Experience

Emergent BioSolutions

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr. Manager

  • May 2022 - Present

  -Responsible as product development team lead and CMC lead on development programs. -Manage remotely, ongoing technical programs at CMOs. -Manage cross-functional product development team. -Responsible as product development team lead and CMC lead on development programs. -Manage remotely, ongoing technical programs at CMOs. -Manage cross-functional product development team.



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Team Lead / Principal Scientist (Prog. Management as additional responsibility)

  • Oct 2016 - Apr 2022

  -Managed the Tech. Ops. Team supporting New Product Introductions activities such as Process Development, Clinical Supplies, Site Qualification, Demonstration, Validation, Cleaning Validation, Continuous process Verification, Cleaning Validation etc. -Project management for internal NPI projects, TPM projects (Third Party Manufacturing), cross-site transfer projects (as additional responsibility). -Successfully led multiple cross functional teams as SME for resolution of several complex technical issues/investigations. -Led multiple continuous process improvements for yield improvements and developing seamless and robust processes. -New technology and products assessment & evaluation, Long range planning (LRP), alternate material sourcing for assurance of supplies. -Supported Regulatory Audits (HPRA, FDA etc). -Mentoring and training Tech Ops and Operation colleagues. Show less



Catalent Germany Schorndorf Gmbh

• Schorndorf, Baden-Württemberg, Germany

• Principal Scientist

  • Aug 2015 - Oct 2016

  - Responsible for leading team accountable for formulation, process development & scale-up activities and commercial trouble shooting. - Leading external customer technical programme management. - Key projects involved process optimization of SR tablet, scale-up of fluid-bed coating process, process development of powder for sachet filling, scale-up of a capsule formulation by HSG, troubleshooting of MR coating of soft gelatin capsules at commercial scale. - Responsible for leading team accountable for formulation, process development & scale-up activities and commercial trouble shooting. - Leading external customer technical programme management. - Key projects involved process optimization of SR tablet, scale-up of fluid-bed coating process, process development of powder for sachet filling, scale-up of a capsule formulation by HSG, troubleshooting of MR coating of soft gelatin capsules at commercial scale.



Zoetis (Pfizer)

• Navi Mumbai, India

• Sr. Research Scientist

  • Sep 2012 - Jul 2015

  - Functionally designated as of Pharmaceutical Science Team Lead (PSTL) at Zoetis (Pfizer) for projects with the responsibility of leading a Global cross functional team of colleagues up to Director level. - Prepared budgets and timelines, formulation & process strategy, managing progression, communication to the higher management. - Also responsible for managing formulation development and animal studies at CROs, including preparing scope of work, CRO evaluation and selection, tracking progress to key milestones. - Formulations worked include chewable tablet with combo-APIs, coated chewable tablet, parenteral formulation through aseptic filtration and a liquid premix formulation. - Managed transfer and qualification of equipment from one site to another. Show less



Ranbaxy

• Gurgaon, India

• Research Scientist

  • Oct 2009 - Sep 2012

  - Development of robust, stable, bio-equivalent and non-infringing generic formulations for Regulated markets (USA, Europe). - To design and conduct pre-formulation studies, formulation prototype development, formulation & process optimization and clinical manufacturing on assigned projects. - Planning and execution of Scale-up and Exhibit batches at manufacturing sites. - Compilation & review of product development & transfer documents. - Literature critique including patent search and prior-art evaluation. - Review of analytical data, stability study results & biostudy results and further decide on the action plan. - Response to regulatory queries related to product development. - Review of formulation laboratory activities & practices and drafting SOPs, if required, with support from QA and facilitating internal audits. Show less



Jubilant Organosys Ltd

• Research Associate

  • Jun 2007 - Sep 2009

  - Development of robust, stable, bio-equivalent and non-infringing generic formulations for Regulated markets (USA, Europe). - To design and conduct pre-formulation studies, formulation prototype development, formulation & process optimization and clinical manufacturing on assigned projects. - Planning and execution of Scale-up and Exhibit batches at manufacturing sites. - Compilation & review of product development & transfer documents. - Literature critique including patent search and prior-art evaluation. - Review of analytical data, stability study results & biostudy results and further decide on the action plan. - Response to regulatory queries related to product development. - Review of formulation laboratory activities & practices and drafting SOPs, if required, with support from QA and facilitating internal audits. Show less