Jason Breaux

Email: abqoge@r.postjobfree.com

Address: ** ********* **

City: Morgantown

State: WV

Zip: 26508

Country: USA

Phone: 304-***-****

Skill Level: Director

Salary Range: $175,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Jason Carroll Breaux

35 Champagne Drive

Morgantown, WV 26508

Phone: 304-***-****

Email: abqoge@r.postjobfree.com

Experience

Protea Biosciences Group, Inc. 2010-2012

Director, Bioanalytical Services (Test Site Manager)

* Responsible for startup of a new bioanalytical laboratory, including hiring of personnel, writing SOPs, identifying service offerings (both small molecule and large molecule services), procuring instrumentation, and building out of laboratory space

* Responsible for the expansion of bioanalytical services from ~$25,000 to ~ $750,000 in two years, with ~$1,500,000 signed work for the third year. Had full P&L responsibility

* Responsible for the activity of the Quality Assurance Unit and Bioanalytical Laboratory Personnel

* Responsible for interfacing with the FDA and other regulatory agencies

* Responsible for directing the validation of instruments and methods, including those for all large molecules (monoclonal antibodies, vaccines, protein therapeutics, biomarkers, etc.) and for small molecules (pharmaceutical compounds and animal health compounds)

* Oversaw the implementation of product release testing methods, as well as, for in-process testing for various pharmaceutical compounds and ingredients, including both large molecules (monoclonal antibodies, vaccines, protein therapeutics) and small molecules (pharmaceutical compounds and animal health compounds)

* Serve as liaison between Protea Biosciences personnel and clients on all technical, preclinical and clinical testing requiring GxP compliance, as well as non-GxP studies

* Manage in-house technical, preclinical, and clinical testing requiring GxP compliance, as well as non-GxP studies

* Oversee all processes within the Bioanalytical Laboratory, including instrumentation and equipment, ensuring that staff is trained, processes are followed, methods are validated, and equipment is qualified

* Conduct regular operational reviews to assess progress on existing processes, identify and solve problems, and recommend process improvements

* Provide regular updates to business partners/upper management concerning detailed knowledge of local operational issues likely to affect the successful outcome of studies

* Act as an expert for problem solving and GxP

* Facilitate in identifying and developing client services, including new service offerings

* Develop, review and evaluate SOPs, study-specific procedures, and databases

* Anticipate and identify project related issues. Work with the appropriate personnel for issue resolution.

* Identify training needs/learning opportunities and participate in the training and education of company project teams and external customers

* Track and assess study progress, budget, and project team responsibilities

* Work within the regulatory requirements and develop testing strategies acceptable within the regulatory landscape

* Represents CRO at client meetings and industry trade shows

Senior Manager 2010

* Advise the Director of the BAL, Laboratory Manager, Analysts, Laboratory Technicians, and metrologists for work on active BAL projects.

* Lend support to nonclinical development and clinical development programs related to a therapeutic protein

* Assist in the qualification of instrumentation end methods.

* Write and review SOP's, protocols, methods, study plans, and reports for active projects in the BAL.

* Provide advanced training of BAL staff for use of equipment and instrumentation.

* Work with management to identify new opportunities for GLP products and services to be released by the BAL.

Pyxant Labs Inc. 2009-2010

Consultant/Group Leader

* Assisted in improving efficiencies in laboratory

* Assisted with FDA audits and responses

* Responsible for finding and correcting deficiencies in SOPs and laboratory practices

* Responsible for daily laboratory activities, including budgets, keeping laboratory associates on schedule, and keeping clients informed of daily progress

* Responsible for training and supervising chemists in the operation of the instruments, method development, method validation, and sample analysis

* Responsible for writing proposals to clients, validation and sample assay reports, responses to audits (both client and FDA), SOPs, and technical documentation for sales group to distribute to potential clients

* Assisted with the implementation of GMP release testing methods for various pharmaceutical compounds and ingredients

* Responsible for attending national meetings (AAPS, etc) to represent company and discuss our abilities with potential customers

* Responsible for development of new quantitative methods for pharmaceutical drug testing using LC/MS/MS instrumentation

* Responsible for validating and documenting these methods under GLP regulations

* Responsible for operation and maintenance of AB Sciex LC/MS/MS triple quadrapole instruments (2 API 3000's, 1 API 4000, and 1 API 5000), including cleaning, tuning, and calibration

ADMEQuant Bioanalytical Services (formerly Analytical Development Corp.) 2001-2009

LC/MS/MS Manager

* Laboratory Manager for CRO responsible for the startup, organization, and expansion of the LC/MS/MS department from 1 API 3000 to 3 API 3000's, 1 API 4000, and 1 API 4000 QTRAP

* Responsible for the expansion of bioanalytical services from ~$250,000 to over $3,500,000

* Direct and manage daily laboratory activities, including budgets, keeping laboratory associates on schedule, and keeping clients informed of daily progress

* Responsible for training and supervising chemists in the operation of the instruments, method development, method validation, and sample analysis

* Responsible for validation of instruments and methods, including those for large molecules (oligonucleotides, vaccines, etc.) and for small molecules (pharmaceutical compounds and animal health compounds)

* Lead contact for all client relations, including visits and audits

* Lead contact for all FDA GLP audits

* Lead contact for all bioanalytical technical discussions in support of BD personnel

* Responsible for writing proposals to clients, validation and sample assay reports, responses to audits (both client and FDA), SOPs, and technical documentation for BD managers to distribute to potential clients

* Responsible for attending national meetings (AAPS, etc) to represent company and discuss our abilities with potential customers

* Responsible for development of new quantitative methods for pharmaceutical drug testing using LC/MS/MS instrumentation

* Responsible for validating and documenting these methods under GLP regulations

* Responsible for tracking new FDA guidelines for method validation and sample analysis, including all discussions related to ISR, and discussing these with QA in order for them to be implemented in the laboratory

* Responsible for establishing procedures for the efficient analysis of bioanalytical samples

* Responsible for identifying new technology that would aid in increasing efficiency in the laboratory

* Responsible for operation and maintenance of AB Sciex LC/MS/MS triple quadrapole instruments (3 API 3000's, 1 API 4000, and 1 API 4000 QTRAP), including cleaning, tuning, and calibration

* Responsible for troubleshooting any problems with the instruments and methods

* Helped to maintain GC instruments, including various detectors (FID, ECD, MS), and troubleshoot GC methods

Bioassay Laboratory, Inc. 1998-2001

Head LC/MS/MS Research and Development Chemist/Project Manager

* Responsible for the startup, organization, and expansion the LC/MS/MS department of the LC/MS/MS department from 2 API 365's to 2 API 365's and 4 API 3000's

* Responsible for the expansion of bioanalytical services from ~$1,000,000 to over $12,000,000

* Responsible for managing other chemists and aiding them in assay development and validation

* Lead contact for all client relations, including visits and audits

* Lead contact for all FDA GLP audits

* Project Manager responsible for keeping laboratory associates on schedule and keeping clients informed of daily progress

* Responsible for development of new quantitative methods using LC/MS/MS instrumentation

* Responsible for validating and documenting these methods under GLP regulations

* Responsible for establishing procedures for the efficient analysis of bioanalytical samples

* Responsible for identifying new technology that would aid in increasing efficiency in the laboratory

* Responsible for operation and maintenance of PE Sciex LC/MS/MS triple quadrapole instruments (2 API 365's and 4 API 3000's), including cleaning, tuning, and calibration

* Responsible for troubleshooting any problems that occur within all assays

* Knowledge of Analyst software for PC (LC/MS/MS), MassChrom software for Macintosh (LC/MS/MS), and Waters Millenium software for PC (HPLC) for use of assay development, data collection, and data quantitation

* Responsible for development of new quantitative methods for pharmaceutical drug testing using HPLC instrumentation (Waters, Shimadzu)

* Responsible for interpreting and verifying results

* Responsible for keeping written records of all research conducted

Laboratory Corporation of America 1997-1998

Forensic Toxicologist

* Responsible for preparation of samples for screening process

* Perform extraction procedures in order to purify samples

* Perform drug confirmation using Gas Chromatograph/Mass Spectrometer (Hewlett Packard)

* Interpret and certify results according to the chromatographic read out

* Responsible for new method development using GC/MS

* Responsible for following CLIA regulations

Medical Center of Louisiana (Charity Campus) 1996-1997

Clinical Chemistry Laboratory Technician

* Perform routine clinical chemistry tests for hospital patients according to CLIA regulations

* Trained on all chemistry instrumentation routinely used in the Clinical Laboratory, such as HPLC, GC/MS, PCR, and Atomic Absorption

* Trained in CLIA regulations

* Assisted in implementing new procedures in the Laboratory and Hospital for detection of biomarkers indicative of myocardial infarctions

* Trained other personnel in the use of the new instrumentation and procedures

* Conducted experiments and research for Master's Thesis

Education

LSU Medical Center

New Orleans, Louisiana

Master of Science in Pathology, 1997

Concentration in Clinical Chemistry

University of Southwestern Louisiana

Lafayette, Louisiana

Bachelor of Science, Biology-Chemistry, 1994

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