1. 1
Dear,
Sir/Madam,
Re: Application for your perusal/job, I have attached my resume.
Seeking assignment in Pharma domain at middle management level.
I have done MBA from SMU and M. Pharm from BITS, Pilani (Rajasthan). Currently I am working as
Research Scientist (Assistant Manager) at DR, Reddy’s Laboratories, Hyderabad since May 2015. Now, I
have a better understanding and knowledge regarding my field, Resources management, manpower
management and its related research studies.
I certainly believe that my combination of technical work and efficient educational background has
prepared me to be an efficient member of your organization. I look forward to hear a word from you.
Thanking You
Yours Sincerely
Mahesh Kumar Saini
Enclosures:
Resume

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RESUME
MAHESH KUMAR SAINI
Phone: +91 9100943872, 8884111064
Email: mahesh.18ph@gmail.com, mahesh_18ph@yahoo.com
Seeking assignment in Pharma domain at middle management level.
Professional Abridgement:
• An insightful professional offering around 5 Years of experience in Analytical method
development, Analytical method transfer , Analytical Method validation, Routine analysis, Team
management, Weekly work planning, Monthly project review presentation and Coordination with
CFT members.
• Master of Pharmacy from BITS, Pilani and MBA from Sikkim Manipal University.
• Excellent communication, interpersonal, analytical & negotiation skills with strong organizational
and team building abilities.
Sr.
No.
Organization Duration Profile Designation
1
Mylan Laboratory Limited,
Hyderabad, India
July 2011 to Dec 2011
Analytical development
services
Trainee
2
Mylan Laboratory Limited,
Hyderabad, India
Feb 2012 to July 2013
Analytical development
services
Scientist
3
Biocon Research limited,
Bangalore, India
Jul 2013 to May 2015
Biopharmaceutical
Research Analytical
Senior
Scientist
4
Dr. Reddys Laboratory
(IPDO), Hyderabad, India
May 2015 to Till Date
Formulation Analytical
Research & development
Assistant
Manager
Experience Narrative:
Dr. Reddy’s Lab. (IPDO) in Formulation Analytical Research & Development at Hyderabad.
Experience: 1 Year
• Handling of project individually.
• Cracking the problems related to analytical method development on HPLC for RS, Assay,
Dissolution and FTIR.
• Coordination with cross functional teams QC, QA, RA, Bio and other CFT.
• Analytical method development, Partial method validation and method transfer.
• Presenting the project updates in monthly Project review meetings.
• Weekly and daily work planning.
• Performing Support analysis (RS, Assay, BA, BU, UOD and water content) by using HPLC.
• Support analysis by FTIR and GC.
• Online documentation through ELN and review of empower and ELN data.
• Scientific discussion on project with senior technical experts.

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• Resources & manpower management (HPLC, dissolution, columns etc).
• Ensuring the all filing requirements from technical point of view.
• Handling of change control and incidents.
• Performing the XRD and discussion on XRD data with experts.
• Management of working standards, reference standards, impurities, columns.
• To meet the project timelines.
• To follow and ensure the compliance.
Biocon Research limited. in Biopharmaceutical Research Analytical at Bangalore.
Experience: Around 2 Years
• Analytical method development for Solid oral dosage form and Injectables.
• QbD based analytical method optimization.
• Analytical method validation
• Preparation of analytical method DOE protocol, validation protocol, and method transfer protocol.
• Preparation of analytical method development report, validation report, and method transfer report.
• Preparation of Standard operating procedures and Standard test procedures.
• Reviewing of analytical documents, STP, SOP, Validation documents, Development documents,
and routine analysis documents.
• Preparation for external audit and GLP compliance.
• Analysis of stability samples and initial samples of solid dosage form by HPLC, UV-Visible
spectroscopy.
• Water content determination of API and solid dosage forms (Tablet, Capsule etc.).
• Management of working standards and impurities.
• Calibration and operation of analytical balance, and pH meter.
• Preparation of all the proper documentation to comply requirements of QA.
• Performing the dissolutions of solid dosage forms and recording the data.
• Preparation of monthly review meeting presentations.
Mylan Laboratory limited. in Analytical development Services at Hyderabad.
Experience: Around 1 Year 5 Months
• Analytical method development for Solid oral dosage form.
• Analysis of stability samples and initial samples of solid dosage form by HPLC, UV-Visible
spectroscopy.
• Water content determination of API and solid dosage forms (Tablet, Capsule etc.).
Significant highlights:
• Worked and managed in audit of USFDA, MHRA.
• Handled projects for different markets: USA, Europe, and Japan.
Regulatory skill profile:
•• Having good knowledge on preparation of organized and scientifically valid NDA, ANDA, INDA,
MAA, DMF submissions and CTD dossier preparation.
•• Knowledge of cGMP, ICH, GLP guidelines.
•• Knowledge regarding patent filing and patent laws.
Educational Qualifications:

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• MBA from Sikkim Manipal University, 59%, 2013-2015
• M.Pharm, BITS Pilani, Rajasthan, 7.95 CGPA, 2011
• B.Pharm, Gyan Vihar School of Pharmacy, Jaipur, 69.52%, 2009
• Intermediate, Govt. Senior Secondary School, Jaipur, 64.46%, 2004
• Matriculation, Govt. Senior Secondary School, Jaipur, 66.67%, 2002
Technical Knowledge:
Operated and gathered good experience on:
• UPLC-Waters, UHPLC- Agilent
• HPLC-Waters, Agilent
• Worked on Empower, Open lab Software
• Karl Fischer Instrument
• Dissolution apparatus- Distek, Varian, Electrolab, Labindia
• XRD
• Differential scanning calorimetry (DSC)
• UV- Visible Spectrophotometer
• FTIR
• Spectroflourimeter
• Electronic Laboratory Notebook (ELN)
• Systems, applications and products in data processing (SAP)-Change control management.
• Design Expert 9
• Proficient in Windows Operating System and its application software: MS Office
• Other software: ACD Chemsketch, win nonlin.
Awards / Honors / Achievements:
• GPAT 2010: Rank (AIR) obtained: 2115
• GATE 2009 : Percentile obtained: 93.78
• Coordinated programs at college level
• Highest attendance during B.Pharm and M.Pharm
Trainings:
• Undergone full day training on ‘AUDIT FACING’
• Undergone full day training on ‘ASSERTIVE COMMUNICATION’
• Undergone 9 days training on ‘DOE MODULE-1, 2 and 3’
Electives undertaken during M.Pharm:
• Study on advanced topics: Computer Aided Drug Design, Pharmaceutical Administration &
Management, Advance Physical Pharmaceutics, and Clinical Research.
Participation in Extra-Curricular Activities:
• Attended National Service Scheme (NSS) Camp at BITS, Pilani, Rajasthan.
Hobbies:
• Gardening, Playing Cricket, Watching movies
Notice period: 3 Months

5. 5
Personal details:
Date of Birth : 18/02/1986
Languages Known : English, Hindi, Rajasthani
Gender : Male
Marital status : Single
Nationality : Indian
Permanent Address : 786, Borali ki Dhani, Vill & P.O. - Samode, Teh. - Chomu,
Distt. - Jaipur, Rajasthan, Pin Code - 303806.
PROFESSIONAL REFERENCES:
1. Mr. Rahul Sharma
Senior Scientist, Cipla.
Bombay
Mob- 09538035355
Mail Id- rhlsharma40@gmail.com
2. Kilash Pati Panday
Senio scientist, Biocon Research limited
Bangalore, Karnataka
Mob- 09008485669
Mail id-kailashpatipandey20@gmail.com
3. Mr. Sunil Dubey
Assistant Professor
Pharmacy Group
BITS, Pilani
Contact No- 08239703734
Mail id- sunbit2000@gmail.com
DECLARATION:
I hereby declare that the information furnished above is true to the best of my knowledge and I will
contribute my best efforts to a great extent in achieving the objectives of the organization, if an opportunity
is given to serve in.
Date: May 2016 Mahesh Kumar Saini