1. CHRISTOPHERMORCIGLIO CMORCIGLIO8872@YAHOO.COM
55 Copperdale Drive, Simpsonville, SC 29681
(C) 845-598-7645
MANAGEMENT PROFILE
 A highlyskilledpharmaceutical professional with broad-basedexperience
• Quality Assurance • Manufacturing • Packaging • QualityControl • NewProduct Launches
 Proven track record of launching new products with Third Party Suppliers.
 Excels at building quality customer relationships, both internal and external.
 Cross-functional team leader with ability to motivate and partner all customers
 Strong negotiation, persuasion, problem solving, and persistence skills.
04/16 – Present
Patheon,Incorporated, Greenville,SC29605
SeniorManager, QualityControl
-Direct supervision of 18 laboratory chemists,data reviewers,and lab assistants
-Daily interfacewith internal teammates in Production, QA, Engineering, and EHS to achieveon-time delivery
of Active Pharmaceutical Ingredient(API) by effective schedulingand prioritization of sixteen (16) unique
activeprojects
-Serve as QC’s face to the customer for ongoing projects,from clinical all theway through commercialization
-Evaluation/review/approval of OOSs,DRs, PQIs,OIs,Validation Protocols,ProcessPQ Protocols,Method
Validation Protocolsand Approval Reports,Method Transfers,Stability Reports
-Composition of Reference Standard Requalification Protocolsfor customer information/approval
-Engages in sitewideimprovement initiativesas member of Site Leadership Team (SLT)
-Hosts visitors to the QC Lab on sitevisits or audits
-Served as QC Owner of Organization Excellence(OE) initiatives and GLASS project, bringingEmpower to QC
09/11 – 04/16
Watson/Actavis/Allergan, Parsippany,NJ 07054
Manager, ThirdParty QualityAssurance
-Providemanagement and quality oversightof one hundred twelve products,across nineteen different
TPMs.
-Providereview and approval of protocols,reports, investigations,changecontrols and/or deviations
associated with process validation,method validation,shippingstudies,routineproduction,process
changes, Regulatory and auditfindings.
-Currently managing eighteen products in either R&D or pre-launch stage
-ProvideQA support for customer complainttracking,trendingand closure
-Review and approval of incomingAPRs from TPMs, initiatingfeedback and dialoguewhere needed
-Saw opportunity to reduce costof stability spendingby company by eliminatingtestingpastexpiration date.
Savings would be in excess of $365K. Removal of other time points is under evaluation.
-Developed, with siteUSP liaison,a compendial complianceprogramfor trackingour TPMs’ USP compliance
08/09 – 09/11
Purdue Pharma, LP, Totowa, NJ 07512
Manager, SupplierQualityAssurance
-Quality oversightof four projects from four different CROs/CMOs, with successful January 2011 launch
-Quality review and signoff of Method Validation Protocols, Product Specifications, Master Batch Records,
Stability Protocols, Analytical Methods and Validation Reports in support of launch/commercial needs.
-Review/audit executed and non-executed batch records and perform final QA release of product.
-Investigation and completion of OOS and OOT results,both internal and external and respective CAPAs from
incidents occurring at third party CMOs.
-Customer complaintclosure,up to and includinginvestigation and approval.
11/04-08/09
Barr Labs, Pomona, NY 10970
Senior External Quality Associate
-Quality reviewand signoff of Method Validation Protocols,ProductSpecifications,Master Batch Records,
Stability Protocols, Analytical Methods and corresponding Validation Reports.

2. -Facilitation of the achievement of objectives leading to ANDA submissions, including adherence to
project timelines regarding quality/production/packaging document signoff and approval, protocol
signoff and approval,analytical testmethod signoff and approval,and final report signoff and approval.
-Review/audit executed and non-executed batch records and perform final QA release of product.
-Write internal and evaluate external investigations, deviations, CAPAs and change controls.
-Review and prepare specifications for raw materials and finished products.
-Investigation and follow-through to completion of OOS and OOT results generated at third party CMOs.
01/04 – 11/04
VyterisInc, Fairlawn, NJ 07410
Analytical ServicesAuditor
-Review of laboratory-generated data for stability,releaseand protocol efficacy demonstration
-Review of protocols,SOPs,and IQ’s,OQ’s, PQ’s for content and regulatory compliance
-Performed internal complianceaudits of the laboratory areas and their related functions
-Conducted trainingsessions for laboratory scientists and technicians,coveringdocumentation,
regulatory compliance,and test method improvements
-Performance of internal investigations,includingOutof Calibration Inves tigations,Outof Specification
Investigations,and internal auditfollow-ups
11/03 – 12/03
Mustang Biopharm, Philadelphia,PA,assignmentinPearl River,NY, WyethLaboratories
Pharmaceutical Consultant - Temporary
-Organizingand facilitatingthecreation of PMO’s for both GMP critical and non-critical instrumentation
08/95 – 11/03
Novartis PharmaceuticalsCorporation, Suffern,NewYork, 10901
12/97 – 11/03 Chemist,QualityControl Unit
-Performed finished productand stability testingon over fifteen different finished goods .
-Troubleshootingof analytical and instrumentation problems,and performance of internal audits and
investigations.
-Validation of paperwork and batch work needed for batch releaseand ongoing stability.
12/96 – 12/97 ManufacturingSupervisor,Compression/Capsulation/Branding
-Ensuringthat production objectives for units areset and met, as well as integration of company goals.
-Maintain a positivework environment, foster a positive/supportiveculture,and boost morale
whenever possible.
-Ensuringof product quality within the business,“FirstTime Right”.
-Support of technical trainingfor the unit to includeequipment, product and process training,cGMPs,
SOPs,HAZCOM, and safety.
12/95 – 12/96 Supervisor,QualityAssurance
-Monitoringof the site’s manufacturing,packaging,and warehouse operation to assurecompliancewith
cGMPs and SOPs,via periodic and randominternal audits and area checks.
-Making decisions as to whether or not production operations should begin,continue, or be modified.
8/95 – 12/95 Inspector,QualityAssurance
-Inspection of integrated packagingand transdermal lines to ensure cleanliness and readinessfor
operation.
-Performance of in-process tests and review of completed batch records
9/94 – 4/95
Lederle Laboratories, Pearl River,New York
Clinical TrialsCoordinator
-In-housedevelopment of mathematical/statistical representations of blind,doubleblind, and
placebo/blind drugstudies,and fabrication of clinical kits for thosedeveloped studies.
EDUCATION:
SaintThomas Aquinas College,Sparkill,New York, 10976
Bachelor of Science degree in Chemistry with specialization in Natural Sciences,May 1994, Cum Laude