Experienced downstream processing professional with a focus on optimizing biopharmaceutical manufacturing processes. Skilled in the purification with strong foundation in chromatography, filtration, and other downstream techniques. With a keen eye for detail and a commitment to quality, I ensure compliance with regulatory standards while maximizing yield and efficiency. Proficient in troubleshooting and process optimization, I excel in driving continuous improvement initiatives to enhance productivity and product quality. Collaborative by nature, I thrive in cross-functional teams, leveraging strong communication skills to achieve common goals. Passionate about contributing to the development of life-saving therapeutics, I am dedicated to advancing the biopharmaceutical industry through innovative downstream processing solutions."
Overview
12
12
years of professional experience
Work History
Manager
Gennova Biopharmaceuticals
06.2020 - Current
Developed and implemented streamlined processes and requirement gathering to meet organizational objectives.
Preparation of essential documentation including project summary, development reports, feasibility studies, and Material Safety Data Sheets (MSDS).
Utilized Agile methodology to ensure efficient project delivery, enhancing adaptability and responsiveness.
Crafted Standard Operating Procedures (SOPs) tailored for vaccine projects, ensuring compliance with quality and regulatory standards.
Managed troubleshooting efforts for deviations during scale-up and transfer processes, ensuring smooth transitions.
Planned and executed meticulously designed experiments, providing innovative solutions for process development challenges.
Maintained communication with stakeholders, offering regular updates on project progress and milestones.
Conducted comprehensive risk analyses for development and transfer initiatives, implementing proactive mitigation strategies.
Prepared site feasibility documentation and gap identifying documents for seamless transitions to manufacturing.
Contributed to patent writing documentation efforts, safeguarding intellectual property and fostering innovation.
Oversaw manufacturing of GMP-grade batches, ensuring smooth batch processing.
Responsible for maintaining QA-related tasks in alignment with DSP lab requirements, including updating SOPs, URS, IQ, OQ, and validation reports.
Assistant Manager
Gennova Biopharmaceuticals
10.2018 - 05.2020
Spearheaded the development of processes for specified targets, paving the way for in-depth organizational study and analysis.
Contributed to patent writing documentation, safeguarding intellectual property and promoting innovation within the organization.
Assisted in preparing C3 forms for submission to the Drug Controller General of India (DCGI), ensuring compliance with regulatory requirements.
Led all quality assurance (QA) activities to establish laboratory operations at a new location, ensuring seamless setup and adherence to standards.
Conducted comprehensive risk analyses for both development and transfer initiatives, identifying potential areas of concern and implementing proactive mitigation strategies.
Played a key role in clone selection for mAb and subsequent purification processes, contributing to the advancement of therapeutic development initiatives.
Prepared essential documentation including project summary, development reports, feasibility studies, and Material Safety Data Sheets (MSDS).
Utilized Agile methodology to ensure efficient project delivery, enhancing adaptability and responsiveness.
Executive
Gennova Biopharmaceuticals
10.2015 - 03.2018
Conducted thorough requirement gathering and established foundational details for specified targets.
Designed and executed experiments to attain desired outcomes, ensuring precision and accuracy in results.
Developed and optimized processes to achieve efficient scale-up and successful transfer to large-scale manufacturing.
Participated in the preparation of Quality Assurance documents pertinent to project work and facilitated audits.
Conducted meticulous data analysis and documentation to support seamless transfer to large-scale production.
Officer
Gennova Biopharmaceuticals
10.2013 - 03.2015
Conducted comprehensive requirement gathering to ascertain project objectives and specifications.
Executed a range of experiments for each project, ensuring alignment with specified criteria.
Analyzed available data and tailored experiments accordingly to optimize outcomes.
Developed and refined processes for both targets, ensuring seamless transfer to production environments.
Trainee Officer
Gennova Biopharmaceuticals
10.2012 - 03.2013
Engaged in ongoing projects to deepen understanding of processes and methodologies.
Acquired proficiency in utilizing various instruments and tools essential for project execution.
Spearheaded meticulous projects, serving as the primary liaison from the department, ensuring seamless coordination and communication.
Trainee
Serum
Pune
03.2012 - 08.2024
Received training in industry-standard purification concepts, enhancing proficiency in downstream processing techniques.
Executed operations on downstream equipment such as Tangential Flow Filtration (TFF) and Chromatography, ensuring efficient product purification.
Successfully conducted multiple batches for Dynamic binding capacity (DBC) study, achieving targeted objectives and maintaining quality standards.
Proficiently performed High-Performance Liquid Chromatography (HPLC) and conducted polysaccharide-related analytics, contributing to accurate analysis and product characterization.
Skills
Chromatography systems working on Unicorn software
Column packing and unpacking
Tangential flow filtration techniques
Designing experiments on MODDE (DOB software)
Team Management
Stakeholder Management
Documentation Skills
Planning and Monitoring
Elicitation Techniques
Gap Analysis
Root Cause Analysis
Feasibility Study
Operating Systems - Windows 7, 81, 10
Cross-Functional Teamwork
Time Management
Office-Suit- MS-Office, MS-Visio
Academic Credentials
M.Sc.(Biotechnology) from Ganapat University, Ahmedabad, Gujrat.
B.Sc. (Biochemistry) from Holkar science college, Indore, M.P.
SSC and HSC from Kendriya vidhyalaya, Delhi.
Training
Participated in a workshop focused on the commercial aspects of Bioinformatics, DNA fingerprinting, and Forensic science, organized by PIBMS.
Attended a seminar conducted by Dr. Pratiksha Joshi on "In Vitro Fertilization", gaining valuable insights into reproductive technologies.
Completed a 10-day training program in the IVF lab at the Department of Obstetrics and Gynecology, Institute of Kidney Disease and Research Center, Ahmedabad.
Undertook a 6-month training as a BCIL trainee at the Serum Institute of India Ltd., specifically in the R&D Pneumococcal department under the mentorship of Mr. S K Jana.
Proficient in creating Requirement Traceability Matrix (RTM), ensuring comprehensive coverage of project requirements throughout the development lifecycle.
Skilled in writing user stories and adept at facilitating meetings, enhancing communication and collaboration within project teams.
Well-versed in Software Development Life Cycle (SDLC) methodologies, including Agile, Waterfall, and Scrum models, ensuring effective project management and delivery.
Disclaimer
I hereby declare that the details furnished above are true and correct to the best of my knowledge and belief and I undertake to inform you of any changes therein, immediately.
Research and Development Executive at Gennova Biopharmaceuticals Vaccine Formulation and Research CenterResearch and Development Executive at Gennova Biopharmaceuticals Vaccine Formulation and Research Center