Quality Control Development
Resume:
Dr. Maheswara Reddy Musirike
Mobile: +91-903*******, +91-974*******
~ E Mail **************@*****.***
~Senior Level Assignments ~
Pharma Analytical Development
CAREER OVERVIEW
A seasoned professional with over 8 years of rich experience in Analytical Development, Method Validation and Team Management.
Presently associated with Apotex, Pharmachem India pvt Ltd, Bangalore. Expertise in method development and validation,
streamlining processes/ procedures to facilitate robust quality control systems during development. Adept in designing quality systems
and implementing quality processes that will enable organization to consistently meet and enhance high quality output. Possess
strong skills in quality design for new products & validation analytical methods as per ICH guidelines. Excellent analytical,
troubleshooting and inter personal skills with proven ability in driving numerous quality enhancement, process improvement and cost
savings initiatives.
Areas of Exposure
Analytical method development: Managing development of analytical methods for various Raw materials, Intermediates, active
Pharma and drug product with various combinations of excipients. Method conversion from HPLC to fast liquid chromatography to
improve productivity and cost saving.
Method validation: Partial validation of developed analytical procedures by HPLC and GC.
Excipients compatibility studies: Compatibility of various excipients with drug substance.
Method verification: Verification of analytical methods and transfer the technology to quality control department.
GTI Screening: Screening of genotoxic impurities in intermediates and drug substances based on the dosage of drug.
Attending DMF queries: To answer DMF queries and preparation of report.
Qualification of impurity reference standards: Qualification of impurity reference standards for raw materials, intermediates, drug
substances and other process related impurities.
Document preparation and review: Preparation and review of STP’s, Specifications, summary report for method development and
method validation and record of analysis and analytical lab reports as per cGMP .
Career Contour
Since November 2007 with Apotex Pharmachem PVT Ltd., R&D center, Bangalore.
Position:
Officer II
Team Members: Nearly 9 persons varying from Research associate to Officer 1 Level.
Reporting to: Team leader AR&D
Accountabilities
Development of analytical methods for Raw materials, Intermediates and drug substances and drug product with different excipients
to ensure the stability of the drug.
Executing HPLC method partial validations for test methods like related substances, assay and residual solvents for active
pharmaceutical ingredients and for intermediates according to ICH guidelines.
Making HPLC and GC method validation protocols and validation reports for various test methods (Related substances, Assay) for
active pharmaceutical ingredients and for intermediates.
1
Conversion of HPLC Method to UPLC Method
Preparing specification, SOPs and relevant documents as well as undertaking analytical method validation and related documents.
Supervising analytical work & documentation as per pharmaceutical industry regulations (CGMP) various regulatory authorities.
Preparing Certificate of Analysis, Working standard profile, Impurity profile, Method of analysis and specifications for Raw materials,
in process controls, Intermediates and API.
Reviewing documents /analytical reports thereby ensuring documentation as per guidelines and preparing Analytical technology
package for the developed processes.
Training of the analytical personnel according to standard operating procedures.
Method transfer to Quality control once method development and partial validation completion with protocol.
Implementation of good laboratory practices in Analytical Research department and carrying out calibration of the instruments
present in Analytical Research.
Genotoxic impurity screening of impurities and its validation.
Attending DMF queries for screening of related activities and its validation.
Compatibility of various excipients with drug substance.
Achievements
Developed and validated methods of related substances and assay Methods for Varenicline tartrate, Fesoteridone fumarate,
Febuxostat, Dabigatran etexilate mesylate and Saxagliptin hydrochloride with various excipients to ensure the stability.
Majority of the in process, raw material and intermediate methods transferred to UPLC for cost effectiveness and to increase the
productivity.
Alternative method suggests where the runtime of HPLC is more than 60 minutes by adopting shorter length column, ID and particle
size.
February’07 – November’07 Jubilant organosys Pvt Ltd., R&D center, Noida.
Position:
Research associate
Team members: 3 People varying from Trainee to Associate level.
Reporting to: Research scientist AR&D
In process support to R&D activities
Analytical method development of raw materials, Intermediates and API
Method conversion to UPLC for shorter runtime and high productivity
Trouble shooting of HPLC
Calibration of HPLC instruments.
July 2005 February 2007 with Hetero Research and development center, Hyderabad
Position:
Analytical chemist
Reporting to: Group leader AR&D
In Process, Raw materials, Intermediates and finished samples for wet analysis
calibrations of Karl fisher titrater, Melting range apparatus
In process HPLC support
GC development for residual solvents, raw materials and intermediates
Validation of GC residual solvents method.
Calibration of GC instruments.
Screening of reagents and impurities by GC.
Instruments Handled
High Performance Liquid chromatography Waters, Agilent and Shimadzu.
Ultra Performance Liquid chromatography Acquity Waters.
Gas chromatography with Head space and manual injector Shimadzu, Agilent, Perkin Elmer.
2
Fourier Infra red spectra Shimadzu, Perkin Elmer.
UV Spectrophotometer Agilent.
Auto Titrators Mettler Toledo, Metrohm.
Particle size analyzer Malvern.
Karl Fischer Titrators Mettler Toledo, Metrohm.
Preparative HPLC [Semi Preparative HPLC] Agilent.
Liquid chromatograph equipped with mass spectroscopy(LCMS)
Software Handled
Empower II software Waters
LC Solutions software Shimadzu
Chemstation software Agilent
Academic credentials
2011 Ph.D., Analytical chemistry from Sri Krishnadevaraya University, Anantapur, A.P,
Thesis Title: Development and validation of new analytical methods for impurity profiling of
Pharmaceutical substances
2005 M.Sc. (Analytical Chemistry) from Sri Krishnadevaraya University, Anantapur, A.P,
2000 B.Sc. (Chemistry, Physics, Zoology) from Sri Krishnadevaraya University, Anantapur, A.P
Workshops/Training attended
1. Participated in national seminar on Recent Developments in In organic and Organic Materials and
Electro organic Synthesis 2010 (RDIOMES 2010) organized by UGC SAP, Department of Chemistry, Sri
Krishnadevaraya University, Feb 26 27 “A Reverse phase UPLC method for the determination of process
th th
related impurities in Riluzole API”.
2. Participated in national seminar on Emerging trends in Electro chemical studies 2011 (ETCS 2011)
organized by UGC SAP, Department of Chemistry, Sri Krishnadevaraya University, March 24 25 for the
th th
research paper “A novel high resolution RP UPLC method for the quantitative determination of Voriconazole
and its related compounds”.
3. Participated in national seminar on Chemistry and global perspectives 2011 (CGP 2011) organized by
UGC SAP, Department of Chemistry, Sri Krishnadevaraya University, October 24 26 for the research
th th
paper “A novel high resolution RP UPLC method for the quantitative determination of Exemestane and its
related compounds”.
4. Participated in national seminar on Modern trends in chemical analysis 2012 (MTCA 2012) organized
by UGC SAP, Department of Chemistry, Sri Krishnadevaraya University, March 28 29 for the research
th th
paper “A reversed phase UPLC method for the determination of process related impurities in Febuxostat API”.
5. Attended for a two days training program on Analytical Challenges in HPLC Method Development
conducted by Agilent technologies at Bangalore.
Manuscripts published/Accepted in peer review journals
1. A novel high resolution RP UPLC method for the quantitative determination of Exemestane and its related
3
Compounds, Journal of Pharmacy Research, 2011, 4(2), 546 548. Maheswara Reddy Musirike1,
K. Hussain Reddy1, Ramkumar Dhandapani2, Useni Reddy Mallu1 and Varaprasad Bobbarala3*.
2. Development and validation of stability indicating ultra performance liquid chromatographic method for
Riluzole, Journal of Pharmacy Research, 2010, 3(5), 1028 1033. Aleem Ahamed1, Krishnamurthy. G1,*. Maheshwer Reddy3, S.
Ramesha2 and H. S. Bhojya Naik2,*, Charitha. J.G3.
3. A comparative study of letrozole for the determination of stability indicating assay method in pharmaceutical
drug substances by UPLC and HPLC, International journal of science innovations and discoveries, 2011, 1(3), 335 343.
Hanumanturayudu K*, Sreeramulu J, Maheswara Reddy M and Useni Reddy M.
4. RP HPLC/ELSD method determination of Topiramate in Pharmaceutical products, International Journal of
Sciences Innovations and Discoveries, 2011, 1 (2), 126 133, Viswanath Reddy Pyreddy, Useni Reddy Mallu, Pingili Sunil
Reddy, K.Hussain Reddy and Maheswara Reddy Musirike.
5. Stability indicating assay method for lansoprazole a comparative study by UPLC and HPLC.
The Experiment. 2013, 7 (1), 372 380, Hanumanturayudu*, Sreeramulu.J, Maheswara Reddy.M
1
1 1
6. Determination of Stability Indicating Assay Method for Capecitabine in Pharmaceutical Drug Substances a comparative study
by UPLC and HPLC, Journal of Pharmacy Research. 2012,5(12),5515-5519 Hanumanturayudu*, Sreeramulu.J,
1 1
Maheswara Reddy.M
1
7. Determination of Stability Indicating Assay Method for Eszopiclone in Pharmaceutical Drug Substances a comparative study
by UPLC and HPLC. International journal of bioassays. 2013,02(03),554-558 Hanumanturayudu*, Sreeramulu.J,
1 1
Maheswara Reddy.M
1
References
1. S.Krishnasamy,Vice President, Kudos chemie Ltd. Chandigarh, India, Mobile:+91-855*******
2. Professor. K. Hussain Reddy, Department of Chemistry, Sri Krishnadevaraya University, Anantapur, A.P, India. Mobile: +91
Personal Dossier
Father: M. Pedda Eswara Reddy
Mother: M. Balathimmakka
Date of Birth: 10 April 1979
th
Marital status: Married
Blood group: B+ve
Permanent address:
Dr. Maheswara Reddy Musirike
H. No: 1 11, Kanalapalli (village), Deebaguntla (Post)
Nandyal (Taluk), Kurnool (Dist),
Andhra Pradesh, India. Pin No: 518502,
4
Linguistic Abilities: English, Telugu and Hindi
Declaration:
I hereby affirm that the statements furnished above are true to the best of my knowledge.
Date: 20/03/13
Place: Bangalore
(M.Maheswara Reddy)
5
Contact this candidate