Technical Service Scientist Resume Example Company Name

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 CurrentCompany Name - City, State

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 11/2018Company Name - City, State

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 12/2014Company Name - 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:

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 06/2011Company Name - 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.

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

Technical Service Scientist Resume Example

Resume Score: 80%

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