Todd Lewis has over 20 years of experience in analytical development and quality control, currently serving as Associate Director of Analytical Development at Roxanne Laboratories. He oversees method development, validation, and cGMP testing to support 8-10 ANDA filings annually. Lewis manages a staff of 20 analysts and has experience interacting with regulatory agencies. Prior to his current role, Lewis held positions with increasing responsibility at Mylan Pharmaceuticals and UDL Laboratories, gaining experience in separations techniques, method development, validation, and management.

1. 576 Bridle Drive
Marysville, OH43040
614-592-6763
jestertwl@gmail.com
TODD LEWIS
SKILLS & ABILITIES Experienced in method development and validation for the support of
ANDA filings and formulation development. Perform trend analysis of
data and conduct investigations for OOS and OOT results and well
versed in CAPA remediation. Trained in various analytical techniques
and actively seeks innovative approaches to improve quality and
efficiencies of methodologies to decrease development time. Trained in
management of staff with regards to career development, technical
competency, performance management and mentorship. Trained in
project management and priority setting, analysis of project constraints
and mitigation to achieve deadlines. Experienced in regulatory
interactions through audit and correspondence with multiple regulatory
agencies.
EXPERIENCE ASSOCIATE DIRECTOR, ANALYTICAL DEVELOPMENT, ROXANNE LABORATORIES
July, 2002 - Present
 Overseeing method development and method validation for the
purpose of 8 to 10 ANDA submissions a year with an emphasis
on QbD and QbR. Experienced in the filing activities for IND’s,
ANDA’s and NDA’s for solid dosages (IR, MR, & ER), oral
dosages (solution and suspension), nasal sprays, multi dose
inhalers, sublingual, topical formulations (creams and patches)
and injectable products.
 Manage three supervisors and staff of 20 analysts with regards
to performance appraisals and growing talent, mentorship,
career development, interviewing, coaching of staff in method
development, method validation, cGMP testing and career
aspirations.
 Draft and update job profiles for scientists, supervisory positions
and business support roles.
 cGMP release of product for clinical trials and stability testing
with emphasis on trending for the purpose of establishing
commercial specifications for drug products. Conduct
laboratory investigations for OOS and OOT results pertaining to
both development and commercial products.
 Interact with the FDA during onsite audits; correspondence in
relation to ANDA deficiency letters, CBE0 and CBE30, PAS,
Annual Reports, onsite PAI and general cGMP inspections.
 Monitor budget as well as developing future budgetary plans for
personnel and equipment.
 Prepare and review SOP, Work Instruction, Specifications,
Procedures and guidance for laboratory use with an emphasis
on compliance.
 Develop and oversaw designs for new laboratory space with

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compliance considerations for both FDA and DEA agencies.
Took several projects from design phase, through construction
and completed with regulatory inspections for final occupancy
and cGMP activities.
 Drive the acquisition of new technologies and software to
increase the efficiency of development work to reduce timeline
to submission. UPLC, Apparatus IV dissolution, ASD apparatus
(Artificial Stomach Duodenum) and ASAP (Accelerated Stability
Assessment Program) software to model degradation pathways
to predict stability trends, packaging optimization and
formulation optimization.
Accomplishments:
 Trained and experienced in UPLC, HPLC, GC, TLC, DSC, TGA,
FTIR, AA, X-ray diffraction, SEM, Dissolution, NIR, and Karl
Fischer.
 Attended extensive management training conducted by the
Fisher College of Business at Ohio State University.
 Oversaw construction project of a high contaminate operation
for both R&D and quality control laboratories ensuring budget
and timelines were adhered. Project included design phase,
construction phase, transition of equipment and staff between
sites. Completed project with an extensive FDA auditor with a
success cGMP approval.
 Attended several GPhA conventions, relaying critical
information on ICH expectations and developed strategies to
address resource deficiencies based upon the new stability
requirements. Attend several project manager workshops with
FDA at multiple fall conventions.
 Presented to the Fisher College of Business Health Case
Industry Cluster.
 Sponsored, coached, and participated as a team member on
several process improvement teams.
 Promoted three times within the research and development
department.
ASSISTANT LABORATORY MANAGER, RESEARCHJ & DEVELOPMENT, MYLAN
PHARMACEUTICALS, INC.
October 1996 – July, 2002
 Applying separation techniques to liquids, solid dosages,
creams, suspensions, and parenterals for methods
development and methods validation for the submission of
ANDA’s.
 Managing a staff of four employees to support the development
of viable generic drug formulations, new drug formulations, and
re-formulation of current approved generic drugs.
 Qualification, release, and resolving technical issues involved
with drug substance, drug product and excipients for cGMP
environment.
 Creation of CMC sections for IND, NDA and ANDA submissions
for FDA.
 Management responsibilities include performance appraisals,
interviewing candidates, scheduling priorities, and handling day
to day morale of the laboratory.

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Accomplishments:
 Attended extensive Management training conducted by the
College of Business at West Virginia University.
 Promoted twice within the research and development
department.
 Trained in HPLC, GC, TLC and HPTLC, DSC, TGA, FTIR,
Raman Spectroscopy, AA, X-ray diffraction, SEM, Dissolution,
and Karl Fischer.
RESEARCH & DEVELOPMENT CHEMIST, UDL LABORATORIES, INC.
June, 1994 to October, 1996
 Performed methods development and validation of analytical
methodology for liquid formulations for ANDA submissions.
 Prepared validation reports for ANDA submissions.
 Wrote and revised SOP material.
 Developed calibration procedures for FTIR with microscope,
DSC, and TGA.
 Trained R&D staff on the use of DSC, TGA, FTIR with
microscope, Dissolution, and Coulter particle size analyzer.
Trained R&D and Q.C. staff on separations involving HPTLC
and conventional TLC.
 Performed maintenance on GC and established methods for
quantitation using packed and capillary columns. Attended
training seminars on HPTLC, FTIR, and DSC.
 Promoted from quality control department to research and
development department. Promoted once within the research
and development department.
QUALITY CONTROL SHIFT LEADER, ZEPHYRHILLS BOTTLED WATER CO.
April, 1993 to June, 1994
 Evaluation of product quality throughout manufacturing process.
 Development of raw material testing protocols.
 Performed audits and on site inspections of proposed and
current raw material vendors.
 Trained in process qualification, validation, and certification.
 Sampling and biological testing of water. Certified in wastewater
management.
EDUCATION GANNON UNIVERSITY, ERIE, PA – BACHELOR’S OF SCIENCE
Chemistry
1988-1992
TEMPLE UNIVERSITY, PHILADELPHIA, PA – MASTERS
Quality Assurance and Regulatory Affairs
2005-2009

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REFERENCES AVAILABLE UPON REQUEST