Mazin Adenwala
Biopharma Characterization & Method development
AHMEDABAD
Summary
To serve in an organization where there is an ample opportunity to learn and obtain a position that will enable me to use my strong skills, educational and research background, and ability to work well with people.
A professional with more than 18 years of experience in Bio pharma / Pharmaceutical Industry. Presently working as Application Scientist at Thermofisher India Ltd. Well versed with protein and peptides analysis and their in depth characterization, bio similarity enabling physiochemical studies, purity/impurity method development and validation. Support for cloning process and product development. In depth knowledge of regulatory guidelines. Excellent interpersonal, communication and organizational skills with proven abilities leading motivated teams towards achieving organizational goals.
Overview
18
18
years of professional experience
2011
2011
years of post-secondary education
Work History
Application Specialist
Thermofisher Scientific India Pvt. Ltd.
10.2021 - Current
- Provided training and support to end-users, ensuring smooth adoption of new technologies.
- Contributed to sales growth by demonstrating product expertise during client presentations and negotiations.
- Mentored junior team members in both technical skills development as well as adherence to company values and best practices.
- Increased customer satisfaction ratings through prompt resolution of technical issues via phone, email, or onsite assistance.
- Collaborated with marketing teams to promote product offerings at industry events, increasing brand visibility and generating leads.
- Performed on-site and in-house bench-scale testing, data analysis, and reports.
Scientist
Enzene Biosciences Ltd
01.2014 - 09.2021
- Hands-on experience with physicochemical characterization of therapeutic proteins, peptides and monoclonal antibodies.
- Responsible for cross-functional team coordination between analytical and upstream process / down stream purification / formulation / other analytical teams / manufacturing.
- Characterization of impurities (due to oxidation, deamidation, fragmentation, aggregation) and degradation studies (temperature, pH, light etc.) of the product.
- Deep knowledge and experience developing analytical methods for drug substance / product for release and stability with in-process quality controls.
- Well versed with validation of analytical methods as per ICH guideline.
- Instrumental in conducting biosimilarity studies, comparative degradation studies.
- Established internal reference standard system as per available guidelines.
- Specialties: HPLC/ UPLC (Reverse phase, Ion exchange, Size exclusion), Peptide mapping, 1D-/SDS-PAGE, IEF and Western Blotting, Capillary electrophoresis (CE-SDS, cIEF), Glycan analysis, N-terminal sequencing, Protein estimation by A280nm and Bradfords, Method development, validation and technology transfer.
- Worked on following Projects: Monoclonal antibody, Proteins, Recombined peptide and synthetic peptides, Characterization and upstream support for process development for perfusion, Day wise glycan analysis, Downstream process development for perfusion continues process, Identification and extensive characterization of trisulfide bond in IgG2, Bio similarity dossier for RCGM and PCS study, Method development and qualification, Dossier for CT application, Analytical method transfer to manufacturing site, Process support for refolding kinetics, Characterization and identification of process related impurities, Analytical support for synthetic peptide team to get highest purity at crude level, Process support for purification of crude peptide to achieve purity and yield, Challenging task of method validation and transfer to manufacturing site with limited time period was successfully achieved.
Sr.Analyst
Cipla Ltd.
01.2007 - 01.2014
- Overseeing method validation for regulatory, force degradation study for assay & related substance.
- Working on assay, dissolution, content uniformity & related substance method validation as per ICH Guidelines.
- Preparing SOP’s and reviewing of SOP’s.
- Analytical Data review.
- Working as QA Officer, for analytical incidence.
Education
M.Sc. -
Vinayaka Mission University
PG Diploma - Analytical Chemistry
M.S.B.T.E
B.Sc. - undefined
Mumbai University
Class 12th - undefined
Maharashtra college
Class 10th - undefined
Diamond Jublee High School
Skills
Knowledge of Computers – Computer Hardware & networking
undefinedInterests
Reading
Riding Bike
Enhancing Knowledge
Knowledge Preview - Instruments Handled
- Thermofisher Orbitrab Tribrid model Eclips.
- Waters HPLC system with waters software.
- Waters LCMS Q-Tof.
- Circular dichroism from Jasco.
- CIEF Beckman coulter.
- HPLC System of AGILENT 1100 & 1200 series, Shimadzu 2010 HTA, Dionex Ultimate 3000 (With Chromeleon & Chemstation Software).
- GC with auto sampler system of Agilent, varain (With Chromeleon & Chemstation Software).
- UV-Visible spectrophotometer, VARIAN CARYWIN -50 &100. also from Shimadzu.
- Dissolution Test Apparatus, Electro tab & Lab India.
- Disintegration Test Apparatus.
- Karl Fischer Apparatus, Metrom.
Disclaimer
I hereby declare that all the details mentioned above are authentic.
Timeline
Application Specialist
Thermofisher Scientific India Pvt. Ltd.
10.2021 - Current
Scientist
Enzene Biosciences Ltd
01.2014 - 09.2021
Sr.Analyst
Cipla Ltd.
01.2007 - 01.2014
PG Diploma - Analytical Chemistry
M.S.B.T.E
B.Sc. - undefined
Mumbai University
Class 12th - undefined
Maharashtra college
Class 10th - undefined
Diamond Jublee High School
M.Sc. -
Vinayaka Mission University
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