Summary
Overview
Work History
Education
Skills
Timeline
Generic
Shanker Ojha

Shanker Ojha

Ottawa,ON

Summary

Enthusiastic Biotechnology professional with in-depth knowledge of bio-pharmaceutical, bio-manufacturing, and drug discovery processes. Capable of establishing and carrying out tests, evaluating data, and interpreting outcomes. Demonstrated track record of success working in cross-functional teams and delivering high-quality results on schedule.

Overview

7
7
years of professional experience

Work History

Bio-manufacturing Specialist (Consultant)

Commercialization of Cancer Immunotherapy
Montreal, QC
09.2022 - Current
  • Determined viable alternatives in aseptic qualifications procedure to gain sustainable and time-effective benefits
  • Acquired in-depth insights and awareness of Cancer Immune- and Alternative to Immunotherapies to understand clinical importance of those therapies and expand company's portfolio in those arenas'
  • Saved time and money and reduced safety incidents through rewriting procedure for cryopreservation of cells through use of risk assessment tools
  • Improved overall process effectiveness by conducting equipment replacement to achieve targeted efficiency for process by means of qualification process.

Data Analyst

Resilience Bio-technologies Inc
Mississauga, ON
03.2022 - 04.2022
  • Quantified and Qualified QC micro-bio data to determine particle count and used MS Excel for process qualification and validation related data-analysis to reduce inefficiencies and variations in process
  • Employed MS Office, Google Duo, and Teams to manage team meetings, SME discussions and trouble-shootings activities
  • Data visualization for analysis and reduction of spore and microbial population in clean-room.

Operation Associate

CCRM
Toronto, ON
09.2021 - 11.2021
  • Gained insights into drugs developed with stem cells for further advancement in handling different diseases to understand company's potential for developing medication in diverse disease portfolio
  • Managed to complete client projects within specified timelines to build trust and ensure timely delivery of operational activities and procedures
  • Established valuable CAPA (Corrective and Preventive Actions) for practical Gowning qualification (GQ)to achieve efficient and timely completion of GQ.

Executive

Syngene-Biocon
Bangalore, Karnataka
04.2019 - 09.2019
  • Managed full scope of daily duties for preparation, revision, and drafting of Batch Process records, SOPs, scale-up technical reports, data integrity, and safety incidents
  • Reviewed manufacturing process and equipment qualification documents
  • Handled upstream process (perfusion-based process) of single-use bioreactors for four batches
  • Got certified for equipment commissioning and testing by ASTM E2500
  • Oversaw four production batches and ensured complete adherence to GMP guidelines and practices
  • Completed client projects for continuous bio-processing of mammalian cell culture.

Executive

DDE Enterprises
Pune, Maharastra
02.2019 - 08.2019
  • Established 20 client requirements for CQV
  • Performed commissioning, qualification, equipment, and process validation duties to address client needs and expectations while following regulatory guidelines of FDA, DCGI, and EMA
  • Documented Specifications for User Requirements and Qualifications for Design, Installation, Operations
  • Performance for 20+ different client projects of bio-pharmaceutical industry portfolios.

Assistant Manager

Dr.Reddy's Laboratories Limited
Hyderabad, ON
06.2016 - 11.2018
  • Streamlined daily operations by allocating duties, evaluating performances, and improving team efficiency
  • Trained 11 staff members and achieved 100+ batches of contamination-free production
  • Achieved four successful completion of audits including national and international audits of regulatory bodies
  • Validated new process along with MSAT team and assisted in technology transfer of process
  • Estimated accessorial charges for preventive maintenance, environmental, utility monitoring, and SOP's revision
  • Resolved and updated incidents through CAPA, troubleshooting, deviations, and reporting safety incidents related to process-related improvements and troubleshooting
  • Handled 40 batches annually for bacterial cell culture and 30 sets per year for mammalian cell culture.

Education

Masters - Bio-process and Biotechnology

McGill University
QC
2021

Bachelor of Technology - Biotechnology

VIT University
India
2016

Skills

  • Process Improvements
  • Regulatory Guidelines & Safety
  • Compliance
  • Cell Cultures (iPSCs, mammalian,
  • Bacterial and T-cells )
  • QbD and Scale-up
  • PMP Certification (ongoing)
  • Softwares - AKTA, Agilent, SCADA,
  • LIMS, cytobank
  • HPLC, LNP
  • R, SAS,SPSS etc
  • Technical Writing
  • Project Management,
  • SAP, MS office
  • Aseptic Techniques
  • Health Canada, FDA,
  • EMA
  • CAPA, deviations and
  • Change control
  • Documentation - GDP
  • And cGMP
  • Flow Cytometry, ELISA,
  • NMR, SDS ,HPLC,
  • Chromatographic techniques -
  • Small and large scale,
  • Bioreactors - 5L - 2KL
  • Lean Six Sigma (Green Belt),
  • Kaizen (Ongoing)
  • EQMS, LIMS, other databases
  • Delta V, DCS and PLC
  • GAMP and Lean
  • Methodologies
  • Qualification and Experiences :
  • Experience with GCMS, LCMS, Ion Chromatography or other techniques is asset
  • MS and BS in biotehnology with 5 years relevant experience in analytical laboratory
  • Analysis, preferably in pharmaceutical environment
  • Excellent documentation and communication skills
  • Excellent problem-solving, planning, and organizational skilled coupled with strong
  • Attention to detail
  • Ability to work independently under minimal supervision
  • Professional & Technical Proficiencies
  • QbD PAT iPSCs Mammalian & Bacterial Cell Cultures ELISA SDS Design of Experiment LMS QMS
  • Flow Cytometry Chromatography ( AKTA) and Bioreactor ( SCADA) Automated and Semi-Automated Process
  • Page 5 5
  • MS Office SAS, R, SAP, Pymol QuickBooks Invoice Generator Outlook Teams Zoom for Project
  • Management & Logistics Python

Timeline

Bio-manufacturing Specialist (Consultant)

Commercialization of Cancer Immunotherapy
09.2022 - Current

Data Analyst

Resilience Bio-technologies Inc
03.2022 - 04.2022

Operation Associate

CCRM
09.2021 - 11.2021

Executive

Syngene-Biocon
04.2019 - 09.2019

Executive

DDE Enterprises
02.2019 - 08.2019

Assistant Manager

Dr.Reddy's Laboratories Limited
06.2016 - 11.2018

Masters - Bio-process and Biotechnology

McGill University

Bachelor of Technology - Biotechnology

VIT University

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Shanker Ojha