JMP
Nikita Jain
Process Specialist
Hyderabad,India
Summary
Dedicated Bioprocess professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Knowledgeable about downstream purification of Biologics such as mAbs, Fusion proteins, Bioconjugates, Pegylated proteins, Gene Therapy products and peptides.
Overview
8
8
years of professional experience
7
7
years of post-secondary education
3
3
Languages
Work History
MSAT Process Specialist
Alvotech India
Bangalore, Karnataka
05.2022 - Current
- Responsible for writing scale-up strategy prior to tech transfer of manufacturing process to GMP manufacturing across clinical batches
- Investigate ,identify root cause and identify CAPA for manufacturing deviations
- Involve in lifecycle management of commercialized biosimilar product and support and process changes and regulatory impact
- Create and review SOPs and process description document and transfer technology to the team
Scientist-I
CuraTeQ Biologics, Subsidiary of Aurobindo Pharma
Hyderabad, Telangana
08.2016 - 05.2022
- Responsible for purification, development and optimization of chromatography/filtration/viral inactivation/formulation steps to meet desired product quality requirement.
- Evaluate buffers, resins, chromatography/filtration systems, filtration systems during developmental phases of product lifecycle.
- Hands on experience on AKTA systems, TFF systems, depth filtrations , viral filters etc
- Qualification of SDM, process characterization studies, viral clearance studies, resin life time studies, hold time studies etc
- Involved in planning and execution of process characterization for downstream process steps using JMP software
- Coordinating outsource activities-Filter validation, Leachable study, Viral Validation, Impurity analysis
- Coordinate cross functionally to get the results and other supports from cross functional teams for completing the assigned tasks
- Execution and designing of Viral validation studies for monoclonal antibody process at CRO site (BIORELIANCE UK) and working to GMP standards and authoring the technical reports.
- Involved in protein downstream process scale-up (20L to 1kL) and clinical campaign (1kL) activities
- Documentation: Risk Assessment, IPC/IPT,OOS,OOT, Change control, TTD, Validation Protocol, BPR and other technical documents.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Evaluated and implemented new technologies and laboratory techniques to improve quality and process robustness .
Research Executive
Pfizer Biologics Development Centre
Chennai, Tamil Nadu
11.2015 - 06.2016
- Downstream process development of monoclonal antibodies from clone screening till DS preparation
- Cross Functional Coordination with upstream and Analytics to achieve desired results
- Resin evaluation for chromatography and calculating DBC for the resins.
- Screening and comparing of available viral filters and selecting the best fit for the process
- Authoring technical reports and protocols, and electronic lab notebook data capture for regular experiments (eLN and LIMS)
Associate Engineer
Intas
Ahmedabad, Gujarat
07.2014 - 10.2015
- Involved in protein purification process development using techniques of Chromatography and Filtration unit operations
- Authored process development and process comparability reports
- Performed process scale-down of chromatography steps and evaluated using statistical tools
- Actively participated in purification process steps FMEA (Risk assessment) discussion
- Maintained good documentation and data recording of all the operations
Education
Post Graduate Diploma - Business Analytics and Program management
BITS
01.2020 - 01.2021
M.Tech - Biotechnology
National Institute of Technology
01.2012 - 01.2014
B.Tech - Biotechnology
SPSU
01.2008 - 01.2012
Skills
Chromatography (Ion exchange, Affinity, Hydrophobic interaction, SEC and Reversed phase based protein purification)Protein Refolding, PEGylation, Lyophilization development and optimizationDesign of experiments and statistical data analysis (JMP)Purification system AKTA (Prime, Pure, Explorer, Pilot and Avant) handlingColumn packing (lab scale to 2 litre) and calculation of its performance parametersKnowledge of different resins used in chromatography (Cytiva , MERCK, Pall, AVANTOR,Purolite)Skilled in analytical techniques: UV and Fluorescence Spectrophotometry, SDS-PAGEFiltration techniques (nano filtration, depth and dead end filtration, TFF) and related calculationsScale up and Technology transferR&D, Manufacturing and Regulatory documentation
Managerial Skills
Professionalism
Self-monitoring
Intellectual Curoisty
Team Player
Software
MS Office
Power BI
Timeline
MSAT Process Specialist
Alvotech India
05.2022 - Current
Post Graduate Diploma - Business Analytics and Program management
BITS
01.2020 - 01.2021
Scientist-I
CuraTeQ Biologics, Subsidiary of Aurobindo Pharma
08.2016 - 05.2022
Research Executive
Pfizer Biologics Development Centre
11.2015 - 06.2016
Associate Engineer
Intas
07.2014 - 10.2015
M.Tech - Biotechnology
National Institute of Technology
01.2012 - 01.2014
B.Tech - Biotechnology
SPSU
01.2008 - 01.2012