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Technical Service Scientist Resume Example

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TECHNICAL SERVICE SCIENTIST
Summary

Scientist recognized for an ambition, dedication and resourcefulness with an extensive and varied background in Pharmaceutical Industry. Recognized as a motivating team member, inspiring project leader, innovative thinker and trusted decision maker.

Over Ten years of experience and exceptional knowledge in manufacturing and product development in Pharmaceutical Research & Development and Commercial products like Powder Layering, MUPS, Extruder spheroniazation Palletization and Pellet coating (Bottom spray), Dry/wet granulation (HSMG / Top spray), Bi-layer / Tri layer tablets, Direct compression, Liquids, Dry syrups, Encapsulation (Powder / Pellet ) etc. for regulatory markets like USA, Europe etc.

Skills
  • OSD and Liquid Product Technology transfer for FDA Regulatory filing.
  • Planning and Execution of Scale up, Feasibility, Characteristic batch manufacturing and Commercial Validation batch manufacturing.
  • Preparation, Review and approval of URS , FAT, SAT, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification.
  • Preparation, Review and approval of Batch manufacturing and packaging record, Research study Protocol.
  • Handling of Change control system.
  • Review of product dossier.
  • Validation of New product.
  • Deviation investigation
  • Risk assessment and mitigation.
  • Root cause analysis
  • CAPA
  • Manufacturing Trouble shooting.
  • Continuous process improvement.
  • SAP , Trackwise, DMS, CMS
Experience
Technical Service Scientist | 11/2018 to CurrentEmd Millipore - Jakarta Timur , ID

Presently working as Technical service scientist. Primarily, responsible for Process development (Pellets, Solid Orals/ Oral Liquid dosage forms and Hard gelatin capsule) for regulatory market.

Current job responsibility includes:

Project co-ordination, Evaluation, Execution and subsequent Process development of product pertaining in regulatory markets. Planning and execution of Trial/ Feasibility/ Scale up/ Exhibit/ Pre-commercial and Commercial validation batches for regulatory market. Reviewing Pilot batches data, Master Formulation record, Scale up report, Batch manufacturing Record. Prepare and review of Exhibit/ Commercial batch documents like Process validation protocol, Post validation reports. Handling of Change control, Process deviations, investigation and justification reports.

  • To develop the manufacturing process for new products into the manufacturing facility for Scale up/ Exhibit manufacturing and complete the required Process validation according to cGMP/Regulatory standards.
  • Process design and Optimization on new equipment using scientific tools.
  • Quality risk assessment and Risk mitigation.
  • Process Optimization & Scale-up trials to design optimized process & Assessment of process modifications if required.
  • Execution planning for product launch on time as per management requirement.
  • Prepare documents for Engineering batch, Exhibit batch, Commercial validation batch, Investigation report.
  • Effective communication across cross functional teams for Project Planning and Execution.
  • Review of site transfer dossier and developing site transfer products with/without Alternate vendor development activity and Gap analysis.
  • Technical evaluation of raw material per product requirement and coordinate with purchase department for procurement.
  • Technical evaluation of new equipment requires for product manufacturing.
  • Hands on experience / knowledge on Equipment; Korsch compression machine (Single, Bi & Tri layer compression), Glatt FBP (pellet coating-Bottom spray), Glatt Top spray granulation, solid Capsule filling machine, imprinting machine, High shear mixer, Fluid bed drier, Laser drilling, Ointment machine, Glatt Coaters, Blender, CVC packing machine etc.
  • Hands on different pharmaceutical tools like Track and Trace , SAP, QDOC, DMS and CMS.
Research Scientist | 12/2014 to 11/2018Grifols Inc. - Ocala , FL

Worked as Research Scientist (Process Development laboratory ). Primarily, responsible for Process development [Pellets, Solid/Liquid dosage forms and Dry syrups (antibiotic)] for regulatory market like USA, Europe etc.

Job responsibility includes:

  • Project co-ordination, Evaluation, Execution and subsequent Process development of product pertaining in regulatory markets.
  • Planning and execution of Feasibility/Scale up/Exhibit/Pre-commercial and Commercial validation batches for regulatory market.
  • Reviewing Pilot batches data, Master Formulation record, Scale up report, Batch manufacturing Record.
  • Review of Exhibit/ Commercial batch documents like Process validation protocol, Post validation reports.
  • Handling of Change control, Process deviations, investigation and justification reports.
  • Trouble shooting and process improvement of regulatory products.
  • To develop the manufacturing process for new products into the manufacturing facility for Exhibit/Commercial manufacturing and complete the required Process validation according to cGMP/Regulatory standards.
  • Process design and Optimization on new equipment using scientific tools.
  • Quality risk assessment and Risk mitigation.
  • Process Optimization & Scale-up trials to design optimized process & Assessment of process modifications if required.
  • Manpower Management and Execution planning for product launch on time.
  • Effective communication across cross functional teams for Project Planning and Execution.
  • Review of site transfer dossier and developing site transfer products with/without Alternate vendor development activity and Gap analysis.
  • Hands on experience / knowledge on Equipment; Granurex GXR95(Powder layering), GEA compression machine(MUPS), Glatt FBP(pellet coating-Bottom spray), Extruder-Spheronizer (Palletization), liquid/solid Capsule filling machine, Tablet imprinting machine, RMG, FBD, Roll compactor, Compression machines, Coaters etc.
Production Officer (Supervisor /Shift Leader | 06/2011 to 12/2014Salient Crgt - Lincoln , NE

Worked as Production officer in tablets manufacturing department. Primarily, responsible for production of Exhibit and commercial batch for USA, Europe and other regulatory market.

Job responsibility includes:

  • Planning and execution of Validation and Commercial batches for regulatory market.
  • Preparation, review of batch manufacturing record and batch packaging record.
  • Manpower management (Approx. 40 person/shift).
  • Handling of Change control.
  • Process deviations investigation.
  • Trouble shooting of manufacturing process.
  • Effective communication across team members.
  • Enhancement of Qualitative and Quantitative output as per management requirement.
Production Officer | 12/2009 to 06/2011Unique Pharmaceuticals - City , STATE

Worked as Production officer in tablets manufacturing department. Primarily, responsible for production of Exhibit and commercial batch for USA, Europe and other regulatory market.

Job responsibility includes:

  • Preparation, review of batch manufacturing record and batch packaging record.
  • Manpower management (Approx. 20 person/shift).
  • Trouble shooting of manufacturing process.
  • Enhancement of Qualitative and Quantitative output as per management requirement.
Education and Training
R.G.T.U. - - City | Bachelor of Pharmacy06/2008

Degree Passing Year University/board, RGPV Uni. Bhopal Bachelor of Pharmacy

Accomplishments
  • Training program on Supervisor Essential by AAIM Employer association at Alkem laboratories, Fenton, USA.
  • Tablet compression & FT4 Powder Rheology Hands on demonstration and training at Natoli Scientific, Telford, PA.
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Resume Overview

School Attended

  • R.G.T.U.

Job Titles Held:

  • Technical Service Scientist
  • Research Scientist
  • Production Officer (Supervisor /Shift Leader
  • Production Officer

Degrees

  • R.G.T.U. - City | Bachelor of Pharmacy

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