pradeep cv final
TRANSCRIPT
V. Pradeep Kumar
Address:First Gulf Bank 10th Floor, Flat No.1012RAK postDubai, UAE
M +971 56 868 [email protected]
Pradeep Kumar
Dear Sir or Madam
Application for a Biologics drug product manufacturing/ Technology transfer role. I am writing this application because I am interested in applying for a position in biologics drug product manufacturing or technology transfer in your company based on my current experience and technical skills acquired. I would bring my expertise to work for the company. I wish that my experiences and skills will meet the job requirements; I have experience in biologics drug product manufacturing in vials, cartridges, syringes and pen device (different formulation such as protein, peptides and Mabs) also my experience covers in process development and technology transfer of the product. Apart from process background I have extensive exposure to Quality systems for the GMP aspects. During my work experience I had faced many regulatory audits and played a key role for success. Currently I work as an assistant manager responsible for biologics drug product manufacturing unit in cartridge line along with the pen device packaging in UAE. Within a short period of time we had qualified the manufacturing site, transferred the technology for the process and about to initiate the commercial scale. I would apreciate if you would consider my application and request a call for a Skype interview to screen my potential skills for a job opportunity in your company. My Interest, technical skills across different organization is described in the CV. Thank you for your consideration, Sincerely
Pradeep Kumar
Curriculum VitaePradeep Kumar
My objective Looking for a promising and exciting position in Biologics
drug product manufacturing /MSAT role in a company
to support, develop and grow the functions based on the
knowledge and experience acquired.
V. Pradeep Kumar
Address:First Gulf Bank 10th Floor, Flat No.1012RAK postDubai, UAE
M +971 56 868 [email protected]
Date of Birth August 10, 1984 NationalityIndian Marital StatusSingle
ReferencesProvided on request
Curriculum VitaePradeep Kumar
Work Experience
since 2015
Fill & Finish lead for the Insulin drug product manufacturing Julphar Gulf Pharmaceutical Industry Dubai, UAE
– Leading Fill and Finish manufacturing unit for insulin drug product manufacturing (Cartridges/Pen).
– Implementation of cGMP procedures and quality systems across the site.
–Settingupthenewfacilityandensuringthequalificationofarea/equipment is complete as per goals.
– Executing the formulation and batch formula as per the technology transfer plan.
– Training and Audits facing.
– Process improvement/trouble shooting for the drug product manufacturing.
October 2013 to August 2015
Technology TransferHospira Biologics Development Centre, India
– Experience in writing the protocols, reports and executing the variousexperimentswithrespecttotheFillfinishprocessstudies.
– Playing an important role in writing the technology transfer documents,findingthegapsthroughFMEAapproachandconducting the process studies to support the potential drug product technology transfer to manufacturing site.
– Developing the Platform strategy and Scale down model approachforFillandfinishprocess.
– Assisting R&D team in Technology transfer, scale up activities processdevelopmentforfillfinishprocess.
– Presenting the Process data in the group meeting and high-lighting the issues as well development in terms of process.
– Experience in handling the bio-physical characterization equipment’s in RND level.
Continued [
Work Experience
November 2012 to October 2013
Senior Executive in Biologics Fill Finish manufacturingIndia Biocon Ltd., India
The responsibilites in this position were the same as listed below in the previous position.
November 2005 to November 2012
Senior Executive in Biologics Fill Finish and Packaging operationIndia Lupin Ltd., India
– Experience in handling the production equipment’s such as washing,filling,sealingandpackaginginvials,cartridgesandsyringes.
– Experienced in writing Documents such as Mater formula record, Batch Records, Standard operating procedures, Equipment operating procedures, Checklist for the equipments and Instrument related procedures with respect tomanufacturingoperation,Qualificationdocuments.
– Hands-on experience in performing the lab scale, development batches, Process validation, cleaning validation at manufac-turing.
– Exposure on new plant setup, manufacturing layout review, Processflowreview,anddiscussionwiththeclientsfor finalizationofthelayoutsandalsoinvolvedincommissioningactivity for a Fill Finish/Packaging unit division.
–Managing&supervisingthefillfinishlinesforvariousdrugproducts manufacturing in vials, cartridges and PFS.
–InteractingandcoordinatingwithdifferentCMO’sforsmoothrunning of manufacturing of sterile drug products for clinical/non-clinical/commercial.
– Tracking on facility occupancy and area of improvement on productivity in manufacturing area on monthly basis.
– Experience in handling the change control, deviations, root cause analysis for batch failures.
– Providing the Employee training relates to procedures and guidelines prior to start the work in Fill Finish suit.
Continued [
Personal experiences
– Having a blend of experience inbiologicsFillfinishmanu-facturing, tech transfer and Research Development.
– Very potential candidate to manage a team.
– Travelled to Dublin Ireland for a major project discussion where the manufacturing layoutandtheprocessflowlayout of Biocon Malaysia were reviewed with PM group forLayoutfinalizationforanew plant setup.
– Having audited a manu-facturing facility.
– Audit facing and Presentation.
– Participated on the workshop on “Aseptic processing of sterile drug products and its importance”.
– Attended workshop on “Asepticfiltervalidation”
– Received 1st price for presentation skills for Udbhav program in Lupin
Curriculum VitaePradeep Kumar
– Hands on experience in handling and trouble shoot of production scale lyophilizer.
– Involved in the scale-up of lyophilized products.
– Audit compliance/Facing such as USFDA, ANVISA, WHO and other customer audits.
– Handled various formulations such as proteins, enzymes, monoclonal antibody and peptides.
– Review of documents for dossier submission related to manufacturing.
– Presenting on Fill Finish manufacturing occupancy with respect to Product output/Improvement needs on month basis to the senior leadership team.
– Exposure to Microbial downstream manufacturing operation suchasbufferpreparation,Infusionbodies’solubilizationandpurification(AKTApilot,TFFsystem).
Academic Qualifications August 2009 M.Sc., Biochemistry VinayakaMission(AffiliatedtoPeriyarUniversity), Tamilnadu, India
April 2005 B.Sc., Biochemistry VysyacollegeofArtsandScience(Affiliatedto
Periyar University), Salem, Tamilnadu, India
March 2002 Higher Secondary School CSI Higher Secondary School, Salem Tamilnadu, India
March 2000 SSLC-Central Board CBSE, Sri Vidhya Mandir Higher Secondary
School, Salem, Tamilnadu, India
DECLARATION:
I, Pradeep Kumar, declare that the all the above information enclosed is true and correct to the best of my knowledge and nothing has been concealed or distorted.
Yours Sincerely Pradeep Kumar
Languages
Fluent in written and spoken
– English,
– Telugu, Tamil, Kannada and Hindi
About me
– Flexible quick learner and good listener
–Self-confident
– Willingness to accept challenges which can encourage my skills and
knowledge
– I like music, dancing and gym
Curriculum VitaePradeep Kumar
