Production Supervisor

DAVID ESTRADA

*** ****** ******, ****** ****, New Jersey 07302

(H) 201-***-**** (C) 201-***-**** ***********@*******.*** www.linkedin.com/in/david-estrada

PROFESSIONAL SUMMARY

20+ years’ experience in solid dosage and semi-solid products working from lab scale up to clinical production in preparation for transfer to full scale manufacturing. Provide support to R&D product development teams in the operation of Mills, Blender, High Shear Granulators, Tablet Presses Spray Dryers, Blister Fillers, Tube Fillers, Tray and Fluid Bed Dryers in addition to all related ancillary support equipment used in GMP manufacturing facilities. I have worked on numerous special assignments with Process Engineering groups in the scale up and validation of full scale manufacturing process at GSK production facilities throughout North America. I am experienced with electronic inventory management systems and personally prepared Standard Operating Procedures, Batch Records and protocols in addition to Co-author of the U.S. Patent Application for “Dental Composition for Hypersensitive Teeth”.

CORE COMPETENCIES

Bilingual English/Spanish

OE Green Belt Certified

Microsoft Office Proficient

Strong Team Building Skills / Team Player

Trained in cGMP

Experienced Communicator

PROFESSIONAL HISTORY

GlaxoSmithKline – Consumer Healthcare R&D, Global Technical Services Group, Parsippany, New Jersey

Lead Production Operator / Systems Specialist 2007 - Present

Responsible for leading the GMP operations team in manufacturing of early stage development batches and GMP clinical batches for stability trials and regulatory submissions to establish product expiry and market license approvals. Key responsibilities:

Schedule all project activities and staff; ensure ability to complete high priority projects in accordance with timelines, category R&D and functional colleagues support groups e.g. QA, Engineering and Technical Operations.

Collaborate with WREF, Quality, Micro, NPD staff and management to assure all staff is properly trained and all procedures are in line with on-site and corporate SOPs and WIs.

Responsible for ensuring that all batch documentation activities are completed in accordance with SOPs (issuance, review and approval of master batch records, performing QC checks of finished batch records).

Coordinate equipment cleaning validation/verification activities including protocols, visual inspections/equipment swabbing and data entry into laboratory management system.

Experience with QbD/DFM tools such as Six Sigma/DOE. OE (Operational Excellence) – Lean Sigma/OE Advocate training completed. Streamlined workflow within processing rooms in the Pilot Plant to better meet project timelines by implementing a JDI (Just Do It) and 5s initiative.

Production Operator 2001-2007

Performed a variety of support activities in an ISO Certified GMP Pilot Facility and Early Stage Formulation Development Labs to ensure that all equipment is maintained in a state of operational readiness to enable studies to be completed on a timely and compliant basis. Key responsibilities:

Diagnose, troubleshoot and resolve equipment problems in the most expeditious and cost effective manner.

Dispense raw materials and packaging components for experimental and human-use batches through the electronic inventory system.

Execute batch records while maintaining strict adherence to cGMP’s and site SOP’s.

Lab Technician, Oral Therapeutic Care – Research & Technology 1989 – 2001

Performed and supported key activities in the Sensodyne brand from lab scale to trail production run batches alongside Senior Scientist. Key responsibilities:

Assisted in implementing next generation technology of desensitizing toothpaste.

Developed method of preparation for next generation desensitizer utilizing past experience and knowledge of copolymers.

Co-author of the United States Patent Application for the “Dental Composition for Hypersensitive Teeth”.

EDUCATION

Bachelor of Science: Biology New Jersey City University, Jersey City, New Jersey Graduate 2001

Corporate sponsored Lean Sigma Green Belt Training and Certification 2006

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