• Extensive experience in CMC, particularly in small molecule development and manufacturing of finished dosage forms including tablets, capsules, injectables and liquids. • Broad based experience in “hands-on” technical and timeline management of contract manufacturing and formulation development companies. • Experience in working at small to medium sized companies has resulted in extensive experience in multitasking including: formulation development, process development/scale-up, managing all phases of analytical development including analytical methods validation and transfer, managing stability programs, technical transfer, registration batch manufacturing, clinical supply manufacturing (Phases I to III), validation batch manufacturing, equipment validation, cleaning validation, technical support of commercial manufacturing, and troubleshooting commercial processes. • Knowledge of US and European contract manufacturing sites including identifying and selecting contract formulation/manufacturing firms, reviewing and finalizing contract proposals (Master Services Agreements, Secrecy Agreements, and Work Proposals), execution of the contracts, and maintaining a timeline and budget for each manufacturing/development project on a project basis. • Strong experience in managing a multi-functional team of company technical personnel and contract manufacturing personnel to achieve critical milestones in a timely fashion. • Ability to streamline manufacturing processes and reduce manufacturing costs. • Cross-functional experience in Quality Assurance including participation in the successful PAI (Pre-Approval Inspection) of a company’s lead commercial product candidate. Specialties: Experience in Project Management including creating and maintaining time-lines using Microsoft Project. Well versed in all Microsoft Office tools including Word, Excel, and Power Point.

Consultant @ • Product Development Expertise: o Provide technical guidance and oversight of third party manufacturing contractors (CMOs) on behalf of Client Company in support of formulation, process development, and validation activities (process validation, equipment qualifications) for finished drug product. o Review and evaluate batch manufacturing records, reports and protocols for process development, technical transfer, validation, and troubleshooting activities for commercial finished drug product. o Write/review NDA support documentation and NDA drug product sections. • Quality Assurance Expertise: o Review of master and executed batch records (development, validation and commercial). o Conduct review and assessment of regulatory deficiency responses. o Remediate compliance deficiencies observed from FDA 483 observations, other regulatory agencies (MHRA, EMEA) and independent third party audits. o Revised/Strengthen quality documentation systems such as Trackwise (i.e., tracking complaints, deviations, investigations, root cause analysis, and CAPAs). o Proficient in the utilization of Livelinks and Trackwise. o Write/Review and close out deviations, investigations, and CAPAs. o Conduct stability assessments for finished drug product. From June 2011 to Present (4 years 7 months) Senior Manager @ Wrote Complaint and Field Alert SOPs in support of commercial launch of lead product. Prepared the Quality Systems Quarterly Management Review Meetings for Complaints/Field Alerts and presented to the Quality Systems Team. Participated in the review of finished drug product NDA sections for FDA submission of lead finished drug product. Team Lead and participated in audits of CMOs and drug product component/excipient vendors. Coordinated a multifunctional department team and participated in writing and revision of SOPs necessary to support a successful PAI (Pre-Approval Inspection) and commercial launch of the company's lead finished drug product. Managed and participated in the preparation of all regulatory agency presentations in support of onsite regulatory inspections and company manufacturing site in Switzerland. Participated in the writing and execution of quality and supplier agreements. Participated in the successful PAI (No Action Indicated from EIR) of the company's lead commercial product candidate. From June 2009 to March 2011 (1 year 10 months) Senior Manager @ PROMOTION From October 2006 to June 2009 (2 years 9 months) Manager, Product Development @ Manage all phases of CRO outsourced Finished Drug Product Projects including Formulation Development, Process Development, Scale-Up, Clinical Supply Manufacturing, and Technology Transfer for Commercialization. Team Leading lead NCE candidate that includes reviewing and negotiating project proposals with time-lines. Responsible for writing, reviewing and providing feedback for batch records, protocols, and reports to CRO and Arena personnel in pharmaceutical sciences department. Organizing and conducting regular cross-functional team meetings between Arena and CRO's to maintain target time-lines for project. Provide direction and feedback to other team members to ensure tasks are completed successfully and within target time-lines. Provide feedback and support of other NCE candidates including formulation development, process improvements, and clinical supply manufacturing. Participated in the building of a new in-house pharmaceutical development suite. Provided feedback with respect to containment of lab scale processing equipment. Researched and bought various lab scale finished drug product equipment for purchase and installation. Participated in writing NDA support documentation and NDA finished drug product sections in support of successful and timely submission. From August 2005 to October 2006 (1 year 3 months) Senior Development Scientist, Technical Support @ Managed the transfer of a solid dosage product to a new facility of a contract manufacturer. Team Leader of a interdepartmental and inter-company transfer group (three sites). Responsible for coordinating recurring team update meetings, maintenance of project time-lines, and completing the transfer within a projected budget. Responsible for all phases of the transfer including equipment installations, batch record reviews, protocol writing/reviews, equipment validation reviews, and process validation batches. Coordinated the successful transfer of a parenteral product from one manufacturing site to another site. Participated in the evaluation and selection of alternative manufacturing sites. Managed the product transfer that included equipment transfers, batch record reviews, protocol writing/reviews, equipment validation reviews, and process validation batches. Implemented process improvements during and after product transfer. From November 2003 to July 2005 (1 year 9 months) Research Scientist II @ Managed the overhaul of a pilot facility that included the installation of processing equipment. Managed a company directed clinical study for NDA submission. Implemented and managed long term processing improvements to the current product line. Acted as an R&D purchasing liaison for the Pharmaceutics Development Group. Responsible for the writing of SOP's and protocols to support clinical and process improvement projects. From February 2002 to October 2003 (1 year 9 months) Senior Formulation Scientist @ Designed an immediate release oral dosage form that incorporates the proprietary core technology (Accudep). Designed a controlled release dosage form that incorporates the proprietary core technology (Accudep). Conducted stability studies of finished dose forms using client compounds. Conducted cleaning qualification/validation of company proprietary equipment including the writing of protocols, SOP's, and cleaning procedures. Formulated and developed fast dissolving films for the AccudepTM core technology. Acted as a Team Leader in the finished dosage form group and cleaning validation group. Responsible for setting up formulation laboratories. Participated in the company's first clinical study of the controlled release dosage form. Participated in the Delsys Safety Team as a safety officer which includes conducting laboratory audits and actively enforcing all safety procedures. Participated in the 401k committee which revised and expanded the company 401k plan. From November 1998 to June 2001 (2 years 8 months) Research Pharmacist @ Solid dosage form development Designed and implemented a novel granulation technology. Developed wet granulation and direct compression formulas of analgesics, decongestants, and antacids. Designed a sustained release sphere dosage form. Conducted an in vivo - in vitro correlation study of the sustained release dose form using a contract manufacturer. Conduct scale-up operations of the spray dried product using a contract vendor. Design and implement statistical design studies and statistical analysis. Participate in the development of stability guidelines for testing new pharmaceutical formulations. Responsible for supervising and guiding one to three technicians. Evaluate and purchase new laboratory equipment to support ongoing and new projects. From October 1993 to October 1998 (5 years 1 month) Research Assistant @ Liquid suspension design and technology Develop and reformulate antacids and H2 antagonists. Scale-up and stability studies performed. Responsible for batch record writing, cleaning validations, and SOP report writing. Responsible for designing a prototype formulation of an aluminum free antacid suspension. Solid Dosage Form Drug Delivery Developed chewable and swallowable tablet dosage forms - antacids and H2 antagonists. Developed fast dissolving solid dosage form - H2 antagonist. Scale-up and stability studies performed. Conducted cleaning validations including the writing of protocols and reports. Responsible for batch record writing and review. All laboratory practices in accordance with cGMP. From May 1991 to October 1993 (2 years 6 months)

M.S., Pharmaceutics @ Temple University From 1995 to 2001 Bachelor of Science degree, Pharmacy @ Temple University From 1985 to 1990 Marc Karetny is skilled in: Excel, PowerPoint, Validation, Technology Transfer, Formulation Development, Pharmaceuticals, HPLC, GMP, Process Development, R&D, FDA, Quality Assurance, cGMP, Formulation, V&V