Quality Control Analyst

Dominic G. Castillo

** ***** ***** ***********, ** 07621 201-***-**** *******@*****.***

Summary: Exceptional skills utilized to provide Quality results in a controlled and regulated environment.

Implementation of Lean Lab Practices Increase throughput

Decrease and maintain optimal cycle time Collaboration in method development

Investigation of NCR Implementations of Change Controls

Work Experience

Celgene Cellular Therapeutics, a Division of Celgene Corporation, Summit NJ

Analytical Research & Development

Senior Associate, 2010-2015

Job Responsibilities

Integral member of an intradepartmental team tasked to validate innovative assays unique to novel cell and tissue-based products. Recognized as a subject matter expert on an internally developed automated cell counting assay.

Performed, analyzed, and presented results on preliminary pre-validation protocols and troubleshooting experiments designed to demonstrate assay specificity, accuracy, precision and robustness.

Development of sensitive cell based, immunological and biochemical assays for novel stem cell, immune-cellular and biologic devices as characterization tools for research/process development or for transfer to quality analytics for GMP testing.

Charged with writing non-conformance reports, change controls, reviewing and revising standard operating procedures, authoring IQOQ documentation, executing and documenting IQOQ performance.

Experienced in small-scale cell culture methods.

Trained and mentored other group members on the performance of newly developed assays used for release testing

Managed inventory of reagents and lab supplies and cryopreserved cell lines for experimentation and development

Prepared sterile media, performed line clearance and sterile preparation of the production suite, performed media transfers and cell passage, participated in cell harvest as well as aseptic gown qualified. Performed batch record review

Wyeth/ Pfizer Pharmaceutical

Quality Control Analyst, 2006-2010

Job Responsibilities

Worked as part of a team to analyze tablets for release and stability test utilizing cGMP

Charged with mineral station and ICP analysis. Responsibilities included maintenance of Perkin Elmer DV5300 Optima ICP, scheduling of sample testing to maintain optimal cycle time

Initiated and authored laboratory procedures, change controls and laboratory investigations (MIR, LIR).

Approved standards and data entry of co-workers to facilitate specimen cycle time

Charged with writing, coordination and periodic review of practice protocols and guidelines

Executed and performed method validation and method transfer protocols

LACES, SAP, TrackWise, CDAS, EMPOWER, WinLab32, GxPharma

Bio-Reference Laboratories

Technical Services/ Infectious Disease Reporting Coordinator, 2002-2006

Established and implemented protocols for the reporting of infectious diseases through various media to the State Department of Health

Compiled test results from all laboratory departments and prepared the necessary data to be reported to the State Department of Health

Reviewed and documented test procedures in order to maintain compliance for licensure in each state

Acted as a liaison among medical technologists, epidemiologists, physicians, and IT personnel. Provided training to entry level employees

Laboratory Experience

Biochemistry: ELISA, UPLC, HPLC, Osmolality/Osmolarity Assays

Cell Biology: FACS, Multiplexed Cell Health /Viability/Metabolism Assays, Mammalian Cell Culture, Immunohistochemistry/Immunocytochemistry

Instruments: Various Plate readers, ViCell, NanoDrop, IR Spectrometry, ICP (Inductively Coupled Plasma) Analysis, Dissolution, Disintegration, Karl Fischer water determination, trained in Gas Chromatography and FACS CantoII,

Education

Angles University Foundation Angeles City, Philippines

Doctor of Medicine awarded May 2001

Saint Anselm College Manchester, New Hampshire

Bachelor of Science in Biology awarded May 1995

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