Project Manager Quality Control

Matthew D. Grant

*** ******** ***. ********, **** 43206 419-***-**** +

abknnv@r.postjobfree.com

Professional Profile

Self-motivated professional with extensive knowledge of FDA 21 CFR, GMP,

GLP, GCP and ICH Quality and Regulatory compliance. An organized and

versatile individual who exemplifies professionalism and the ability to

manage multiple projects and responsibilities efficiently. Demonstrated

history of successful project management and team leadership, evidenced by

the ability to work with people from numerous departments and backgrounds

to achieve corporate goals.

Work Experience

Neoprobe Corporation - Dublin, Ohio

Regulatory Affair Manager (2010-Present)

. Supervise the coordination, content and format (CTD and eCTD), of IND,

BLA, NDA, 510(k), PMA, supplements and amendments for domestic and

foreign regulatory submissions

. Ensures all government and international report systems and documentation

comply with regulatory requirements for therapeutic, medical, and

diagnostic products

. Provide regulatory strategy input to project teams and peers, and assists

in development of project objectives, timelines and budgets

. Review technical production data; verify accuracy of clinical data and

execution of clinical projects

. Assist in the establishment and maintenance of regulatory documentation,

QMS procedures, work instructions (SOPs) and records

. Working knowledge of FDA, TPB, EMEA, ICH, ISO, European directives for

product registration, Canadian and Japanese regulations for drugs and

devices

. Monitor the US and international regulatory environments, and provides

senior management with assessments of the impact of new and changing

regulations

Camargo Pharmaceutical Services - Cincinnati, Ohio

Regulatory Submissions Project Manager (2007-2010)

. Directly assisted the Senior Director of Regulatory and Quality

Compliance and supervise two Regulatory Affairs Associates in the

coordination, preparation and review of various regulatory submissions

(NDAs/ANDAs/INDs/DMFs) and related maintenance documentation (amendments,

supplements, annual reports, etc.)

. Led the assessment, analysis, and implementation of more than 100 FDA

regulatory submissions

. Successfully implemented an SPL/eCTD submission preparation process

utilizing XForms, Extedo eCTD manager, SharePoint, and other related

programs/software based on client need

. Critically reviewed local and foreign SOPs, batch records, analytical

data, protocols, and technical documents for 21 CFR/ICH compliance and

suitability for regulatory filing

. Experienced in the CMC strategy and management process from development

to commercial phases

. Actively participated in PAI, supplier and vendor audits to identify

potential nonconformance items

. Interacted regularly with the FDA, foreign agencies and executives from

various levels of the industry

. Monitor and investigate the daily federal register, FDA internet updates

and trade press notices for changes in regulations or regulatory policy

that may impact internal operations and/or regulatory compliance

Alkermes Pharmaceutical - Wilmington, Ohio

Stability Coordinator/QC Chemist III (2002-2007)

. Site lead for the GMP Quality Control Stability program

. Supervised two Stability Technicians and monitor Quality compliance of

the QC laboratories

. Prepared, executed, and summarized stability studies spanning multiple

sites, products, and dosage strengths intended for regulatory submission

in compliance with cGMP industry standards and ICH guidelines

. Organized and interpreted statistical data and trends for stability

studies designed to support process validation, annual commitment, expiry

assignment, IND, NDA, and Annual Report submissions and amendments

. Drafted stability study protocols, and final reports utilizing JMP, SLIM,

Oracle, Trackwise, and Microsoft applications

. Initiated and summarized non-conformance investigations, deviation

reports, and CAPA items

. Participated in multiple internal, external customer, FDA and MHRA audits

Quality Control, Finished Product Chemist II

. Analyzed finished product, raw material, and polymer samples utilizing

HPLC, GC, GPC and UV instrumentation

. Performed instrument qualification, method validation, and annual

calibrations

. Trained new analysts on instrumental techniques and served as a technical

resource for the QC laboratory

. Executed laboratory investigations and prepared problem reports for

product failures and/or method deviations

. Developed excellent GMP documentation skills

Akzo Nobel Chemicals - Lima, Ohio

Lead Chemist - Quality Control (2000 - 2002)

. Directly assisted the QC Manager in supervising laboratory activities at

an ISO 9000 certified facility

. Supervised 3 lab technicians performing routine analysis of products for

internal and external customers employing knowledge of HPLC, GC, UV, GPC,

and CE instrumentation

. Scheduled incoming tests and product release dates, while providing

timely updates to management staff

. Developed and implemented Standard Operating Procedures and trained

production and technical personnel on reagent preparation, various

titrations, and distillations

Springborn Laboratories - Spencerville, Ohio

Reproductive Toxicology Laboratory Technician (1998 -2000)

. Executed nonclinical reproductive toxicity studies within a GLP regulated

laboratory

. Studied the effects of fertility, early embryonic, embryo-fetal, pre and

postnatal development

. Experienced in dosing techniques (oral gavage, oral capsule, intravenous,

subcutaneous, and patching)

. Developed fundamental GLP documentation and data compilation skills

Education

. Sinclair Community College, Dayton, Ohio - Associate of Science,

Chemistry (2005)

. Ohio University, Athens, Ohio - Bachelor of Technical and Applied

Studies (Expected 2011)

Affiliations & specialized training

. Member of American Chemical and Regulatory Affairs Professionals

Societies

. Registered to complete the US RAC (Regulatory Affairs Certification) exam

in fall 2010

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