Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Responsibilities
Qualified Examinations
Personal Information
Publications
Extracurricular Activities
Disclaimer
Timeline
Generic

Phanikumar Nasika

Hyderabad

Summary

An inquisitive product manager with 12+ years of cumulative experience in business development and scientific expertise on the characterization of mAbs, fusion proteins, insulins, peptides, and small molecules using mass spectrometry. Regulatory data generation, authoring, submission, and handling queries from the regulatory bodies like the US FDA, MHRA, DCGI, and EMA.

Overview

9
9
years of professional experience

Work History

Lead Scientist-Product analytics

Dr Reddys Laboratories
Hyderabad
06.2022 - Current
  • Handling Analytical and characterization activities for early and late-stage development projects
  • Authoring, Reviewing CMC sections of the regulatory CTD document for many Biologics and protein-based therapeutics
  • Mentoring a group of trainees and scientists on protein analytics (Primary
  • HOS and Attributes)

Business development manager

Coriolis pharma and research GmbH
02.2021 - 06.2022
  • Identifying, approaching and fetching new clients for Mass spectrometry-based projects
  • Continuous monitoring of global CRO trends and market opportunities for the MS services and analytical technologies
  • Frequent customer interactions, representing Coriolis analytical mass spec service business in various conferences and workshops
  • Technically assessing the client needs, develop solutions by coordination with the analytical scientists.

Principal scientist

Biocon-Novel Biologics
09.2018 - 01.2021
  • Disulphide linkage analysis using multi enzymatic and fragmentation approaches, Host cell proteomics, Clipping Analysis, ETD based glycopeptide characterization
  • Primarily supporting the discovery biology team (Biocon Bristol myers squibb) by identifying the critical quality attributes in the mAbs and fusion proteins generated through various cell line development strategies
  • Method development, Qualification and technology transfer to internal and external clients
  • Technical report writing, product characterization documentation in multiple IND filings.

Research Associate

Pfizer Biologics development center
11.2017 - 08.2018
  • LCMS based Method development for methionine oxidation estimation of CDR peptides of monoclonal antibodies-providing support to formulation team
  • Analysis of site-specific glycan distribution in glycoprotein based biotherapeutics
  • Characterization and platform method development of rapifluor/2-AB labelled glycan analysis.

Scientist

Dr. Reddys laboratories
09.2014 - 10.2017
  • Intact Mass measurement, subunit protein analysis, peptide mapping analysis, charge variant analysis, complete protein sequencing, Disulphide linkage analysis, and glycosylation site determination of biologics using LCMS/MS
  • Spent media analysis- method development for quantitation of aminoacids, vitamins and hexoses using MRM on triple quadrupole
  • Assisting the upstream process (specifically in clone selection) by characterizing Glycoprotein based Bio-therapeutic impurities using various chromatographic techniques (RP, IEX, SEC& Affinity) combined with mass spectrometry.

Education

M.S.(Pharm) - Natural products

National Institute of Pharmaceutical Education And Research- Kolkata

B.Pharmacy -

April-2010

Skills

  • Mass lynx, Bio-Pharma lynx, UNIFI, Glycoworkbench
  • Protein metrics, Empower, Data analysis, Turbo-mass
  • Biopharma finder, X-calibur, Sequence editor
  • Agilent Mass hunter, Bioconfirm, Chem station, Chromeleon
  • Liquid Chromatography (Separation strategies):
  • HPLC Agilent (1100, 1200)-chem Station
  • HPLC and UPLC (Waters)-Empower
  • NEXERA UHPLC (Shimadzu-Labsolutions)
  • Capillary zone electrophoresis, CiEF, CE-SDS:
  • GC MS/MS & LC MS/MS Triple Quads
  • LC-MS (Bruker's Amazon 3D ion trap ETD, Maxis ii QTOF)
  • MALDI-TOF (Bruker's Rapiflex, Sciex4800 and 5800)
  • Orbitrap XL, Elite and Q exactive (Thermo fisher)
  • Synapt G2Si HDMS, XevoG2XS (Waters)
  • Perkin elmer GC/FID-MS [EI-MS]
  • AB sciex 5600 Q-ToF and many other mass spectrometer
  • SoloVPE
  • Nano drop
  • UV/Vis spectrophotometer

Accomplishments

  • Recognized as a best employee from Leadership team for meeting the deliverables by overcoming the Covid pandemic hurdles (2020).
  • Received best poster award at Dr Reddys laboratories for the poster presented on Cutting edge Mass spectrometry technologies for sequence validation and investigation of Protein sequence variants-2017.
  • Got appreciation from R&D president for timely completion of tasks and timely delivery of characterization reports for successful IND submissions.
  • Trained at Waters, Manchester on Application of ETD in characterization of Isobaric peptides.
  • Trained at Seoul, Sogang university (Mar-2019 to May2019) on HDX-Frips MS (Free radical induced peptide sequencing -tandem mass spectrometry) in Prof. Han Bin Oh's lab.
  • Received best poster award at Dr Reddys laboratories for the poster presented on Analytical and functional characterization of In-process samples for the selection of Top Clone.
  • A Poster presented at '4th NIPER (Rbl) - CDRI Symposium' on 'Identification of molecular markers of narcotic addiction by using high-throughput proteomic approaches.
  • A poster presented at C-CAMP tech conclave 2013-14 on 'Characterization of biologics and biosimilars'.
  • Participated at International carbohydrate symposium 2014 at Indian Institute of Sciences (IIsc) Bangalore.
  • Attended a course on Glycobiology by Prof. Ajit varki, Scientist (University of California, San Diego) at NCBS-Bangalore, India.
  • Participated as a lead demonstrator on 'GCMS and Its applications' to the students and delegates participated at SERB School on Chemical Ecology 2014 held at NCBS, Bangalore.
  • Participated in a course on Laboratory safety, Radiation safety, Chemical safety, and Bio safety organized by IICB- Kolkata.
  • Managed small group of scientists and tech trainees successfully.
  • Received a Gold medal at National Institute of Pharmaceutical Education and Research (NIPER) For overall excellence performance during M.S (Pharm).
  • Received Scholarship from Govt. Of India to pursue M.S (Pharm) at National Institute of Pharmaceutical Education and Research-Kolkata, India.
  • Registered as a Pharmacist under A.P. Pharmacy council.

Additional Responsibilities

  • Equipment maintenance and troubleshooting.
  • Procurement of equipment, consumables, and chemicals.
  • Documentation in accordance to GLP Literature and patent search.

Qualified Examinations

  • Qualified in the GPAT (Graduate Pharmacy Aptitude Test)-2010, Qualified NIPER-JEE 2010 with all India rank 742.
  • Qualified in state level EAMCET Examination 2006.
  • Successfully completed courses 'General Course on Intellectual Property' WIPO in 2012.

Personal Information

Date of Birth: 02/2024

Publications

  • 2021: Appnote: App Note: Charge variant analysis of Cetuximab with ZipChip on Bruker maXis II UHR-QTOF Arpana D, Phanikumar Nasika, Bruker Team, 908 Devices
  • 2023: Novel charge variant characterization due to glycine to arginine transition at Hinge region in Anti-TNF monoclonal antibody (in Press communicated with mAbs Journal) Rakesh KS setty, Phanikumar N, Haribabu A, Rajiv B, Murali Jayraman ACADEMIC ACHIEVEMENTS

Extracurricular Activities

Got First prize in Table tennis in Inter college level competition. Participated in Personality development workshop. Volunteer at old age fund collection.

Disclaimer

I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.

Timeline

Lead Scientist-Product analytics

Dr Reddys Laboratories
06.2022 - Current

Business development manager

Coriolis pharma and research GmbH
02.2021 - 06.2022

Principal scientist

Biocon-Novel Biologics
09.2018 - 01.2021

Research Associate

Pfizer Biologics development center
11.2017 - 08.2018

Scientist

Dr. Reddys laboratories
09.2014 - 10.2017

M.S.(Pharm) - Natural products

National Institute of Pharmaceutical Education And Research- Kolkata

B.Pharmacy -

April-2010
Phanikumar Nasika