SRIDHAR MANNEM

***, ***** ******** **** ****, Dover DE-19901

E-mail: aca9yy@r.postjobfree.com Cell: 302-***-****

Professional Summary

Experience in

Operational management of laboratories (Instruments, Wet Chemistry and

Biological)

Preparation of equipment and functional standard operating procedures as

per cGLP, cGMP and ICH guidelines

Operation, calibration, troubleshooting, maintenance of GC, HPLC and

other analytical equipment

Development, execution of analytical test methods according to

pharmacopeias, ISO, AOAC and other standards and training of chemists

Performing method development, method validations and method transfers

Analysis of non-routine samples generated in unanticipated situations

Analysis of pathogens in samples using molecular techniques (PCR

methods).

Compliance monitoring of quality systems

Improve product quality by coordinating with R&D and manufacturing

departments for standardization of process parameters

Employment History

Volunteer Research Technician at Delaware State October 2013

University, Dover, DE till date

Lead Technician/Group Leader- Quality Control in October 2011

Synthtrix Pharma labs (India) Pvt. Ltd., Visakhapatnam, April 2013

India

Lead Technician/Group Leader- Quality Control in SV'S May 2007

Remedies Ltd., (ISO 9001:2008, GMP certified company), September 2011

Hyderabad, India

Senior Officer- Quality Control in Anu's Laboratories June 2004

Ltd., (ISO 9001-2000 certified company) Shadnagar, India April 2007

Analyst- Quality Control in Inventaa Chemicals Ltd., (an August 2002

FDA approved company), Nandigama, India May 2004

Analytical Skills Summary

Instrumentation

Installation and validation of new equipment

Calibration and maintenance of equipment

Chromatography- Analysis of samples for assay, related substances,

impurities

and purity by HPLC and GC. Testing for residual solvents and organic

volatile

impurities by GC

High Performance Liquid Chromatographs (HPLC)

Agilent- Model AT 1200Series with EZchrome Elite Soft ware

Shimadzu- Model LC 2010 CHT with LC Solutions Soft ware

Shimadzu- SPD10AVP- Class VP Software

Younglin- Model YL11xx series-Autochrom 3000 series software

Gas Chromatographs (GC)

Agilent- Model AT 7890A Series with EZchrome Elite

Shimadzu Model GC 2010plus with GC Solutions

Shimadzu Model GC 2014 with GC Solutions

Shimadzu GC-17A- Class-VP Software

Perkin Elmer with NPD detector

Spectroscopic methods

Ultra Violet- Visible Spectrophotometers

Shimadzu UV1800- UV Probe 2.34 Software

PerkinElmer- Lambda-25

Fourier Transform Infrared Spectrophotometer

PerkinElmer-Spectrum one

Atomic Absorption Spectrophotometer

PerkinElmer-AAS 600

Others-Auto Titrator, Biological Oxygen Demand Incubators, Stability

chambers, portable heavy metal analyzer (PDV 6000 plus)

Physical and Chemical

Titrimetric assays, water content, residues on ignition, loss on drying

Limit tests for heavy metals, chlorides and sulfates

Bulk density, specific gravity, melting point, solubility and

distillation range

Biological

Standard Microbiological techniques (plating methods and serial dilution

techniques,

calculation of CFU)

Efficacy test of disinfectants

Testing for microbial load in finished products

Testing the presence or absence of pathogens in finished products

Microbial monitoring of air in clean rooms using Millipore Air Tester

Antibiotic sensitivity techniques (qualitative and quantitative)

Validation of sterilization processes (Moist Heat, Dry Heat)

DNA extractions and purifications, PCR techniques

Job Responsibilities

Preparation of equipment and functional standard operating procedures

(SOP) as per cGLP, cGMP and ICH guidelines

Developing standard test methods according to

pharmacopeias(USP/EP/JP/IP), ISO and other standards

Maintaining specifications, sampling instructions, test methods and other

laboratory procedures

Preservation and maintenance of reference standards and working standards

Preparation of stock and working solutions required for analysis

Review the calibration records of analytical equipment

Effective utilization of equipment and minimizing their maintenance cost

Preparation of analytical method validation protocols and execution.

Designing and conducting stability studies to support the shelf life of

existing and new products

Checking of QC, manufacturing and other records for their compliance to

standard operating procedures and batch record instructions

Handling of good manufacturing practice audits by customers (Cipla,

Mylan, Jubilyant, Aurobindo and Hetero) and internal audits

Investigating out of specifications (OOS), non-conformances and

implementation of corrective actions-preventative actions (CAPAs)

Collection and making trend charts of QC and manufacturing data for

periodical review

Ensure that the required initial and continuous training of personnel is

carried out and adapted to work deadlines accordingly

Achievements

Recognized for troubleshooting the R & D process involved with

elimination of impurities during Chlorohexenone manufacturing at Anu's

Laboratories Ltd., during 2006.

Promoted as "Assistant Management Representative" for implementing

Quality Management System to achieve ISO 9001:2000 certification in 2009

and ISO 9001:2008 upgrade in 2010, at SV'S Remedies Ltd., during 2008 to

2011.

Computer skills

Experience with Microsoft Office applications (Word, Excel, Power point

and Outlook)

Data analysis and interpretation of reports for final release

Data entry to Enterprise resource planning (ERP) software and monitoring

of the various functions through ERP

Value profile

Ability to grasp new technologies and apply them in a specific context

Detect the sources of difficulties in a situation and recommend solutions

Logical thinking, good analytical and communication skills

Independent, self- motivated and ability to work as part of a tightly-

knit team

Effective organizational, safety and time- management skills

Strong work ethics and believe in moral values

Education

Graduate degree - M.Sc., (Microbiology) from Vignan 2000-2002

School of PG Studies, Guntur, India, affiliated to

Nagarjuna University, India

Undergraduate degree - B.Sc., (Microbiology, 1997-2000

Biochemistry, Medical Lab Technology) from SVKP & Dr.

KSR A&S College, Penugonda, W.G. Dt. Affiliated to

Andhra University, India

References: Provided upon request

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