Ranendu Ghosh

About Ranendu Ghosh

A Formulation Scientist by training with 13+ years of experience both from academic and professional fields I Scientist, mentor, and empathetic leader I * Key contributor and DP lead for successful approval of biosimilar Trastuzumab, Ogivri in US, EMA and other regulated markets, DP lead for development of Bevacizumab Abevmy, and Pegfilgrastim, Fulphila ** Biocon is a fully integrated biopharmaceutical company developing affordable biosimilars, novel biologics and complex APIs for diabetes, cancer, and auto-immune diseases. Its vision is to enhance global healthcare through innovation and affordability Team Lead and SME for Formulation and Drug Product Development (R&D) for Biosimilar MAb and other therapeutic parenteral, All aspects of CMC for formulation and DP development from early-stage to regulatory approval and life cycle management of commercial products- Formulation screening and selection for liquid and lyophilized drug products, Process development, optimization and characterization for the formulation, lyophilization, mixing, filtration, freeze-thaw, container-closure, Stability studies to support pre-clinical, clinical supplies and regulatory filing- Tech transfer to at-scale manufacturing (DS and DP), FMEA based risk assessment and identification of CPP, MOR, and PAR, Technical support for at-scale challenges, and devising mitigation strategies for formulation to aseptic fill-finish operation-Technical lead for drafting and reviewing regulatory CMC sections (S.2.6 and P.2), Hand on experience in MAA/BLA/post-approval supplements and variation filing submission for biosimilar injectables (Ogivri, Fulphila, and Abevmy), Technical support, and review of briefing book for EMA, FDA, and PMDA scientific advisory meetings*Collaboration: CFT collaboration and coordinaiton to identify provision of competitive proposals and creating marketing opportunities for drug products. Portfolio reviews for biologics programs, devise strategies to identify program deliverables and milestones, challenges mitigation strategies.*Leadership: Skilled in identifying talents and hiring, Set program goals for the team and conduct performance appraisal, Identification of career development and growth needs for the team, Outline personalized developmental plans, Build a connect at a personal and professional level to manage complex challenges through active and engaging participation.

Experience

1. Scientific Manager

   Biocon

   Mar 2015 — Present · Bangalore, IN

   Development, execute, drive and problem solving in - Assessment of patents to identify non-infringing formulation and process, Screening of appropriate formulation conditions to select lead candidates (for liquid and lyophilized drug products)DOE based process development and process characterization activities, FMEA based studies to identify CPP, PAR and MORStability studies (including In-use, infusion stability studies, forced degradation studies) required for process development, pre-clinical/clinical supplies and regulatory requirementsTech transfer to at-scale manufacturing for DS and DP, Technical support for at-scale activities and Process validation campaignFilter validation package, E&L studies, Support for shipping validation and other fill finish operations, scale up, site change and other pre approval activities. Lifecycle management for commercial products Justification and setting specifications for DS and DPTechnical lead for drafting and reviewing regulatory CMC sections (S.2.6 and P.2), Hand on experience in MAA/BLA/post approval supplements and variation filing submission for biosimilar injectables (Ogivri, Fulphila and Abevmy), Technical support and review of briefing book for EMA, FDA and PMDA scientific advisory meetingsLeadership and CollaborationCMC Lead and SME of the Formulation and DP group representing in portfolio review and other CMC forums to drive the project strategy and alignment with the program deliverables, Resource forecasting, budgeting and review of program Gantts with the alignment of cross functional teams Continuous collaboration with cross functional teams involving R&D, IP, Manufacturing, Operations, Quality, Regulatory, Supply chain, Program Management, CMO and CROs, External collaborator and consultants, Business partnersHiring and performance appraisal for the team, Skilled in identifying talents and continuous development

Education

• Indian Institute of Chemical Biology

  Doctor of Philosophy (PhD)

  2007 — 2013