Principal Investigator

Carl E. Bates II

*** ******* ****** *******, **. 08869

908-***-**** ****.*********@*****.***

SUMMARY

Experienced bioanalytical Principal Investigator with project management and hands on laboratory and Quality Control expertise. Major strengths include the ability to work independently at a high level, to work effectively in a team environment, and project management. Friendly, approachable, and strong character. Proven ability to provide strong leadership and maintain focus on timelines and project priorities while driving multiple projects for several clients simultaneously. Known for providing quality results performing hands on work at the bench.

PROFESSIONAL EXPERIENCE

Gibraltar Labs, Fairfield, NJ.

Senior Chemist, March 2017 to Present

Senior Chemist

Worked with Chemistry Manager to assist with understanding client needs, updating SOPs, and bringing in new technology.

Ran analysis for heavy metals, nitrates, viscosity testing, bulk density, arsenic, loss on drying, residue on ignition, refractive index, identification, etc.

Assisted in decreasing backlog of Microbiology department for a fungicidal assay, while troubleshooting several assays and bringing in new techniques and knowledge (ie. Repeater pipettes, cleaning steps of glassware, etc.).

Pharmedium (via Regulatory Compliance Associates, Inc.) Dayton, NJ.

Laboratory Technician, February to March 2017

Laboratory Technician

Assayed intravenous bags for Magnesium and Sodium using Atomic Absorption.

Mentored and trained new staff.

Intertek (via Aerotek) San Diego, CA.

Senior Principal Investigator, August 2016 to October 2016

Senior Principal Investigator

Assisted in decreasing backlog (ie. Typed reports, reviewed data, etc.).

Managed laboratory work for bench chemists.

Worked to meet revenue targets.

Assisted in organizing priorities to keep work flow moving and to meet deadlines.

Carl E. Bates II

Covance, Inc. (Previously Tandem Laboratories, LabCorp Clinical Trials) West Trenton, NJ.

Principal Investigator, September 2007 to April 2016

Project Manager, March 2006 to September 2007

Principal Investigator and Project Manager

Managed studies while performing drug discovery, method adaptation / development of new

methods, validation and re-validation of existing methods. and processing production and discovery samples with stable-labeled and radio-labeled compounds, using protein precipitation, liquid/liquid, solid phase, and online extractions for analysis using LC/MS/MS instrumentation following company SOPs and GLP guidance.

Performed general chemistry lab tasks as well as wet chemistry techniques (ie. Solution preparation, sample extractions).

Designed and executed experiments.

Trouble-shot and maintained instrumentation.

Represents the single point of control for research projects.

Compiles and communicates study requirements to appropriate study team members.

Develops Study Plans and ensures that the Plans and report, including any changes, are approved and in compliance with appropriate SOPs, GLPs, quality agreements, and regulatory agency guidelines.

Provides relevant information to assure accuracy of forecast and revenue recognition, reviews.

cost estimates and financial information for accuracy

Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.

Leads efforts with the study team to troubleshoot and solve assay problems, as necessary.

Reviews reports for scientific accuracy and completeness.

Provides technical/scientific guidance and leadership to ensure project completion and to other

areas of the company.

Responsible for ensuring that any unforeseen circumstances that may affect the quality and integrity of the study are identified and documented as they occur and corrective action is taken.

Responds to unscheduled deadlines, client needs, and crises without neglecting other duties.

Co-authors scientific papers/posters which are published or presented at scientific meetings.

Evaluates data to assure regulatory guidelines and scientific expectations are met.

Trains less experienced staff.

Performs other related duties as assigned.

Carl E. Bates II

Huntingdon Life Sciences, Inc., East Millstone, NJ.

Project Manager, January 2005 to March 2006

Research Scientist, January 2004 to January 2005

Sr. Scientist, January 2003 to January 2004

Scientist March 2002 to January 2003

Analyst October 2001 to March 2002

Project Manager and Research Scientist

Managed a team while performing drug discovery, method adaptation / development of new methods, validation and re-validation of existing methods, and processing production samples with stable-labeled and radio-labeled compounds in a GLP environment.

Demonstrated ability to successfully prepare blood, plasma, serum, tissue, and urine samples for

analysis using LC/MS/MS instrumentation following company SOPs and GLP guidance.

Performed analysis of biological samples, using protein precipitation, liquid/liquid, solid phase, and online extractions.

Trouble-shot and maintained instrumentation.

Performed general chemistry lab tasks as well as wet chemistry techniques.

Certified training on Sciex API-3000 and 4000 LC/MS-MS system and Analyst software use.

Used Cohesive Turbulent Flow system for online extractions.

Used Tomtec Quadra 96.

Ensured 100% of generated chromatograms are inspected and verified consistency of drawn baseline, integration parameters, and regression results of injected sequences.

Maintained and performed quality control of raw data and prepared validation and study reports.

Assisted with department forecasting.

Prepared statistical tables to help project the need for growth.

Corresponded with Sponsors on a daily basis.

Trained and mentored personnel on daily activities.

Ordered supplies needed to complete my projects.

Performed work, which was presented at industry meetings.

Carl E. Bates II

Test America, Nashville, TN.

GC/MS Operator/Chemist I, Purgeable Organics Department, November 1999 to

October 2001

GC/MS Operator/Chemist I

At the second largest environmental company in the country, analyzed 100 organic volatile compounds in air, soil, and water matrices with several Mass Spectrophotometer Gas Chromatographs: models #HP5971/5890, 5972/5890, 5973/6890, and 17A/QP5000 Shimadzu, all using capillary columns.

Hewlett-Packard version B software was used on all Hewlett-Packard instruments.

Used a 51 sample Archon and a Tekmar Purge and Trap Concentrator models 3000 and 3100.

Ran analysis following EPA method 624 for surface waters, 8260 for soil and water, and 18 for air matrices.

Troubleshot instrument problems to maintain and repair instruments, which sometimes required

me to correspond with service personnel on technical and software problems.

Trained and mentored new employees.

Involved with performing extractions with soil and liquid samples.

Took pH of samples and checked the solubility of hazardous materials.

Calibrated balances and thermometers.

Periodically had to correspond with client services on notifying any problems, which arose due to insufficient amounts of sample.

Underwent private, state, and federal audits.

Middle Tennessee State University, Murfreesboro, TN.

Research Assistant, January 1999 to July 1999

As a Research Assistant, Aided by American Chemical Society Grant and under supervision of a biochemistry professor, was able to participate in an ongoing research project. Completed a multi-step synthesis reaction, which consisted of isotopic labeling, protection, condensation, and deprotection to build radiolabeled N2-Acetyl Gaunosine. Carried out protein purification on adenosine nucleosidase

from yellow Lupin luteus seeds, which was used to break down the nucleoside. Used HPLC 1090 and spectrophotometer 20 to carry out analysis of results.

Carl E. Bates II

EDUCATION

Graduate of Middle Tennessee State University; Murfreesboro, TN. August 1999

First Major: Obtained a Bachelor of Science in Chemistry

Second Major: Obtained a Bachelor of Science in Biology with a minor in Animal Biology

Graduate Courses: Inorganic Chemistry and Medicinal Chemistry

SKILLS

Numerous years of experience at the bench with wet chemistry and bioanalytical extractions.

Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

Hands-on experience with data processing software (Analyst and MacQuan) and Watson LIMS.

Strong working knowledge of FDA GLP requirements, including 21 CFR Part 11, CLIA, OECD, and GCP.

Reputation for learning quickly, successfully training / mentoring new employees.

Demonstrated ability to work independently and in a group with a strong sense of urgency.

Ability to influence, shape and lead without direct reporting authority.

Strong organizational and time management skills; high attention to detail.

Strong Project Management, communication, presentation skills, as well as scientific problem

solving skills.

Managed numerous animal studies for IND submissions and human clinical studies Phase I-IV for NDA submissions, and GCP environments for numerous Indications (Oncology, HIV/AIDS, etc.).

Can analyze and interpret data.

Knowledgeable in Bioanalytical Analysis and chromatography used in this field.

Validation of instrumentation (Performed validation of Tomtec Quadra 96, including creation of

its SOP) used Tomtec Quadra 3 instrumentation.

Extensive experience with Cohesive Turbulent Flow.

Can troubleshoot and maintain instrumentation.

Successfully executed, in academics, a multi-step synthesis reaction to build a radiolabeled nucleoside.

PUBLICATIONS

Co-author of the following:

“Transition state analysis of adenosine nucleosidase from yellow lupin (Lupin luteus)”. Phytochemistry 67, (2006) 5-12

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