Senior cGMP Aseptic Manufacturing Technician

**** ******* ***.

San Diego, Ca. *****

Tel: 619-***-****

**********@*****.***

Robert A. Giroux Jr.

Objective:

To Contribute to the manufacturing and quality aspects of pharmaceutical, biotechnology industry and clinical manufacturing organization by applying my knowledge and skills in a scientific GMP environment.

Qualification:

Experience:

More than 15 years of progressive experience in cGMP of pharmaceutical and clinical manufacturing environment. Working knowledge in Manufacturing aseptic techniques, Sterile filtration, Batch Record Review both for master and executed, Visual inspection, Validation of Manufacturing Equipment and Laboratory Protocol Procedure and Supervising and Training of manufacturing personnel

04 to Present Pacira Pharmaceutical San Diego, Ca.

Senior Manufacturing Technician

Performed of manufacturing batch record review according to GMP procedures.

Performed filling and media preparation using aseptic techniques.

Trained in all phases of personnel gowning required by the area procedures.

Sterile filtration of drug product.

Performs various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations.

Prepares components, media, buffers, and other solutions as needed.

Performs filling of product and visual inspection.

Performed manufacturing retain of final drug product.

Performs manufacturing samples for QC in-process data (Blend uniformity, pH values, Bioburden and endotoxin)

Participated and coordinated with quality assurance department with regards to manufacturing deviation and non-conforming materials

Revised manufacturing SOP and master batch record as needed.

Prepares equipment by performing clean in place (CIP), steam in place (SIP) and clean out of place (COP)

Test filters for filter integrity testing.

Participate on continuous process improvements.

Set-up and operates production equipment that includes sampling and process monitoring using automated machinery.

Performs general housekeeping procedure from daily, weekly, and monthly of controlled area.

Coordinate setup and changeover of manufacturing.

01-2017 to 01/2020 Bioduro (Formex) San Diego, Ca.

Manufacturing Supervisor

Performed manufacturing supervisory review of executed batch record.

Initiated participated and performing production deviations, Non-conformance Event (NCE), CAPA’s that may relate to GMP batch process.

Revised manufacturing master batch records, manufacturing forms, SOP and other related GMP documentation.

Performed, reviewed, and reconcile manufacturing final drug product labels.

Prepared components, media, buffers, and other solutions as needed.

Independently lead execution of manufacturing batch records.

Supervised/performed manufacturing line clearance.

Understand basic troubleshooting methodology of all equipment.

Coordinated setup and changeover of manufacturing equipment.

Participated and collaborated with Quality Assurance in performing annual material retains.

Performed bi-annual audit of manufacturing and laboratory logbooks and equipment.

Coordinated with multiple departments including sales and quality on production deliverables.

Developed scalable processes with improve production and reduced cost for manufacturing systems.

Analyzed data and results and provides conclusions and proposal.

Performed manufacturing review of production clinical labels for drug product.

Assisted in reviewing and completing all documentation in compliance with GMP.

Performed client interaction in assigned project lead production.

Independently trains and supports operators in implementation of new product and manufacturing procedures.

Provided tactical direction and immediate supervisor of operators.

Provided routines updates to clients and management.

11-2014 to 01-2007 Formex

Operator II

Responsible for manufacturing GMP products, following SOP’s and accurate documentation of production batch records. Work with automated and semi-automated equipment. Prepare materials and equipment for production. Support equipment and cleaning validation activities. Review of production batch records. Sampling of incoming raw materials.

Performed formulation and capsule filling of drug product.

Re-containerized approved materials for use in manufacturing operations.

Performed labeling and packaging of finished product.

Cleaning and preparing of components use in capsule filling operation.

Experienced in validation of equipment.

Trained new employee.

Knowledge in cGMP.

05-2014 to 11-2014 Ajinomoto Althea. San Diego, Ca.

Sr. Manufacturing Assistant Fill Finish

Performed various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations.

Schedules manufacturing tasks under cGMP guidelines and under close supervision from manufacturing supervisor.

Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management.

Assist in the research and implementation of new methods and technologies to enhance operations. .

Accurately documents data and writes/reviews batch records under cGMP guidelines.

Operated production equipment and may prepare buffers and media, inspect, label, or box.

Prepared material components for production.

Assists in the development of scalable processes with improved product yield and reduced costs for manufacturing systems.

Performed visual inspection.

Responsible for routine maintenance of production equipment.

Initiated and writes revisions to current GMP/SOP guidelines.

Collected and disposes of lab wastes according to established procedures. Schedules manufacturing tasks under cGMP guidelines and under close supervision from manufacturing supervisor.

03-2010 – 04-2014 Sapphire Energy Inc. San Diego, Ca.

Process Development / Chemical Technician.

Performed routine and experimental tasks related to extraction of oils and byproducts from biomass.

Performed oil extractions daily. Use various extraction tools such as pumps, acid-base chemistry, solvent evaporation, centrifugation etc.

Worked with organic solvents, drying, distillation, filtration, liquid-liquid extractions, etc.

Performed routine analysis such ash and moisture content, gravimetric yield, etc.

Performed laboratory scale experiments for oil refining, bleaching, hydrolysis reactions, deodorization, and vacuum distillation.

Sampled preparation for analysis and bench scale experiments

Maintained laboratory space, supplies and equipment.

11-2009 to 03-2010 Profil Institute. Chula Vista, Ca.

Pharmaceutical Service Technician (Part time)

Filled Syringes with precision and using aseptic technique.

Stayed current with all clinical trial drug preparation schedules.

Implement the overall use of pharmaceutical agents and related materials.

Dispensed medications from pharmacy supply area.

Sanitized all equipment and work areas.

Maintained equipment, including calibration.

Knowledge in cGMP and GCP.

06-2005 to 11-2009 Pharmatek San Diego, Ca.

Manufacturing Lead Technician

Responsible for manufacturing GMP products, following SOP’s and accurate documentation of production batch records. Work with automated and semi-automated equipment. Prepare materials and equipment for production. Support equipment and cleaning validation activities. Review of production batch records. Sampling of incoming raw materials.

Performed formulation and capsule filling of drug product.

Performed particle count of manufacturing suite using Met One.

Re-containerized approved materials for use in manufacturing operations.

Performed labeling and packaging of finished product.

Cleaned and preparing of components use in capsule filling operation.

Experienced in validation of equipment.

Trained new employee.

Knowledge in cGMP.

12-2004 to 06-2006 Cardinal Health San Diego, Ca.

Manufacturing Technician II

Performed filling and media preparation using aseptic techniques.

Sterile filtration of drug product.

Performed basic formulation duties for a variety of lot sizes.

Trained in all phases of personnel gowning required by the area procedures.

Performed capping vials and visual inspection.

Performed Batch record and SOP revisions.

Assisted and trained fellow teammates.

Knowledge in cGMP.

12-2002 to 12-2004 Skyepharma Inc. San Diego, Ca.

Manufacturing Technician

Performed aseptic filling and decant bulk adjustment.

Performed other related duties for validation and manufacturing equipment including AMSCO 3000 autoclave Steris washer.

Performed vial washing using Cozzoli vial washer.

Performed basic formulation duties for variety of lot sizes.

Performed capping vials and visual inspection.

Trained in all phases of personnel gowning required by the area procedures.

Trained in all aspect of cleaning and sterilization.

Knowledge in cGMP.

09-2001 to 12-2002Advanced Tissus Sciences La Jolla, Ca.

Manufacturing Technician II

Performed and assist media change, cell harvesting.

Performed freezing of all finished product.

Performed all incoming inspection of raw materials and samples.

Become the point person of Trancytes and Dermagraph inspections.

Performed all 1st article and bioreactor inspection.

Coordinate to Q.C analytical and Microbiology samples.

Monitor and processed the entire hot item on the back-order board.

09-1999 to 09-2001 Camelback San Diego, Ca.

Quality Assurance R&D (Warranty/Return)

Responsible for developing and maintaining quality system procedures including document control and customer complaint processing.

Responsible for 1st article in process and final inspection report and warranty and returned.

Issuing returned merchandise number to the customers and gathering all the data in the computer for final analysis.

cGMP

Education

International Electronics and Technical Institutes. Manila, Philippines.

Electronic Computer Technician.

San Sebastian College, Manila, Philippines.

Major in Marketing.

Awarded Outstanding Performance Award of the year 2008 Employee of the year (Pharmatek)

CPR Certified by Sharp healthcare CTC

Bioduro ATRI Award employee of the year 2017

Certificate of Completion at Freund Vector, May 2018

Related Skills

Computer Software

Proficient in Windows and Microsoft

Proficient in operating various equipment such as Parr Reactor 500ml, 600ml, 2gallon,Distillation equipment, Syncore, Rotovapor, Fluid air granulator, Globepharma tableting, Keypress tableting, Incapsulator, Vector LDCS Hi-Coater, Manual capsule filler, AL90 Automatic capsule loader, Turbula shaker mixer, Lepel Induction Sealer, Blend Master V- blender, CPT-TD-400 Tablet De-Duster, VK 200 Hardness Tester, Watson Marlow 505xy Robot, Met One Particle Counter, Isotemp Stir/Hot Plate, In-Pack Blister Machine, Watson Marlow Peristaltic Pump, AMSCO and Finn-Aqua autoclave, Despatch oven,TL Bosch filler, Adtech filler, Cozzoli vial washer Multimeter, Steris washer, Capsule profill, In-cap Capsule filler, M&O Perry P1500 capping machine, Penn Tech Rotary vial washer, Gruenberg Depyrogenation Oven,

Sartorius Sartocheck III and Waste disposal of Hazardous materials, Gerteis Roller compactor, Korsch Tablet Press.

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