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C.S.Sahoo FRD Resume


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C.S.Sahoo FRD Resume

  1. 1. CHANDRA SEKHAR SAHOO Address: Room : F-302,Greenscape Royal,Plot-25,Sector-7,Kamothe,Navi Mumbai-410209 Contact: 09930458239. E-mail: FORMULATION RESEARCH & DEVELOPMENT PROFESSIONALFORMULATION RESEARCH & DEVELOPMENT PROFESSIONAL Seeking challenging assignments acrossSeeking challenging assignments across ANDA formulations, with an organization of reputeANDA formulations, with an organization of repute PROFFESSIONAL SUMMARYPROFFESSIONAL SUMMARY  6 years 7 months + experience in Formulation Research and Development.  Responsible for development of generic solid oral dosage forms (tablets, capsules) for US (ANDA) and European markets.  Experience in handling various dosage forms like IR tablets, pellets, extended release & Osmotic drug delivery.  Experience in robust formulation development, scale-up, manufacturing, trouble shooting and exhibit batches of generic formulations.  Skilled in developing both infringing, non-infringing, stable, scalable and bioequivalent formulations to the highly regulated markets. PROFFESSIONAL EXPERIENCEPROFFESSIONAL EXPERIENCE  Working as Research Officer in Formulation R&D, Generics (Regulated Markets), Glenmark Pharmaceuticals, Mumbai, since Dec 2014 to till date.  Worked as Research Associate-II in Formulation R&D, Generics (Regulated Markets), Hetero Labs Limited, Hyderabad, since May 2011 to Dec 2014.  Worked as Jr. Executive in Formulation R&D of Zenon Labs, Hyderabad, since Oct 2009 to May 2011. PROFESSIONAL CHRONICLEPROFESSIONAL CHRONICLE • Development of solid oral dosage forms like Tablets and Capsules (Modified released and Immediate released). • Adequate knowledge on Literature search including Patent search and good interpretation of patent claims. • Active pharmaceutical ingredient source identification and physicochemical evaluation. • Innovator product identification, procurement and characterization. • Preformulation Studies: Compatibility studies, Hygroscopicity, Forced Degradation, Particle size analysis, Solubility studies etc. • Stability study data generation as per regulatory requirements. • Impurity profiling and setting the specification for developed formulations as per current guidelines along with relevant justification for such specifications set.
  2. 2. • Strong basics in formulation development activities like: Prototype development to designing of final formula, Process Optimization of the formula, Stability study evaluation, execution of Scale-up and Exhibit Batches. • Ability to work in a team and individually to meet the organization requirements. • Co-ordination with Regulatory, Analytical and Production departments during the execution of Exhibit batches • Identification of discriminatory and bio relevant dissolution media for prediction of pharmacokinetic behaviour of the drug. • Sound experience in trouble shooting during scale-up studies and production batches. • Working in close association with Intellectual Property Management Group (IPMG) to finalize non-infringing product development strategies. • Prepared Risk assessment and optimization of formulations using Quality by Design approach. • Responsible for the execution of target projects by utilizing optimum resources within stipulated time • Prepared documents like Product Development Report (PDR), Master Formula Record (MFR), Process Optimization Report and Stability Study Report etc. • Answering the queries on filed projects for different regulatory agencies like FDA, EMEA etc., and meeting their requirements for the acceptance. • Good knowledge about various regulatory guidelines, conducting internal audits in the organization as a part of regulatory compliance. • Regular updating on regulatory guidelines, new technologies in formulation and scientific articles. PROJECT HANDELEDPROJECT HANDELED • Developing immediate release tablet of drug for erectile dysfunction (Para-IV ANDA). • Developing Extended release tablet of anti anginal drug for USA Market. • Successfully developed and executed simple and cost effective bioequivalent formulation of poorly soluble anti retroviral Drugs (Extended release Tablets) for USA and Europe Markets. • Successfully developed and filed PARA-IV ANDA application of poorly soluble anti hyperlipidaemic drug for US market. • Developed extended release formulations for antidiabatic drugs using osmotic drug delivery technology. • Developed extended release capsule dosage forms using pellets for USA Market. • Associated with other projects with my colleagues.
  3. 3. TECHNICAL EXPERIENCETECHNICAL EXPERIENCE • Knowledge in theoretical aspects and handling of coaters (Bectochem, Neocoater, Gansons), Rapid Mixer Granulators, Fluid bed processors (GPCG 1.1,FBE-5), FBD etc. • Experienced in handling of Double rotary Bi-layer compression machine (Cadmach,Eliga press and Sejong ). • Experienced in handling of various mills, capsule filling machines and blenders. ACADEMIC BACKGROUNDACADEMIC BACKGROUND:: COMPUTER KNOWLEDGE AND RELATED SKILLS:COMPUTER KNOWLEDGE AND RELATED SKILLS: • Proficient in use of computer systems under Windows Operating Systems and information retrieval from Internet. SEMINARS/CONFERENCES/TRAINING ATTENDED:SEMINARS/CONFERENCES/TRAINING ATTENDED: • Attended 57th Indian Pharmaceutical Congress, 2nd-4th Dec 2005, Hyderabad. • One month of Industrial Training at Dr Reddy’s Lab, Hyderabad. PERSONAL INFORMATIONPERSONAL INFORMATION Name : Chandra Sekhar Sahoo Date of Birth : 14th May 1982 Sex : Male Marital status : Married Language Known : English, Hindi and Odia Nationality : Indian Permanent Address : S/o- Mr. Bauribandhu Sahoo. At- Red cross road Dist- Puri,Odisha. Passport : Ready I hereby declare that the above mentioned information is true at best of my knowledge. Chandra Sekhar Sahoo 2009 : Master in Pharmacy – Specialization in PHARMACEUTICS with 81.10% University Dept of Pharmaceutical Sciences Utkal University, Bhubaneswar, Orissa. 2007 : Bachelor in Pharmacy with 76.24% University Dept of Pharmaceutical Sciences Utkal University, Bhubaneswar, Orissa.