Lois E. Horne, Ph.D.

(315) 525-7732 lois_nice@hotmail.com

Qualification Highlights
Quality Assurance and Regulatory Affairs - Proven expertise in delivering quality strategies that meet project
timelines such as process validations, equipment qualifications, method validations or transfer and cleaning method
validations prior to manufacture of customer products. This also includes a regulatory review, domestic and
foreign (such as Canadian, EU) of product labeling, formula design (i.e. Prop 65, REACH) and packaging
compliance.
Quality Assurance - Director with 6 years of experience reviewing and approving technical documentations such
as Quality Variance Reports (Manufacturing deviations), Laboratory Investigation Reports and Validation
protocols and reports for both analytical and manufacturing processes. Participated in supplier audits for analytical
services to ensure compliance with GMPs and internal SOPs. Successfully hosted two FDA audits with no 483s
issued (Agro-Farma, & Marietta Corporation). Apply lean tools to determine root cause for quality outages and
ensure the corrective and preventative actions are sustainable and prevent reoccurrence. Work with operational
team to drive continuous improvements (cost reductions, quality improvements, new system implementations).
Experience in medical device manufacture and regulatory submissions.
Analytical Chemistry - Project Manager with 16 years of experience as an Analytical project manager.
Experienced in Contract Organizations (Manufacturing or Analytical Research) management. Experienced in
analytical testing associated with quality control, stability, and method validation or technology transfers.
Experience with conducting laboratory investigations, determining corrective and preventative actions, change
control systems, management of multiple products and multiple analysts, and in equipment management like
validation/calibration and repair.
Chemical Synthesis - Comprehensive background in scientific ideas, programs, methods and disciplines.
Experienced in the synthesis, analysis and characterization of various organic and pharmaceutical compounds.
Project skills include analytical techniques such as HPLC, UV, IR, GC-MS, NMR, DEPT, 1H, 13C, NOESY,
COSY, and 2D.
Pharmaceutical Analysis Highly experienced in Pharmaceutical testing of solid dosage forms, liquids and semisolids. Experience in analytical testing for assay, impurities, dissolution, hardness, water content, friability, torque,
disintegration, enantiomeric purity, and identity testing.
Organizational - Quick study, able to rapidly achieve organizational integration, easily assimilate job
requirements and aggressively employ new ideas, concepts, and technologies. Innovative and self-motivated team
player/builder. Effectively manage multiple and concurrent responsibilities. Able to work within a diverse work
environment.
Communications - Superior communication skill set, interpersonal, research/analysis, organizational, problem
solving and leadership skills. Co-author of numerous abstracts and publications. Acknowledged public
speaker/lecturer.
IT Proficiency - skilled in the use of Windows operating systems as well as a variety of research management
applications such as Empower, Chemstation, Total Chrom, Excel, ChemDraw, SQC and other Microsoft Office
programs.
Manufacturing - experienced with SMED events, 5 S process, root cause analysis and risk assessment. Able to
apply DMAIC principles to measure, analyze and improve processes associated with ensuring quality assurance
within a regulated industry while lessening operational cost. Developed and monitored metrics to measure
performance of a process and implemented single interval control.

L. Horne, Ph.D. curriculum vitae

Page 2

Education
Clemson University Clemson, SC
Ph.D., Organic Chemistry 1999

Lycoming College Williamsport, PA

B.A., Chemistry Minor: Biology 1993

Employment History
Jan 2014 Sept 2016 (Position Elimination)
KIK Custom Products
Memphis, TN
Supplier Technology Development Associate Fellow, Divisional Quality
In charge of Supplier Quality ensuring that vendors perform accurate root cause analyses, implement corrective actions
and work with KIK manufacturing site to troubleshoot manufacturing issues in blending and packaging.
Quality Assurance Manager
In charge of Quality department with 26 direct reports. Oversee all quality operations including online quality auditors,
laboratory personnel and quality release team.
March 2013 Jan 2014
GXP Solutions
Waterville, NY
Quality System Consultant/Owner
Assisted my clients with SOP reviews and recommended changes based upon industry guidelines
Assembled annual drug product reports for several drug products.
Performed technology transfers (process and quality systems) from one organization to another organization (3 rd party).
Continuous Improvements and troubleshooting for compounding and manufacturing issues
October 2009 2013
Marietta Corporation
Cortland, NY
Director of Quality Assurance
Support the operations of the following departments: Analytical, Microbiology, Incoming QA, Validation, Document
Control, and R&D.
Manage Quality Assurance of two facilities utilizing 10 direct reports and 34 indirect reports.
Successfully hosted 1 audit from FDA, and several customer audits (10+ audits from customers ranging from
Pharmaceutical companies to companies with interests in health and beauty care products).
Lead or participate in several teams ranging in scope from safety, quality, productivity and cost reduction.
May 2009 October 2009
Agro-Farma Inc (AFI)
New Berlin, NY
Quality Assurance Specialist (Contract)
Manage the QC laboratory, develop quality systems and SOPs for entire plant, investigate and perform root cause
analysis for customer complaints, host regulatory audits (3rd Party, Organic) and prepare regulatory documentation
(Export documentation and certification applications).
2005 2009 (Laid-off)
Norwich Pharmaceutical (NPI)
Norwich, NY
New Business Initiatives Management Department Manager Method Transfer
QA Manager of Technical and Regulatory Affairs
Controlled substance officer and host DEA and NYBNE audits. Supervise the designated representative in charge and
ensure compliance with multiple state board of pharmacy requirements for NPIs business operations.
Responsible for communicating with customers and understanding their regulatory stability requirements for products
manufactured and tested by NPI. This includes managing the stability sample coordinator and reviewing annual reports as
they relate to stability requirements.
Responsible for the technical review of QC laboratory investigations, SOPs and method approval.
Supervise and coordinate QA Method Development analysts performing method development/validation and technology
transfer.
Perform investigations into process deviations and devise systemic resolutions to mistake proof the process for the future.
QC Stability Manager
Responsible for the operation of the stability testing, which includes the responsibility of quoting the project, protocol
approval, ensure samples are pulled from the environmental chambers, tested and reported on time per contractual
agreements and regulatory requirements. Perform trend analysis and evaluate if test results exceeds limits from last time
interval or initial testing per ICH guidelines.
Assist in the preparation of annual product reviews and statistical analysis for data trending.
Supervise and coordinate QC release testing for selected products and all stability testing within the company.
Perform investigations into process deviations and devise systemic resolutions to mistake proof the process for the future.

L. Horne, Ph.D. curriculum vitae

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Responsible for environmental chamber maintenance, calibration and managing the troubleshooting in the event of an
alarm.
QC Team Leader
Responsible for the planning, technical leadership, operational coordination and quality aspects of the QC release
workload for at least four pharmaceutical products with varying strengths.
Supervise and coordinate pharmaceutical QC release testing group operations and staff (4-6 analysts).
Perform quality control review of analytical data (HPLC, dissolution, UV and IR spectroscopy, Karl Fischer), laboratory
notebooks and scientific investigational reports (OOS, OOT and method deviation).
Responsible for managing the second shift operations of the Quality Control Laboratory and assisting with quality related
questions from the production staff during 2 nd shift operations.
Interact with customers regarding technical investigations or assessing their analytical testing requirements for nonroutine or new stability programs.
2002 2005
Prevalere Life Sciences
Whitesboro, NY
Project Manager/ Project Leader
Responsible for planning, quotation preparation, technical leadership, operational coordination, and quality aspects of the
workload.
Supervise and coordinate pharmaceutical product testing group operations and staff (3-7 analysts).
Responsible for management and technical training of subordinate staff.
Directly responsible for laboratory and instrumental operations including analytical method development (HPLC,
Headspace, GC, etc.)
Troubleshoot and resolve technical issues, act as technical consultant to the analysts for lab procedures and
instrumentation (HPLC, GC, dissolution, Karl Fischer, headspace, plume geometry, etc.).
Supervise and coordinate pharmaceutical product testing group operations and staff (3-5 analysts).
Manage stability programs, method development and other technical studies. Editor of company SOPs pertaining to
HPLC equipment and other instrumentation. Manage instrument preventative maintenance and calibration.
Troubleshoot and resolve technical issues, act as technical consultant to the analysts for lab procedures and
instrumentation (HPLC, GC, dissolution, Karl Fischer, headspace, plume geometry, etc.).
Review data and notebooks, and assure regulatory compliance. Perform pharmaceutical product testing/dosage form
testing/ stability analysis and report generation. Ensure the laboratory work is compliant with SOPs/procedures and
cGMP.
Communicate and coordinate with clients to ensure an efficient and timely testing regime and schedule.
2000 2002
Equi-Tox, Inc.
Central, SC
Research Chemist / Special Projects Leader
Assist in development and implementation of c-GMP and GLP operations for a startup pharmaceutical company.
Summarize research data and prepare the chemistry section on a new animal drug submission, Equidone Oral Gel.
Manage all activities of analytical and quality control labs; perform method validation of analytical methods for NADA
submission, managed contract manufacturer and contract research organization and tested the formulation itself in an
effort to improve robustness and consistency of the oral gel.
Initiate methods, specifications, batch records and procedures to ensure efficient/organized research and product
development and bring manufacturing and warehousing facility up to OSHA and c-GMP standards. Serve as Registered
Pharmacy Technician to ship product out to veterinarians via prescription.
1999 2000
Research Triangle Institute
Research Triangle Park, NC
Post-doctoral Chemist
Designed studies for the synthesis of conformationally restricted anandamide analogs, including preparation of skipped
diene systems. Organized pre-study preparation, obtain/analyze data, and compile reports outlining experimental
protocols and research results. Developed unique routes/protocols, ordered raw materials, interpreted spectroscopic data,
and participated in weekly group progress reports. Assisted bachelor-level chemists with various projects and
spectroscopic interpretations. Managed laboratory during Supervisors absence and maintained access to secure vaults
containing regulated materials.

Honors and Awards

2006 Site Leadership Award for Excellence

2007 Customer Appreciation Recognition for my Excellence and Ownership of Macrobid
2011 Marietta Corporation Received Vendor Award from a Strategic Beauty Care Product Contract Custom