MARK EINZIGER

* *********** *****

Manalapan New Jersey 07726

Tel: 732-***-****

Cell 732-***-****

Email: adty4t@r.postjobfree.com

SUMMARY

Aggressive resourceful, Take-Charge Program Manager with comprehensive skills in the administration and day-to- day supervision of technical and support systems. Managing product development group for medical and non-medical devices.

Specific areas of experience:

• Pharmaceutical Development Project Management

• First to File Project Management

• Solid Dosage delivery system experience

• Soft gel delivery system experience

• Class 1 Medical Devices

• DEA Control Substances (Schedule 1 & 3)

• cGMP environment

• Quality Assurance

• Product Introduction

• Scheduling and Planning

PROFESSIONAL EXPERIENCE

CMIC CMO USA (Full-time Cranbury New Jersey Dec 2021 – Dec 2022 Chief Business Development Officer

Built Business Development team to source out new contract development projects

• Hired experienced pharmaceutical representatives for team

• Worked with US and Japanese marketing team to develop marketing strategy plan for increasing company revenue

o Contributed content for published print advertisement o Created marketing plan for pharmaceutical trade shows o Worked with marketing team to create copy for increasing company offering

• Implemented quoting structure for new projects

• Worked with formulation, analytical and production group to update pricing structure for quoting

• Represented CMIC at trade shows including DCAT

• Prepared detailed weekly and monthly reports CMIC USA and parent company CCJ in Japan Aug 2019 – Dec 2021

Associate Dir of Project Management

Develop and build timeline for the implementation and launch pharmaceutical drug development, clinical trials filing and launch

• Build and Managed Project Management time, developed matrix to control on time delivery to customer.

• Created MS Project Timelines

• Restructure quotations model for completion of project

• Control financial budget for project

• Develop strategic planning and aggregate project scheduling for timely completion of customer projects

• Generated change request for budget adjustments

• Monitored billing of project contract employees

• Maintain project revenues to ensure timely completion of project tasks as per the timeline

• Generated RAID reports

Mark Einziger Page 2

Bristol Meyer-Squibb (Contractor) Lawrenceville New Jersey March 2018 – July 2019 Sr. Project Manager

• Develop and build timeline for the implementation and launch of IT Reagent Inventory and Ordering (RIO) platform

• Manage multi-site team to meet BMS schedule for companywide Go-Live of RIO project

• Manager multi-discipline cross-functional teams

• Control financial budget for project

• Generated change request for budget adjustments

• Monitored billing of project contract employees

• Worked directly with outside contractors quotes

• Maintain project revenues to ensure timely completion of project tasks

• Approve vendors invoicing

Ethicon (J&J company) (Contractor) Somerville New Jersey Jan 2018 - Mar 2018

• Develop and build timeline for the implementation for Compound Medical Device

• Coordinate transfer of timeline to J&J PMO group Sun Pharma (Contractor) Princeton New Jersey Jan 2017 - Dec 2017 Sr. Project Manager

• Develop and build timeline for the implementation, FDA filing and launch of 505b(2) genetic Eye Drops

• Manage multi-site team and third party contractors and development teams

• Monitor matrix on meeting project schedule

Catalent Pharma Solutions formerly Cardinal Health, Somerset, New Jersey 2005 - 2017

•

Sr. Project Manager

• Manager external and internal Pharmaceutical development projects at major CMO

• Manager multi-discipline cross-functional teams, from project inception to technical transfer to production.

• Prepare project proposals and plans preliminary timeframe, funding limitations, procedures for accomplishing project, staffing requirements for internal Catalent programs.

• Develop strategic planning and aggregate project scheduling for timely completion of customer projects

• Maintain project revenues to ensure timely completion of project tasks

• Develop project timelines on twelve current project, with revenue of $130K – $2.0MM per project

• Lead teams in the launch of Commercial products including Vivus Qsymia Beads in Hard Shell Capsule, J&J’s Monistat-3, K-Y LiquiBead (Value $4,000,000/year), Insys Generic Marinol softgel capsules (Value

$9,000,000/year) and Actavis First to File (Ethyl Icosapentate Softgels)

• Main contact with customer both internal and external, setup and conduct weekly update meeting on all active projects. Responsible for maintaining meeting minutes and action items CHURCH & DWIGHT CO., INC., Princeton, New Jersey 1997 – 2005 Program Manager

Manage commercialization and new product development group for Specialty Product Division.

• Hemodialysis products both Commercial and Professional product lines

• Directed both medical and non-medical product development.

• Supervised all technical aspects for sodium bicarbonate in the dialysis, pool, and spa industry.

• Devised innovative delivery systems for chemical formulations use in residential and commercial pools.

• Set-up in-house and field pool studies, including stabilize studies and consumer test pan Mark Einziger Page 3

RHODIA formally RHONE POULENC, Cranbury, New Jersey 1993 – 1997 Senior Research Scientist

Bench and field scientist responsible for the development, testing, piloting and production of core company products.

Personal Care

• Formulation of Shampoos, Conditioners, Baby Care products, Moisturizing Lotions, Hand and Body Lotions, Sun Blocks, Styling Gel and, Polyvinyl Masks.

• Four years’ experience with emulsion formulations and stability studies.

• Designed and developed process lines for production operations.

• Daily tech service contact with customers, delivering production ready formulations. HI&I

• Formulations included liquid hand dish detergent

• Liquid laundry detergent and powder detergents formulations. Including reformulation of current granular laundry detergent without APE’s.

• Developed granulation viability for surfactant blends.

• I was in charge of purchasing pilot plant equipment for wash lab including Witte Fluid Bed dryers, single screw doom extruders, granulating equipment, and process milling units. Agricultural Group

• Formulation of spray dried adjuvants, WDG’s, EC, SC, WP, Aqueous and Non-aqueous suspensions, as well as manufacturing process technology both at pilot plant and production levels. EDUCATION

BA University of Dayton, Dayton Ohio, 1977

United States Patents

“Pool Buffering Composition and Method of Use”, U.S. Patent No. 6,054,056

“Nonionic Surfactant with Enhanced Aqueous Dissolution Rates”, U.S.Patent No. 5,567,475

“Dry Speadable Water Dispersible Granule Compositions”, U.S. No. 5,759,943

“The Application of Dry Spreadable Water Dispersible Granule Compositions”, U.S. Patent No. 5,738,623

“Enhancement of Soil Release with Gemini Surfactants”, U.S. Patent No. 5,922,663

“Stable Aqueous Fertilizer Composition Concentrate Comprising Potassium”, U.S. Patent No. 5,863,861

“Solid Surfactant Compositions with Decreased Dissolution Rates and Process for Producing Same”, U.S. Patent Pending, Filed 12//95

“Solid Surfactant Compositions with Enhanced Dissolution Rates and Process for Producing Same”, U.S. Patent Pending, Filed 12//95

“Liquid Hand Dish Detergent Composition”, U.S. Patent No. 5,906,972

“Sodium Bicarbonate/Sodium Chloride Micronized Slurry”, U.S. Patent No. 7,205,000

“Micron Sized Bicarbonate Particles and Slurrys Containing the Same”, U.S. Patent No. 7,435,426

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