CHRISTOPHER MORCIGLIO CMORCIGLIO8872@YAHOO.COM55 Copperdale Drive, Simpsonville, SC 29681

(C) 845-598-7645

MANAGEMENT PROFILE A highly skilled pharmaceutical professional with broad-based experience

• Quality Assurance • Manufacturing • Packaging • Quality Control • New Product 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 – PresentPatheon, Incorporated, Greenville, SC 29605Senior Manager, Quality Control

-Direct supervision of 18 laboratory chemists, data reviewers, and lab assistants-Daily interface with internal teammates in Production, QA, Engineering, and EHS to achieve on-time delivery of Active Pharmaceutical Ingredient (API) by effective scheduling and prioritization of sixteen (16) unique active projects-Serve as QC’s face to the customer for ongoing projects, from clinical all the way through commercialization-Evaluation/review/approval of OOSs, DRs, PQIs, OIs, Validation Protocols, Process PQ Protocols, Method Validation Protocols and Approval Reports, Method Transfers, Stability Reports-Composition of Reference Standard Requalification Protocols for customer information/approval-Engages in sitewide improvement initiatives as member of Site Leadership Team (SLT)-Hosts visitors to the QC Lab on site visits or audits-Served as QC Owner of Organization Excellence (OE) initiatives and GLASS project, bringing Empower to QC

09/11 – 04/16Watson/Actavis/Allergan, Parsippany, NJ 07054 Manager, Third Party Quality Assurance

-Provide management and quality oversight of one hundred twelve products, across nineteen different TPMs.-Provide review and approval of protocols, reports, investigations, change controls and/or deviations associated with process validation, method validation, shipping studies, routine production, process changes, Regulatory and audit findings.-Currently managing eighteen products in either R&D or pre-launch stage-Provide QA support for customer complaint tracking, trending and closure-Review and approval of incoming APRs from TPMs, initiating feedback and dialogue where needed-Saw opportunity to reduce cost of stability spending by company by eliminating testing past expiration date. Savings would be in excess of $365K. Removal of other time points is under evaluation. -Developed, with site USP liaison, a compendial compliance program for tracking our TPMs’ USP compliance

08/09 – 09/11Purdue Pharma, LP, Totowa, NJ 07512Manager, Supplier Quality Assurance

-Quality oversight of 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 complaint closure, up to and including investigation and approval.

11/04-08/09Barr Labs, Pomona, NY 10970Senior External Quality Associate

-Quality review and signoff of Method Validation Protocols, Product Specifications, Master Batch Records, Stability Protocols, Analytical Methods and corresponding Validation Reports.

-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 test method 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 – 11/04Vyteris Inc, Fairlawn, NJ 07410Analytical Services Auditor

-Review of laboratory-generated data for stability, release and protocol efficacy demonstration-Review of protocols, SOPs, and IQ’s, OQ’s, PQ’s for content and regulatory compliance-Performed internal compliance audits of the laboratory areas and their related functions -Conducted training sessions for laboratory scientists and technicians, covering documentation, regulatory compliance, and test method improvements-Performance of internal investigations, including Out of Calibration Investigations, Out of Specification Investigations, and internal audit follow-ups

11/03 – 12/03Mustang Biopharm, Philadelphia, PA, assignment in Pearl River, NY, Wyeth LaboratoriesPharmaceutical Consultant - Temporary

-Organizing and facilitating the creation of PMO’s for both GMP critical and non-critical instrumentation

08/95 – 11/03Novartis Pharmaceuticals Corporation, Suffern, New York, 10901 12/97 – 11/03 Chemist, Quality Control Unit

-Performed finished product and stability testing on over fifteen different finished goods.-Troubleshooting of analytical and instrumentation problems, and performance of internal audits and investigations.-Validation of paperwork and batch work needed for batch release and ongoing stability.

12/96 – 12/97 Manufacturing Supervisor, Compression/Capsulation/Branding -Ensuring that production objectives for units are set and met, as well as integration of company goals.-Maintain a positive work environment, foster a positive/supportive culture, and boost morale whenever possible.-Ensuring of product quality within the business, “First Time Right”.-Support of technical training for the unit to include equipment, product and process training, cGMPs, SOPs, HAZCOM, and safety.

12/95 – 12/96 Supervisor, Quality Assurance-Monitoring of the site’s manufacturing, packaging, and warehouse operation to assure compliance with cGMPs and SOPs, via periodic and random internal audits and area checks.-Making decisions as to whether or not production operations should begin, continue, or be modified.

8/95 – 12/95 Inspector, Quality Assurance-Inspection of integrated packaging and transdermal lines to ensure cleanliness and readiness for operation.-Performance of in-process tests and review of completed batch records

9/94 – 4/95Lederle Laboratories, Pearl River, New YorkClinical Trials Coordinator

-In-house development of mathematical/statistical representations of blind, double blind, and placebo/blind drug studies, and fabrication of clinical kits for those developed studies.

EDUCATION:Saint Thomas Aquinas College, Sparkill, New York, 10976Bachelor of Science degree in Chemistry with specialization in Natural Sciences, May 1994, Cum Laude