Sagar Nandkumar GadkarPlot No-53, Flat No.501, Sunrise Residency, Sector 18, Kamothe, Near Gokul dairy, Navi

Mumbai, Maharashtra. India – 410209.Email: sagar.gadkar@gmail.com, sagar1608@rediffmail.com

Mobile: +917760147746

Seek challenging role to effectively employ my academics, skill-sets and expertise in emerging field of Biologics manufacturing.

Profile: MSc. Biotechnology from MGM College, Aurangabad. 4 years & 5 month bio-manufacturing experience; EPOFER, VINTOR , ELAXIM,

REDITUX CRESP,Alizumab, Biomab ,Canmab , ReligrastR , RelferonR , RelipoietinTM , MIRelTM , FostiRel ,ChorioRel and AbcixiRel.

Focus areas: o Upstream manufacturing

– Small scale adherent cell culture and bioreactor operations. - Small scale suspension cell culture and large scale bioreactor operations.- Small scale microbial culture and large scale fermenter operations.- Involved in commissioning and qualification of new manufacturing facility

for mammalian cell culture (Upstream processing and downstream processing).

- Involved in cleaning validation and process validation.- Involved in cell banking activities.(WCBs and EPCB preparations)

Work Experience: Gennova Biopharmaceuticals Ltd., Pune, India (July 2011 – Sep 2012)Worked as Production Officer, Mammalian Suite, for manufacturing of mammalian cell culture based biotherapeutic products. Dr. Reddy’s Laboratories Ltd., Bachupally, RR Dist., Andhra Pradesh, India (October 2012-September 2014)Worked as Associate (Senior Executive), Mammalian Suite, for manufacturing of mammalian cell culture based biotherapeutic products.(Therapeutic proteins , Monoclonal antibodies)Biocon Limited., Biocon Park, Jigani Link Road, Bommasandra Industrial Area, Bangalore, Karnataka, India (September 2014- April 2015)Worked as an Executive (Level3), Biosimilars, for manufacturing of monoclonal antibodies mammalian cell culture.Reliance Life Sciences Limited., Navi Mumbai ,Maharashtra, India (May 2015 – till date)Placed as Senior Executive, Biosimilars Manufacturing Plant.

Expertise :Mammalian Cell culture and Microbial culture operations:

Adherent cell Culture, Perfusion based cell culture and Suspension cell culture based aseptic operations using CHO cells.

Small scale and large scale media and feed preparation, sterile filtration. Cell bank operations - WCB and EPCB preparation.(Rituximab,G-CSF,Dabepoetin

alfa, Trastuzumab, Etanercept, Bevacizumab). Sub-culturing and inoculum development using spinner flasks and shake flasks. Sub-culturing, monolayer preparation and inoculum development using Tissue

culture flask, Roller bottles and Cell stack. Operation of adherent cell culture bioreactors in perfusion mode. Operation of suspension cell bioreactor and media preparation vessels. Harvesting and clarification of harvest. SIP,CIP and COP of bioreactors and media preparation vessels. Autoclave validation and operations (load pattern validation and preparation) Wave bioreactor operation for inoculum development. Inoculum development at spinner stage up to 6L and bioreactors at 5L, 60L,

300L,500L stage. Commissioning and Qualification – Methodical, documented process to ensure that

facilities, systems and equipments meet established design requirements. Approximately 40 systems and stand alone equipments are qualified. Involved in cleaning validation and process validation. Internal Auditor for Contractor Safety Management Operation of single use bioreactors (Wave Bioreactors,Hyclone,Rotatory motion

Sartorius – 20/50L, 100/200 L, 500 L) Operation of microbial fermenter 10L, 100L and 1000L (Make: Sartorius and

Biozeen)

Manufacturing and cGMP operations: On-line recording of documents like BPR, Cleaning Records, Reagent Records,

Record sheets, solution preparation records and facility monitoring records required to comply cGMP.

Standard operating procedure preparation, corrective action and preventive action (CAPA) report preparation and implementation.

Involved in contamination investigation. Member of GMP team to carry out facility document maintenance of areas and

equipments and systems.(Kill tank operations, autoclave maintenance, Glassware washer maintenance, Decontamination autoclave maintenance)

Change controls and discrepancy/ deviation closures. SAP operations and closures of batches and documents. Co-ordination with quality assurance, quality control and maintenance groups. Involved in internal and external audit preparation. Inventory maintenance. Preparation of documents like BPR,BMR,MFR,BOM, Investigation reports, Batch

summary protocols, CV and PV reports and protocol, reports for CAPA and CC closures.

Equipments: Operation of equipments like:

o Bioreactors of various sizes (5L, 7.5L, 30L, 40L) (New Brunswick Scientific, Artelis)

o Bioreactors of various sizes (5L, 60L, 300L, 1000L,2000L, 3000L) (Sartorius Stedim, Bioengineering)

o Autoclave –Fedegari, Machine Fabrik, Nat steel,Tuttaner.o Wave Bioreactor (GE)o Hyclone (Thermo) & Rotatory motion bioreactor - Sartorius single use

bioreactor (10L,200L, 500L)o Microbial fermenter (10L and 100L Sartorius, 1000L Biozeen)o Centrifuge Alfa Lavalo Homogenizero Glassware washero Media and Buffer preparation vessels.(100L, 300L, 1000L,2000L) (Pharm

tech and DD Enterprises)o Biosafety cabinet and Laminar air flow unit. (ESCO)o Roller CO2 incubator and CO2 incubator.o Filter integrity testing machine (Sartorius)

Project and training: Commissioned and qualified a new multiproduct mammalian cell culture facility for monoclonal antibody production (Upstream and downstream) in Dr. Reddy’s Laboratories Ltd. Biologics Development Center, Bachupally,R.R District,Qutubullapur, Andhra Pradesh. Pin Code 500090 September 2012 – June 2013 Completed one month in-plant training in Process Development Laboratory at

Biotech Park, Wockhardt Ltd, Aurangabad.o Techniques / Equipments Handled (at Wockhardt Ltd.):

Spectrophotometer HPLC Centrifuge Electrophoresis PCR pH Meter Chromatography (Ion exchange, Size Exclusion, Affinity,

Hydrophobic Interaction, Hydroxy apatite, Reverse phase)

Performed project on Poly-hydroxybutyrate (PHB) Production from different microorganisms (Bacillus megaterium, Aspergillus niger, Azotobacter beijerinckia) during curriculum.

Professional / Academic Achievements: Scored highest marks (stood first) in Organic Chemistry in B.Sc first year.

Rewarded by Dr.Babasaheb Ambedkar Marathwada University and S.B.E.S. College of Science Aurangabad.

Got appreciation (Big pat on the back) in 5 months after joining Dr. Reddy’s for best performance during commissioning and qualification.

Auxiliary activities: Participated In National Conference on Environmental Biotechnology and

Sustainable Biodiversity. 26-27th December 2009.

Strengths: Quick learner & excellent team player with ability to meet deadlines & work under

pressure. Creative and imaginative work in resolving the problems related to process

operations. Ability to work on multiple projects simultaneously. Good Communication Skills. Good Analytical Skills.

Academic Qualification : MSc. Biotechnology

MSc. in Biotechnology 2009-2011

MGM College, Dr. B.A.M.University, Aurangabad, with 58.60% of marks.

Bachelor of Science 2006-2009

S.B.E.S. College of Science, Aurangabad, Dr. B.A.M.University, Aurangabad, in First Class with 73.59% of marks.Higher Secondary School Certificate

2003-2005 Vivekanand College of Science, Maharashtra State Board, Aurangabad, with 55.55% of marks.Secondary School Certificate

1998-2003 M.I.T. High-School, Maharashtra State Board, Aurangabad, with 66.66% of marks.

Personal Information: Father’s Name : Nandkumar Damodhar GadkarMarital Status : MarriedDate of Birth : August 16, 1987Languages known : English, Marathi, HindiNationality : IndianHobbies : Listening to music , photography.

Sagar N. Gadkar