Scientific Formulation Analytical jobs in Bangalore : Syngene International

[muthukalee]

Sr. Scientific Manager Formulation Analytical R&D (FDC033)

Position :
Sr. Scientific Manager Formulation Analytical R&D (FDC033)

Qualification :
PhD in chemistry or Pharmaceutical/ Analytical chemistry

Experience :
About 10+ years of industrial experience in development of analytical methods for solid and liquid dosage forms

Location : Bangalore

Role :

Formulation Development Center (FDC) is an integral part of Syngene offering formulation and analytical development services for new chemical entities (NCEs), generic molecules and OTC products. The incumbent will be leading analytical R&D team responsible for developing and validating analytical methods for variety of dosage forms, managing method transfer, stability studies , providing scientific and technical oversight and interfacing with clients to ensure seamless collaboration with emphasis on high quality and speed.

Skill Set :

The knowledge of cGMP principles, and US and EU regulatory guidelines is required. The candidate must possess excellent communication and leadership skills and should be an excellent team player.

Apply

About us :
Established in 1994, Syngene was India's first Custom Research Organization to receive special export status by the Government of India. Over the past 15 years, we have successfully partnered leading players in the global pharmaceutical industry across a range of challenging programs, from discovery to supply of complex development compounds.

Contact us :
Syngene International Ltd.
Biocon Park , Plot 2&3,
Bommasandra Industrial Estate - Phase-IV
Bommasandra-Jigani Link Road,
Bangalore 560 099
India
Phone : 91 80 2808 2808
Fax : 91 80 2808 3150
http://www.syngeneintl.com

[Guest]

Respected sir/madam
I have completed M.Sc.biotechnology. I am interested to work in
your organisation.If there is any job opportunity please inform
me. I would surely work up to your expectation and promise to do my
best ...
thank you..
vijaykumar .R

E-mail : vijayraju86 AT gmail.com
Career objective :
Seeking a challenging position to utilize my skills and abilities in the area of Science and Innovation which offers professional growth while being resourceful, innovative and flexible in this competitive corporate world.
Professional Experience :
Designation :Trainee in Pre Clinical Department
Company : Avesthagen Biotech Limited ,ITPL, White Field, Bangalore
Duration : Dec 2009 to Sept 2010
Designation :Specialist resource person
Company :National Afforestation and Ecodevelopment Board
University of agricultural Sciences
Duration : Dec 2008 to Dec 2009
Academic Qualification :
Ms.c BIOTECHNOLOGY Sree Narayana Guru Arts & Science College, -2008 First class
Bharathiar University, Coimbatore
Bs.c BIOCHEMISTRY Shri Nehru Maha Vidyalaya Arts & Science -2006 First class
College, Bharathiar University, Coimbatore
HSC St. Josephs Boys Higher Secondary School -2003 First class
Coonoor. The Nilgiris.
SSLC St. Josephs Boys Higher Secondary School, -2001 First class
Coonoor. The Nilgiris.
Project Details :
“BATERIOPHAGE A THERAPEUTIC AGENT AGAINST STAPHYLOCOCCUS AUREUS”
Technical Skills :
- Plant Tissue Culture
- PCR
- Basic Microbial Techniques
- Isolation of Genomic DNA & RNA
- Electrophoresis
- Isolation of Peripheral Blood Mononuclear Cells
Computer Proficiency :
To work in MS Office Tools (i.e. Word, Excel, PowerPoint, etc.)
.
Behavioral characteristics :
- Commitment to quality and results
- Responsibility
- Sincere in attitude
I do hereby declare that all the details furnished above are true to the best of my knowledge and belief.
Yours faithfully,
VIJAY KUMAR.R

[mihirs_world]

I have total 3.4 years of pure downstream processing experirnce with good knowledge of filters and instruments used like TFF,CENTRIFUGE,CHROMATOGRAPHY(anaion,cation exchanger and hydrophobic interaction).good knowledge of cGMP and maintaing IT.

GO THROUGH MY CV FOR INFORMATION AND LOOKING FORWARD FOR INTERVEIW TO DISSCUSS MORE ON MY EXPERIENCE.

MIHIR PATEL
E-mail : mihirs_world AT yahoo.com
OBJECTIVE :
Perceiving a challenging career in professionally managed, system driven organization to contribute my best
efforts towards the interest of the organization in a position that utilizes my skills while furthering my personal
and professional goals as well as to contribute strong quality skills, expertise and experience in Biotechnology
and develop myself as a valuable asset for the organization.


PROFESSIONAL JOB SUMMARY

Reliance Life Sciences, Navi Mumbai From September 2007 till Date

Currently working in the company’s cGMP PLASMA PROTEINS Manufacturing Facility.


Work Profile in the organization as an Executive

Expertise in carrying out downstream purification process of therapeutic plasma proteins like albumin, IgG, thrombin, fibrinogen, Factor VIII.
Monitoring, Control and troubleshooting of product specific production / process operations.
Preparation of various SOPS based on GDP guidelines.
Finalization of Batch Manufacturing Records, and review of the same.
Actively participated in SAT.

Carried out validation documentation of Autoclave(ctp,IQ,PQ,OQ).

Competent enough in allocating shift responsibilities at par and leading the team by getting it done in required time.
Possess knowhow about all the ICH and other cGMP based guidelines pertaining to manufacturing of Biological drugs.

Successful contribution as a team member in Indian FDA, Domestic and International Client audits such as Egypt Audit and IMB (Irish Medicine Board).
Proper Technical coordination with the Quality and R and D personnel’s in the company.
Effective and competent troubleshooting of critical operative steps during the cGMP manufacturing of API / Bulk drug substances.
Thorough Knowledge of handling of DCS (Distributed Control system By Siemens PCS 7) and connecting instruments like CIP skid, TFF, Pasteurizer.


Apart from the above mentioned core competencies I am able to carry out the following operations effectively and potentially…..
Adherence to Standard operating procedures, product specifications and safety requirements.
Entering as well as reviewal of data in Quality Records, Batch Manufacturing Records and associated checklists.
Product handling for pharma / biogeneric drugs.
Reporting of non conformities and process deviations during product processing and implementation of corrective/preventive action in no time for the same.
Calibration of all Analytical Instruments in production.
Strict adherence to the established procedures and policies of the company pertaining to Quality, Environment, Health and Safety norms.
In Process product sampling, inspection and storage of the same.
Monitoring area cleanliness of defined and classified areas.
Training of Production Personnel’s for process and product handling.
And involved in validation of process in vessels from water trial to media hold in tanks upto validation batches. I have involved in the process development of albumin production from fraction v and ppf paste.

Technical Knowhow

Has technical expertise in packing of following types of protein purificative columns like Q Sepharose (70L)
Operation and maintenance of Tangential Flow Filtration.
Proficient in carrying out Integrity Tests of various types of filters and cassettes like MILLIPAK 100, 60.


Projects Worked Upon

Successfully completed project on “MICROBIAL TECHNIQUES” form JIVAS (Jain Institute Of Vocational Studies) , Bangalore
Successfully completed project on “IMMUNOLOGICAL TECHNIQUES” form JIVAS (Jain Institute Of Vocational Studies) , Bangalore
Successfully completed another project on “RECOMBINANT DNA TECHNOLOGY” from Garden City College, Bangalore.
Successfully completed another project on “PLANT BIOTECHNOLOGY” from Garden City College, Bangalore.

Computer Skills
Precision in working with all the Microsoft Office Tools like MS Word, MS Excel, MS Power Point, etc.

Training undergone
Six Weeks (17th Sep-26th Oct, 2007) Training in “BIOPHARMACEUTICAL PRODUCTION AND ENGINEERING”
at BIOZEEN, Bangalore.

District head of the for the safety monitoring in case of emergency.

Educational Qualifications

Masters in Biotechnology

From Garden City College (Bangalore University), Karnataka with 74% Marks in 2007

Bachelors in Biotechnology

From Garden City College (Bangalore University), Karnataka with 74.5 % Marks in 2005.

[Guest]

CURRICULUM VITAE

Name : Gopal A.S
Email : gopalanalyst AT gmail.com
gopal_analyst AT yahoo.co.in
Objective :
Young, energetic and result oriented professional with 5 years of experience in Drug Discovery; Extended expertise in Bioanalysis (3.3 years), Capable of handling LCMS/MS,HPLC,UV spectrophotometer etc, Calibration of instruments , SOP and study protocol preparation and complains and Data analysis and management : Deep understanding of technology with focus on delivering business solutions; Persuasive communicator with excellent relationship management skills with the ability to relate to people at any level of business and management; Adroit at analyzing the organization requirements; Highly ethical, trustworthy and discreet;
- Skilled Team member providing technical and functional assistance to the team.
- Exceptional communication, analytical & inter personal and problem solving skills.
- Friendly with an upbeat attitude.
- Excellent decision making skills with a positive approach.
- Dedicated and highly ambitious to achieve personal as well as the organizational goals.
- Ability to build new territories and expand opportunities towards the achievement of stated targets.
Work experience
CONNEXIOS LIFE SCIENCE PVT LTD Bangalore (Mar’08 – Present)
Scientist (Reporting to Lead Scientist)
Key Deliverables
- Instrumental in Screening of NCE's by LCMS
- Accountable for Method development by using LCMS for NCE's and known molecules
- Accountable for Metabolite identification by using Met ID , light sight Software,Metabolynx
- Human and rodent S9 stability check for NCE's
- Involved in CYP enzyme inhibition study
- Protein binding assays
- Involved In vitro metabolic, absorption study and Bio-analysis.
- Whole blood sample analysis for NCE’s
- Well worse with Drug extraction from biological matrix samples, viz Protein precipitation, LLE, SPE.
- Familiar with Pharmacokinetic study data analysis with Winnonlin soft ware.
- Accountable for IC50 Drug calculations using Graph prism pad.
REMIDEX PHARMA PVT. LTD Bangalore (Oct’04 – Jun’06)
Production Chemist (Reporting to Production Manager)
Key Deliverables
- Accountable for Tablet Granulation, punching and coating
- Involved in SOP preparation and complains
- Accountable for batch production estimation and reporting to manager.
- BMR review
Qualification
- M. Pharma with specialization in Pharmaceutical Analysis from RGUHS Bangalore in 2008 with 70%
- B. Pharma from RGUHS Bangalore in 2004 with 64%
- D. Pharma from Mandya Drug Control Board in 2000 with 60%
Research undertaken and handling
- Bioanalytical Method Development & Validation using LCMS/MS.
- In-vitro ADME screening-Chemical stability & Metabolic stability of NCE using in S-9 mix (Species comparison), CYP-450 inhibition, & Protein binding assay
- Pharmacokinetic analysis-Matrix effect, Extraction, Identification and Quantification of NCE’s & their metabolites from Biological fluids
- Metabolite identification using Met ID, Light sight soft ware, Metabolynx & Impurity profiling of NCE.
- Calibration of Instruments-LCMSMS, HPLC, UV-Spectroscopy
Training :
- Training on TQD waters LCMS Method development & Metabolite identification at waters, R&D Laboratory, Bangalore. (13-12-2010 to 17-12-2010)
- Training on Q-Trap-4000 / Impurity profiling & Metabolite identification, at Lab India, R&D Laboratory, Gurgaon. (14-05-2008 to 16-05-2008)
- Training on Shimadzu HPLC for known drug analysis at Drug testing laboratory for 4 months (06-09-2007 to 31-01-2008)
- Two Months in house practical training in Remidex Pharma Pvt ltd, Bangalore (Tablet, capsule, liquid orals, QA & QC Departments).
Instrumentation :
Instrument Software Model Make
Q-Trap (QQQ)
Analyst 1.4.5 Q Trap-4000 ABI
LC-MS/MS (Ion-Trap) Chem Station/LC-MSD Trap software LC/MSD Trap XCT Ultra. Agilent
LC-MS/MS Triple quadrupole
Mass lynx TQD Waters
HPLC (Capillary)
Chem station Agilent 1200 Agilent
Analytical HPLC(UFLC)
LC Solution
Spinco CBM-10
SPD-10
CBM-20A Shimadzu
HPTLC
Win Cats software Linomat- 5 Camag
UV-Spectroscopy
UV Probe 2.1 UV-1600 CE Shimadzu
Achievements
- Secured 6th university rank in concerned discipline
- Screening of More than 2000's of NCE's in short duration using LCMS/MS
- Metabolite identification of NCE's using lightsight and metabolynx software.
- Nucleotides like ATP,AMP in cell extract analysis by using LCMS
Thesis
Submitted thesis on “ Development of new analytical methods for the quantitative estimation of CITALOPRAM Hbr as an active pharmaceutical ingredient” during M. Pharma.

[Guest]

JAGARLAMUDI SRINIVASARAO
E-Mail : jagarlamudi.srinivasarao AT gmail.com
Career Focus
Seeking forward to work in a supportive and co-operative environment with opportunities to enrich my knowledge experience and skill in the emerging and challenging pharmaceutical technologies while contributing my best. A chance to be given so that i can prove my mettle in contributing the success path of analytical research driven progress.
Work experience
Scientist III,
United States Pharmacopeia (USP) India Pvt Ltd
Oct 2007 to till Date Overall responsible for developmental plans, maintenance and implementation of GLP practices in analytical development section
Preparation of analytical method development protocols and reports.
Handling analytical methods and issues.
Performing Dissolution profiles of oral dosage forms (Tablets, Capsules, etc.) and dietary supplements.
Analysis of Reference Standards as per USP34/NF29 (Currently used), Pharmacopoeia Forums and also as per Test Protocols.
Monitoring of CSU (Continue Stability USP) Samples of Reference Standards.
Responsible for Preparation and review of SOPs, Protocols, reports etc.,
Responsible for preparing, executing and completing IQ/OQ/PQ of new instruments.
Leads a Team of Scientists in the routine analysis of development samples ranging from Analytical Method issues, Method verification, Mini validations, and Dissolution multimedia studies.
Analyst
Apotex Research Pvt. Ltd
Jun’ 2006 to Oct’ 2007
Making prototypes of new products for physical, chemical and instrumental analysis and evaluating physical & chemical compatibility of drug substances with other ingredients.
Review and approval of validation protocols and reports.
Review and approval of analytical development reports and test procedures.
Review and approval of analytical method transfers
Handling of customer complaints, failure and OOS investigations
Vendor evaluation and development for raw material supplies and contract manufacturing activities.
Participated in all coordination meeting of FR&D and Regulatory departments for status review of future developmental activities and current status of under developmental projects.
Worked with more than 20 projects for analytical development, validation and stability studies to EU and US dossier filing.
Executive
Aurobindo pharma Limited,
Feb’ 2002 to Oct’ 2004

Validation of Analytical test procedure for Related Substances by HPLC and Assay Validations by HPLC as per ICH & USP Guidelines.
Preparation of in process and finished product analytical procedures.
Designing the schedule of calibration for all instruments and carrying out the same.
Implemented cGMP and GLP practices in the laboratory.
Handled sophisticated equipments like HPLC, U.V. Spectrophotometer, K.F. Titrator etc., Designed and developed analytical methods by HPLC for assay and related substances.
Chemist
Sarvotham care Limited,
Aug’ 2000 to Oct’ 2002
Proficient in maintenance, calibration & troubleshooting of analytical equipments, thereby enhancing productivity.
Developing & implementing experimental procedures for carrying out analysis of chemical processes.
Preparing and maintaining documentation such as laboratory notebooks, electronic data collection, etc.
Implementing stringent systems to ensure high quality standards at all the stages of production.
Professional Achievements Participated for successful completion of audit of US FDA (ANDA’s), UK MHRA and WHO cGMP (Geneva)(ARV’s) within a short span 10 months at M/s. Aurobindo Pharma Limited.
Successful in handling of WHO cGMP (Geneva) audit for qualification of ARVs no major observations.
Successfully completed about 20 assigned products the analytical method development and method validations of products for regulatory market to US(ANDA’s) / EU dossier submission purpose of Finished products at Apotex Research Pvt. Ltd
Instruments Expertise Experienced in handling of LC-MS, UPLC,HPLC, DSC, TGA, Sorption analyzer, Dissolution apparatus, ATR-FTIR, ICP-OES, etc.
Academic Credentials

PhD¯- Pharmaceutical Analysis
Nov 2009 to till date Department of Pharmacy,
Acharya Nagarguna University
M.PHARMACY-Pharmacology
Aug 2004-May 2006

Department of Pharmacy,
Annamalai University
B.Pharmacy
Aug 1996- Aug 2000 N.E.T College of Pharmacy
IT Credentials
HDISM Aptech Computer Education
Research Publications
01. 'COMPARATIVE IN VITRO DISSOLUTION ASSESSMENT OF THREE DIFFERENT BRANDS OF LANSOPRAZOLE CAPSULES' Research Journal of Pharmaceutical Dosage Forms and Technology. 3(2) :March-April 2011, 57-65: January-February:2011; J.SrinivasaRao, J.NagaMallika, M.Sri Madhu Sri, G.Raveendra Babu, M.Prasada Rao and C.Gopinath.
02. STABILITY INDICATING LIQUID CHROMATOGRAGHIC METHOD FOR ARIPIPRAZOLE
Asian Journal of analytical chemistry; Asian J. Pharm. Ana. 2011; Vol. 1 : Issue 1, Pg 01-05 Raveendra B.Ganduri, J.Srinivasa Rao, K.Suresh kumar and Jayachandra R.Peddareddigari