1. SHIKHA SHARMA
Mobile: +91-7259888335
E-Mail: shikhasharma.leo@gmail.com
To deliver result oriented work and to lead the group through the quality.
CAREER PRÉCIS
 Dynamic Professional with 6.6 years of experience in pharmaceutical and
biologics.
 Handled R&D and quality functions in leading Vaccine Manufacturing Unit.
 Certified in Basic and Advance GMP, cGMP and GLP courses.
 Experience on validation/qualification as per GMP norms.
 Establishment of environmental monitoring program for facility.
 Hands on experience in quality control functions including testing, media and solution
preparations, documentation.
 Handled Quality Systems like Change Controls, Deviations, Incidents, OOS and
CAPA
 Excellent interpersonal, analytical and troubleshooting skills with ability to synthesize
complex information and communicate technical issues with skills in innovative and
practical solutions to difficult problems..
 Establishment of laboratory set up for performing sterile cell culture functions as per
cGMP.
 Competent handling of cell lines like CHO, VERO, HEP 2C and macrophage cell line
J774A1.
 Adept in designing and development of bio analytical assays.
 Expertise in cell banking of mammalian cell lines, bacterial, and yeast cultures.
 Hands on experience in process development of vaccines - Anthrax, HBsAg, Acellular
Pertussis and diphtheria.
 Significant exposure of fermentation, media optimization and primary purification.
 Technology transfer from R&D to Production functions.

2.  Training personnel.
 Competence in executing a wide gamut of functions viz. cell banking, process
development, standardization, validation, quality control testing, data management,
quality control documentation and co-ordination.
SKILL SET
Technical
 cGMP Cell banking (cryopreservation) and Dossier preparation.
 Quality control functions
 Environmental monitoring plan designing and implementation.
 Water sample testing, sterility testing, microbial limit test, growth promotion test,
in process sample testing.
 Media functions (Hold time validation, preparations, sterilization, inventory
maintenance).
 Validation of Autoclave, Incubator, HVAC, Method, Area and cleaning validation,
water validation related to production department and various other validations related
to microbiology laboratory
 Designing, planning and execution of Stability Studies
 Cell Line maintenance - Mammalian Cell Culture (VERO, CHO, Hep 2C and
Macrophage like J774A1 cell lines).
 In vitro cell culture assays
 Macrophage lysis assay for anthrax
 Cytotoxicity assay for acellular pertussis
 Cytotoxicity assay for Diphtheria
 Assay development and validation of
 Passage number
 Seeding concentrations
 Incubations parameters – temperature, time period
 Dilution sets
 cGMP Documentation pertaining to SOP and Reports preparation.
 Technology transfer of bioassays.
 Shake flask and fermentation (5L scale) experiments for media optimization and
fermentation parameter optimization.
 Analytical
 LAL test for endotoxin detection
 SDS PAGE
 Protein estimation by Lowry and Bradford method
 Gas Chromatograph
Functional
 Planning, organizing and executing day to day lab activities pertaining to
Microbiology related functions of quality control department and R&D.

3.  Management of samples received in quality control department for testing.
 Imparting training to personnel.
 Ensuring material availability by inventory maintenance and material procurement.
 Calibrating, operating and maintaining a variety of laboratory equipment.
 Identifying, collecting, processing, analyzing and cataloguing data according to
established protocol, procedures & standards.
 Maintaining and translating knowledge of emerging literature, technology and science
into new and innovative methods.
Computer
 Sigma plot for statistical analysis of bioassays
 SAP for material procurement
 Proficient knowledge in MS-Office
Career Contour
Dec’ 2012 to Aug’2014: Ranbaxy biologics division
Highlights
 Supervised routine activities related to Microbiology, in Quality Control Department
including area monitoring, daily calibrations/verifications and sterilizations cycles.
 Prepared SOPs, validation protocols and validation dossiers.
 Performed Water Monitoring, Sampling, Environmental Monitoring Sampling, testing
and reporting of results.
 In-process Sample testing, Sterility testing (direct inoculation and membrane
filtration) and documentation.
 Dexterously handled Media/solution preparation and sterilization.
 Validated media hold time for different in-house prepared media.
 Coordinated with QA for Validation of Autoclave, Incubator, HVAC, Method, Area
and cleaning validation, water validation related to production department and various
other validations related to microbiology laboratory.

4.  Management of Stability studies of vaccines.
 Sample management of samples for testing in quality control.
Oct’ 2006 to Jun’ 2011: Panacea Biotec Pvt. Ltd.
Highlights
 Established and managed laboratory set up for performing sterile cell culture
functions.
 Successfully standardized the bioassays such as Macrophage lysis assay for biological
activity of recombinant anthrax protective antigen and CHO clustering assay for
Cytotoxicity of pertussis toxoid.
 Efficiently transferred the technology of bioassays from R&D to Production
functions.
 Dexterously handled mammalian cell lines (VERO, CHO, Hep2C and macrophage
like J774A 1).
 Catered to all mammalian cell culture based needs of other departments.
 Prepared cell banks pertaining to mammalian cell lines, yeast and bacterial cultures.
 Installation and qualification of equipment.
 Collaborated with other R&D research groups as a member of interdisciplinary team.
 Efficiently and timely document generation, including writing SOPs supporting
analytical methods, assay validation reports, Quality systems, techniques involved and
instrumentation and bio-analytical.
SCHOLASTICS
P.G.D.B.A in Human Resources from Symbiosis Centre for distance learning, Pune, in 2010.
B.Tech. (Biotechnology) from Punjab Technical University, Jalandhar, in 2006; Secured
79.2%.
PERSONAL DOSSIER
Date of Birth: 12th
Aug, 1985
Marital Status: Married
Current address: Sri Venkat Sai Nilayam (opposite SBI ATM), Shirdi Sai Nagar,
Munnekollala, Marathahalli post, Bangalore - 560037
Permanent Address: House No. 2829, Sector 38 C, Chandigarh, 160036