Biotechnologist
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A highly motivated and proactive Biotechnologist (M. Tech) with 13+ years of experience in developing biosimilar processes and products following ICH guidelines. I am proficient in authoring and review of high-quality CMC source documents as per specific regulatory requirements and guidelines.
I have contributed in CMC section of multiple regulatory dossiers for regulated and semi-regulated markets. I have also supported R&D functions by conducting impact assessment and drafting risk assessment documents for regulatory and quality compliance. In my current role I ensure timely delivery of cross-functional technical documents by effective coordination between different functions.
I possess 6 years of people leadership experience with a track record of developing multiple bioprocesses.
Looking for a challenging role in the domain of regulatory affairs/ quality assurance/ drug development wherein I can contribute to the success of the team with my rich technical expertise and cross domain regulatory exposure while being resourceful, innovative, and flexible.
Scientific writing, review and Regulatory exposure
▪ Clear, concise scientific style of writing with excellent language skills.
▪ Proven track record of authoring multiple high quality and consistent scientific reports, protocols, SOPs requiring minimal quality check.
▪ Reviewed numerous functional and cross-functional documents with a high level of attention to detail ensuring right first-time documentation.
▪ Well versed with regulations of FDA, EMA and other global agencies, drafting upstream CMC sections of regulatory dossiers, formulation of query responses for regulatory authorities, Quality Management Systems (QMS), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Good Clinical Practices (GCP).
▪ Led a team of scientists and research associates for planning and execution of fed-batch runs in glass bioreactors, AMBR and Single use bioreactors (up to 200 L scale) as a part of process development & optimization.
▪ Technology transfer to manufacturing team for successful scale-up of bioprocesses till 1000 L scale using state-of-the-art disposable technologies.
▪ Designing process development studies using DOEs (JMP), analyzing and concluding results with statistical inference.
▪ Gap assessment of functional SOPs; management of equipment and lab.
▪ Authored various technical documents such as development reports, campaign summary reports, scale-up proposal, process consistency, process comparability, technology transfer and risk assessment documents as a part of upstream process development.
▪ Risk assessment and lab quality management.
▪ Handling quality incidents, change controls, Corrective and Preventive Action (CAPA).
▪ Supported Impact Assessment (IA), Verification Qualification (VQ) and GXP assessment of equipment.
▪ Served as functional quality SPOC during USFDA audit.
