Summary
Overview
Work History
Skills
Academic Credentials
Training
Disclaimer
Languages
Timeline
Generic

ADITI LAGHATE

Pune

Summary

  • 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.

Languages

Marathi
First Language
Hindi
Proficient (C2)
C2
English
Proficient (C2)
C2
Gujarati
Advanced (C1)
C1

Timeline

Manager

Gennova Biopharmaceuticals
06.2020 - Current

Assistant Manager

Gennova Biopharmaceuticals
10.2018 - 05.2020

Executive

Gennova Biopharmaceuticals
10.2015 - 03.2018

Officer

Gennova Biopharmaceuticals
10.2013 - 03.2015

Trainee Officer

Gennova Biopharmaceuticals
10.2012 - 03.2013

Trainee

Serum
03.2012 - 08.2024
ADITI LAGHATE