Education + Projects Summary
Abstract
Education
I have done my masters in biochemical engineering from UCL (U.K.). At UCL I got an opportunity to work in Advanced Biochemical Engineering Center (ABEC), which involved several pilot scale equipments i.e. High pressure homogenizer, discstack centrifuge, tubular bowl centrifuge etc.
During my Masters I worked on design project for development of MAbs at large scale using CHO cell line. This project was assessed by members from industrial panels, which included George Blewett from Jacobs Engineering & Other leading process engineers from Lilly and Pfizer etc.
The Project included several modules such as design basis, PFDs and Mass balance for the proposed designs calculations, Validation, Environment & H&S as well as process economics.
Work-Experience
– QSV Biologics Ltd.
Interim Project
Manager Role
I was appointed as an Interim Project Manager at QSV, and played this role for about 4 months. I was responsible to work in association with our business development manager on prospective clients to understand their needs and pursue the projects & processes converting them into secured businesses.
This role required me to work in a relatively new area of project management. In a very short time I adapted myself to new environment, work culture, and used my determination to see the projects through. During this period I worked very closely with other departmental managers to ensure that our team understands the deliverables and is ready to take-up the challenges. I was also asked to provide inputs on the project cost and budgeting. In some cases I was responsible to negotiate the contracts with 3rd party vendors and or to subcontract the part of processes.
Upon arrival of our new project manager I was asked to give more emphasis on building the process development lab. During this period I worked with my other colleagues and technicians to set-up the downstream lab and assisted my support for upstream projects.
Design Engineer
QSV has been expanding very rapidly from last two years and as a Biochemcial Engineer, I was provided with an assignment to lead a team of managers participating with external consultants on facility design and expansion project.
As a team lead I worked on literature and facility design survey of existing models to build a new green field facility as well on the requirements to support the expansions. I reviewed PFDs, Equipment flow, People flow, Equipment Sizing and Utility sizing for the new facility along with my other team members. This project helped me to understand the costing, validation requirements, utility requirements, constraints as well as project management aspect by realizing the dependency of critical tasks and timelines.
Current Role
At present my current role is more focused on developing processes. I train technicians on B.Braun, AKTA and Cogent Systems. I work closely with Sr. Scientists to design, plan and execute the experiments. I am very much responsible for all sort of technology transfers, be it internally or externally from or to the clients. I am working on more than 3 projects at time and managing the resources to perform experiments to deliver an optimized process. I continue working on upstream and downstream on the project to project and need basis.
Work-Experience –
Millipore
Process Development
Scientist
My role as a process development scientist was to work very
closely with our clients and assist them in their development process. Active
participation was required from my end to understand the client’s processes.
Based on the information provided by client I was required to perform the
experiments on-site to demonstrate the effectiveness of Millipore’s filtration
and chromatography products. At times I was also involved in trouble shooting,
installation and to provide validation as well as other technical support to
out clients. On occasions, when I was not traveling to client’s site, I was
responsible to perform filter validations in Millipore’s Access Services
Laboratory.
Processes I worked on
Experience in Virus Purification:
Rabbis & Process Flow of virus purification
Experience in Vaccines purification:
Diphtheria & Tuberculosis & Process Flow of vaccine purification
Experience in Antibodies purification:
Rituxan, FAb - AFAIK & Process Flow of Ab purification
Experience in Recombinant purification:
IGF, EGF PRT-201, Vitronectin & Others & Process Flow for purification
Experience in conjugation technology
AFAIK – Urea-Fab
conjugant & Transmid – Diphtheria Toxin – Transferrin conjugant
Scale-up &
Scale-down projects
Experience in
Chromatography Processes
AKTA Air 100 Explorer system
AKTA bioprocess system
Process Scale chromatography system
BPG 200/500 & 100/500 column
Various XK columns
Millipore ISOPAK column
Millipore K-Prime System
Experience in
Filtration Processes
§ NFF Process
Filtration train design using Pmax & Vmax studies
Filter compatibility studies design
SGF validation
IQ/OQ for Filter housings and cartridges
NFP/NFR sizing analysis
Protein Binding studies on scale down models
Scale-up of NFF process up to > 10,000 L
§ TFF Processes
MF/UF/DF process development & Optimization
Scale-down and scale-up studies and protocol design
FAT/SAT/IQ/OQ of TFF systems for GMP manufacturing
CIP & Recovery studies of TFF cassettes
Scale-up of TFF process up to > 500 L
§ Equipments used for various filtration processes
NCSRT – TFF system
Millipore Pellicon 2 Maxi system
Pall/Sartorius System small scale
GE & Cogent M system for TFF and process development
Small scale – membrane chromatography studies
Labscale TFF system
Techniques used
Process Condition
IEX – Anion
IEX – Cation
Affinity – Protein A, Cellufine Sulphate, Ni-Sepharose, IMAC
HIC – (Phenyl, Butyl, Octyl)
SEC – Size Exclusion
RPC – Reverse Phase
Upstream
B Braun Reactors 5 L
Applikon 150 L
Chemap 750 & 75 L
Disc Stack Centrifuge
Large Scale homogenizer
Pilot scale Microfluidizer
Lab Scale Sonifier
Lab Scale Centrifuges
Nova Bioanalyser
YSI 2700 series Biochemistry Analyser
Analox Me-OH Sensors
Corning Spinner Flasks
Tube Fusers
§
Upstream
projects
Yeast Fermentation (Pichia – MetOH induction, Saccharomyces – DO control and auto induction)
Bacterial Fermentation (E.coli – IPTG induction, E.coli – Temperature induction)
Mammalian cells ( CHO-cell line, SP20-cell line)
Conceptual facility design - large scale mammalian & microbial
protein processing.
Developed a spread sheet to simulate the utility requirements, cost planning and suite occupancy.
Bottle necks
Validation, Optimization & Scheduling of the suites
Batch Record Review
for MA projects/campaigns
Professional
Training
IChemE Continuous Learning Modules
Project Management
Problem Solving
Report writing
ASME Bioprocess Seminar
Bioprocess purification process
Trends in Protein Purification