CHARLES ALBERT PACHECO

**** ******* **. *****: C: 970-***-****

Loveland, CO 80537 E-mail: adbqee@r.postjobfree.com

SUMMARY

CMC professional with over 20 years experience in research, development, manufacturing, and the regulatory requirements involved with drug product development who has worked in start-up, evolving, and established companies. A self-motivated worker who embraces innovation, visualizing and solving problems, process details, and communication.

Analytical Chemist

Stability Exp.

Auditor Experience

GLP/cGMP exp.

IND writer (Stability)

SOP writer

Multi Drug Delivery

Method Transfer

IQ/OQ/PQ experience

PROFESSIONAL EXPERIENCE

Tolmar Inc., R&D and Commercial drug product manufacturer 2013-12/2019

Quality Control Chemist III – Stability and Dermatological Groups (2013-12/2019)

Primary responsibilities include performing testing on creams, ointments, gels, solutions, liquids, and injectables, with a primary emphasis on stability using HPLC, GC, and USP-NF testing techniques. Secondary duties emphasis on bulk and cleaning samples and raw materials release testing to support manufacturing.

Senior Analyst tasked to help schedule work, train Analysts, perform advance tests

Array BioPharma Inc., Drug discovery and development company 2005-2013

Associate Scientist, Analytical – QC (2008-2013)

In addition to Research Associate III responsibilities, continued the development of drug candidates by working with QA, Process Chemistry, and Analytical R&D to deliver clinical products. Systems manger responsibilities included control of operation, maintenance, budget and vendor contact. CMC QC team lead on assigned projects, Regulatory Team CTD CMC/Quality Section author and reviewer, batch record reviewer, assisted method development and transfer. Managed onsite regulated environmental chambers, onsite non-regulated environmental chambers, REES environmental monitoring system, pharmaceutical water system, GE Sievers 900 Laboratory TOC with auto-sampler, Distek dissolution system, conductivity meter. Performed evaluation and process validation (IQ/OQ/PQ) of new equipment: GE Sievers 900 Laboratory TOC auto-sampler with automated data transfer to computer server, 30 2 C / 65% RH Environmental Chamber with regulated monitoring equipment

As senior department member helped maintain QC lab with decreased resources by assuming control and maintaining regulated systems per GMP requirements and assisting junior members as necessary.

QC lead on orphan drug development from Phase 1 to Phase 3, cancer drug through Phase 1 and 2.

Continued to expand drug stability program by managing installation of Intermediate, 30 2 C / 65% RH environmental chamber and assumed control of research chambers operation and maintenance.

Assumed control of pharmaceutical water system and lowered testing costs by 75% and improved testing efficiency by over 50% reduction in time by evaluating necessary tests and re-negotiating contracts.

Primary investigator on 1 drug impurity aberrant result (In spec high impurity), 2 water system OOS results (High TOC, conductivity), 3 equipment failures (MCT, GMP and Research Environmental Chamber) finding and correcting root causes.

Research Associate III, Analytical – QC (2005-2008)

Continued growth of Array BioPharma from contract research organization to pharmaceutical R&D company by establishing a regulated GMP QC laboratory and developing early stage drug candidates. Performed analytical testing under research, GLP, and GMP conditions, including multiple HPLC systems (Reverse Phase, Normal Phase), Karl Fischer analysis (titrant, coulometric, Stromboli oven), thin layer chromatography, UV-visible and FT-IR spectroscopy; dissolution testing, disintegration testing, hardness testing (manual), flame testing, gas chromatography and total organic compound testing (TOC) of Clinical trial dose analysis and reporting, in-process and final release of clinical API’s, cGMP stability studies protocol initiation and execution, raw materials release. Evaluation and process validation (IQ/OQ/PQ) of new equipment: REES environmental monitoring System, GE Sievers 900 Laboratory TOC, 25 2 C / 60% RH and 40 2 C / 75% RH environmental Chamber, Distek on-line dissolution system. Audit team member with over 8 onsite visits evaluating outsource vendors. Spill Response Team member.

Managed installation and expansion of GMP monitoring system from concept to installation including vendor screening, on-site presentations, project coordinator, IQ/OQ/PQ, and maintenance plan.

Oral Presentation, 50th Rocky Mountain Conference on Analytical Chemistry.

Facilitated group learning by sponsoring arranged seminars with invited speakers: Karl Fisher Technology: Doug Clark; Cleaning Validation Strategies, Practices, and PAT: Ronald Burke; TOC and Cleaning Validation: Jonathan Yourkin

Student Intern Sponsor, (2007, 2008 )Array BioPharma Inc. summer intern program.

Sandoz Inc./Geneva Pharmaceuticals, Generic drug product manufacturer 2003-2005

Quality Control Chemist (2003-2005)

Performed testing on over 150 pharmaceutical drug product lines. Testing followed rigorous cGMP protocols of manufactured release lots, stability studies, process validation for new product lines and process improvements of approved products. Investigator of out of spec./irregular results that occurred during testing: Extensive experience with a variety of analytical techniques under GMP conditions, including multiple HPLC systems, Karl Fischer analysis (titrant), thin layer chromatography, UV-visible and FT-IR spectroscopy (pellet and plate techniques), dissolution testing (manual pulls), disintegration testing, and hardness testing (automated).

Complete testing minimum 2 lots per week with ancillary duties to maintain manufacturing schedule.

Invenux Incorporated, Drug discovery biotech company 2000-2003

Associate Scientist (2000-2003)

Established organic synthetic laboratory for startup company by creating organic laboratory space. Ordered equipment, supplies and chemicals, configuring experimental lab space, and performed multi-step organic synthesis and analysis of chemical entities: Drug precursor and combinatorial library synthesis, purification, characterization, modified oligonucleotide synthesis using ABI 392/4 DNA Synthesizer. Multi-step synthesis of organic compounds “bench top” scale, modified oligonucleotide synthesis, experience in drybox and Schlenk techniques. Purification of materials using flash and ion exchange column chromatography, filtrations, dual solvent re-crystallizations, aqueous phase extractions, vacuum distillations, and centrifugal separations.

Assisted with a team of 4 scientists in starting research laboratory from ground up by ordering chemicals, equipment, and configuring bench-top laboratory.

Performed multiple diazomethane syntheses to expedite project completion.

Schweizerhall Development Company, CRO/CMO Process development company 1998-2000

Analytical Chemist, Quality Control (2000)

Performed raw materials release, in-process and release testing of finished products for contracted drug product campaigns: GMP protocols, method development, in process analysis of samples and raw material releases. Extensive experience with a variety of analytical techniques under GMP and research conditions, including multiple HPLC systems, Karl Fischer analysis, gas chromatography, multi-nuclear NMR spectroscopy, thin layer chromatography, UV-visible and FT-IR spectroscopy.

Performed testing of raw materials, in-process, and release samples for multiple drug campaigns.

Helped develop analytical test methods, method transfers.

Advised on testing of manufactured drugs.

Pilot Plant Chemist (1998-2000)

As GMP pharmaceutical pilot plant chemist helped in plant construction, qualification, and performed multi-step synthesis and technical transfers of organic compound methods incorporating step up process chemistry from the “bench top” to the Pilot Plant 50 - 100 gal scale to the commercial scale.

Managed and assisted in construction of pilot plant by reviewing and troubleshooting plant design.

Performed synthesis of first batch in pilot plant and multi-stage GMP drug campaigns.

Performed “first time” pilot plant scale hydrogenations and catalytic reactions.

EDUCATION

B.S. major Chemistry/minor Applied Mathematics, 1997 University of New Mexico, Albuquerque, NM

ADDENDUM

Publications/ Presentations

Evaluating the Use of Total Organic Carbon (TOC) for Pharmaceutical Cleaning Validation (CV)/Verification of Phase I and Phase II Drug Candidates, Charles Pacheco, D. Knight, C. Bryant, 50th Rocky Mt. Conference on Analytical Chemistry, Breckenridge, CO, July 2008.

Interaction Forces between Metal-Chelating Lipid Monolayers Measured by Colloidal Probe Atomic Force Microscopy, Ishiguro, R.; Sasaki, D. Y.; Pacheco, C.; Kurihara, K. Coll. and Surf. A, 1999, 146, 329.

H1 and C13 NMR Characterization of Deoxyhemigossypol Derivatives, CIMD Program, December, 1994, Charles A.

Pacheco, Todd M. Alam, and Lorraine Deck.

Professional Training

Out of Specification Results, 2011

Pharmaceutical Production Batch Record Review, 2010

Stability Programs for Product Shelf Life - From Development to Approval, 2008

Auditing and Qualifying Suppliers and Vendors, 2007

The Analytical Laboratory in a Regulated Environment, 2007

GC Fundamentals, Applications and Troubleshooting, 2007

Advance HPLC in Pharmaceutical Analysis, 2006

Empower Software Advanced Topics Training, 2006

Hazardous Waste Operator (HAZWOPER), certified, 1999, recertified 2006

Chromatography Institute of America, 2003

Maintenance and Troubleshooting, SLC-500 Controllers School (Allen Bradley), 2000

Hazardous Materials Handling for DOT 49 CFR Transportation Regulations, certified, 1999

Academic Research/Internships

1996-1998: Student Intern, Sandia National Laboratories, Organization 1811, Materials Aging and Reliability

Multi-step syntheses, purification, and characterization of artificial lipid and sol-gel materials (Dr. Daryl Sasaki)

Preparation of monolayer precursor solutions (Dr. Robert Rye)

1994-1995: Research Assistant, University of New Mexico, Department of Chemistry

Synthesis, purification, and characterization of oxacalixarenes and azacalixarenes (Professor Philip D. Hampton)

1994: CIMD Research Assistant, University of New Mexico, Department of Chemistry

H1 and C13 NMR characterization of deoxyhemigossypol derivatives (Dr. Todd M. Alam)

United States Navy, USS Nimitz, CVN-68 1986-1992

Naval Nuclear Propulsion Operator

Responsibility: Monitoring and control of Nimitz class nuclear reactor during online and shutdown operations. Maintained electrical equipment through scheduled preventative maintenance and troubleshooting. Extensive electronic technical experience including basic and advanced electrical theory, logic circuits, system schematics and diagrams, and hands-on experience troubleshooting circuits and solid state devices.

Southwest Asia Campaign Service Medal with Bronze Star, National Defense Medal, Good Conduct Award, Honorably Discharged (rank E-5)

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