines to complete projects.❖ Lead formulation development projects throughout the lifecycle, including project planning, schedule, risk assessment, project procurement activities, and project execution. Partner with project leaders to manage budgets, resources, and timelines to complete projects.❖ Prepared QbD - DOE-based product development reports and draft formulation relevant regulatory sections and post-submission FDA IRL/CRL/DRL responses for timely US-FDA approvals.❖ Collaborate with multidisciplinary teams comprising Business Development, Project Management, Analytical Development, Intellectual Property Management, Regulatory Affairs, Quality Assurance, Technology Transfer, Manufacturing facility, Engineering, External vendors, CMO, CDMO, CRO.❖ Lead and manage scientific evidence-based technology transfer activities from the R&D to manufacturing line for scale-up and Exhibit batches.Drive productivity improvements and efficiencies in the laboratory environment to deliver cost-effective quality R&D output. Support facility set-up space, floor plan, vendor selection, M/C’s selection, FAT, material selection, quotations, and negotiations with strong US-FDA, ICH, and GMP guidelines acumen. Show less

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Spearheaded the topical formulation R&D development pipeline ❖ Participated in the US-FDA audit as a part of the R&D team. Help build in-house In-vitro testing capabilities.❖ Supported the responses to US-FDA information requests and CMO audit observations❖ Managed technical communication with top CRO's in the US for In-vitro release testing (IVRT) and In-vitro skin permeation testing (IVPT).

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖Initiated two ANDA with detailed project literature❖ Prepared and presented project kick off slides to stake holders ❖ Designed QbD templates, formulation strategies, lab notes, sampling protocols, stability reports, specifications, scale up formats, Master Formula Card (MFC), and other tech transfer documents, reviewed bilingual BMR❖ Sourced reference listed drugs, APIs, excipients, packaging material, laboratory equipment❖ Drafted… Show more 𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖Initiated two ANDA with detailed project literature❖ Prepared and presented project kick off slides to stake holders ❖ Designed QbD templates, formulation strategies, lab notes, sampling protocols, stability reports, specifications, scale up formats, Master Formula Card (MFC), and other tech transfer documents, reviewed bilingual BMR❖ Sourced reference listed drugs, APIs, excipients, packaging material, laboratory equipment❖ Drafted project specific US FDA controlled correspondences❖ Optimized formulations using DOE design, Written Product Development Report in line with US-FDA & ICH requirements❖ Timely reviewed analytical data to find out critical challenges❖ Handled Project transfer activities from lab scale to exhibit scale at different CMO. ❖ Timely project communication with CROs / CMOs❖ Executed EB batches, ANDA filling, Query response Show less

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Worked with the Director for the Topical Formulation Development lab setup, including vendor selection, quotations, procurement, installation (IQ, OQ, PQ), calibration plan, SOPs of lab equipment. ❖ Managed scientific project planning and strategic execution of the topical drug product formulation composition and process development, packaging material development, technology transfer, scale-up, exhibit activities based on established goals and… Show more 𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Worked with the Director for the Topical Formulation Development lab setup, including vendor selection, quotations, procurement, installation (IQ, OQ, PQ), calibration plan, SOPs of lab equipment. ❖ Managed scientific project planning and strategic execution of the topical drug product formulation composition and process development, packaging material development, technology transfer, scale-up, exhibit activities based on established goals and project timelines. ❖Managed four topical drug products till successful US-FDA ANDA submissions and one 505 (b) (2) topical cream project till patent application. Executed Minitab (DOE software) based experiments to optimize formulation compositions and process parameters. ❖ Performed lab duties, maintained product-specific Lab Note-Books (LNB), literature, QBD templets, Stability protocols, FDA controlled correspondences (CC), Inactive Ingredients Database (IID) clearance, Patent landscape review reports, Analytical reports, project files and records, SAP records., project file, GMP quality system training, onboard training records, SOP training, calibration records.❖ Team player in multiple collaborative activities, R&D Technology Transfer, Scale-up, Exhibit batch execution, drafting reports, including but not limited to control strategy, PD report, data analysis and summary reports, and FDA query responses and Participated in DOE software training (Minitab), QBD training, and Onboarding residential induction program (15 days). Show less

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Contribution in set up of topical formulation development lab for derm formulation development, such as procurement, installation (IQ, OQ, PQ) and calibration of instruments and equipment required for development and evaluation dermal products. ❖ Initiated development of two ANDAs & one 505 (b) (2)

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Developed topical and liquid oral formulations for semi-regulated and Indian market (cream, gel, ointment, lotion, suspension, shampoo, powder, natural extracts gel, and sunscreen)❖ Worked with stakeholders- Analytical, Regulatory, Quality Assurance, Patent, Packaging, Manufacturing facility, CMO, and clinical development team.❖ Drafted product rationales and forms for local FDA / CDER approvals❖ Handled sourcing and procurement for… Show more 𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Developed topical and liquid oral formulations for semi-regulated and Indian market (cream, gel, ointment, lotion, suspension, shampoo, powder, natural extracts gel, and sunscreen)❖ Worked with stakeholders- Analytical, Regulatory, Quality Assurance, Patent, Packaging, Manufacturing facility, CMO, and clinical development team.❖ Drafted product rationales and forms for local FDA / CDER approvals❖ Handled sourcing and procurement for RLD/API/Excipients and packaging material❖ Performed technology transfer of developed procedures to scale up activities at various CDMO Show less

𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Formulation Development of Cyclobenzaprine Hydrochloride IR Tablet 5mg/10mg for brazil market Contribution during the Internship: ❖ Formulation Development of ‘NCE’ (GRC-8200 tablet)❖ Formulation development of Tranexamic / Mefenamic acid IR tablet and Gabapentin Capsules