Manufacturing Associate Product Manager
Resume:
SOPHEAP SUN
Hagerstown, MD *****
********@*******.***
PROFESSSIONAL OBJECTIVE: Executive in Life Sciences, Product Management, Business Development, and GMP Processes.
TECHNICAL SKILLS:
Word Processing, Spread Sheets, Database, Microsoft Office, Visual Basics, Microsoft Project, Computer Graphics, Computer hardware and software design, troubleshooting network and hardware issues, Wireless technology, Large scale cell culture for clinical and commercial production, Delta V control automation, Allen Bradley/ Rockwell automation, Biotechnology equipment Validation and Cleaning Validation, DLIMS, Six Sigma, Trackwise, Servant Leadership, SAP, Situational Leadership, Project Management, Lean Manufacturing, Agile, IBIS, Product Management in Bioprocess. PROFESSIONAL EXPERIENCE:
PRESIDENT 2023 - Present
ADVANCE BIOLOGICS CONSULTING, Hagerstown, MD
Biotechnology and Bioprocess Consulting.
• Bringing Products to Market (Work flow management, Product Roadmap and Strategy, FMEA, Budgeting, Proposals)
• Marketing and Tradeshows (Product Marketing, Brochures, White papers, Technical Literature, Booth design)
• Automation (Allen Bradley and Delta-V, Facility Start-up)
• Validation and GMP operations (Cleaning & Equipment Validation, SAT, IQ, OQ, PQ, SOPs, Batch Records)
• Non-Conformance Investigations (Route Cause Analysis, CAPA, Training)
• Single-use Technologies (Bioreactors, Bags, Filters, connectors, Leachables & Extractables)
• Business Development
DIRECTOR, PRODUCT MANAGEMENT & INNOVATION 2021 – 2023 iBIO INC, Bryan, TX
Head of Product Management and Marketing. Core Team Lead for Innovation and Service Projects
• Manage Demand team as part of the Extended Leadership Team
• Develop new products and business cases for future products, ensuring FDA and GMP regulations
• Lead Marketing efforts and develop new marketing collateral
• Manage CDMO Projects: Proposals, Program Management, budgeting, planning, pricing, and customer meetings
• Develop customer relationships
• Establish company branding, market awareness, partnerships, and obtain VOC for new products
• Manage Development Projects for Catalog and Service offerings GLOBAL PRODUCT MANAGER 2017 - 2021
THERMO FISHER SCIENTIFIC, Frederick, MD
Lead the Cell Culture media and Serum Bioproduction business, including custom and EOM.
• Managed $200 Million in global business
• Developed tactical and strategic business plans to market and sell products
• Trained sales force and program management on products and process flow
• Initiated Commercial involvement in long term contracts and price negotiations
• Developed new business opportunities
• Resolved customer concerns and quality issues
• Interacted with customers to obtain VOC
• Developed new products and arrange for customer testing
• Managed supply allocations versus demand planning
• Managed cross functional team Projects for product/process improvement GLOBAL PRODUCT/PRODUCT LINE MANAGER, BIOPROCESS 2012 – 2017 EPPENDORF, Enfield, CT
Plan, organize, and manage the Sterilizable-In-Place product lines throughout the entire product life cycle to optimize profit and meet marketing, financial, and corporate growth objectives. Develop SIP business product line globally. Improve portfolio of products by 140%.
• Visit customer to develop relationships and close contracts with bioprocess sales teams.
• Redesign and managed portfolio of Sterilizable-In-Place bioreactors and fermenters (New Brunswick Product lines)
• Participate in overall product strategy, research and development requirements, development, and manufacturing coordination for current, new, and emerging products
• Coordinate technical product development, estimate of potential profit, and product roadmap.
• Manage product deviations, assist in Factory Acceptance Testing, and ensure the quality of product line
• Work with Engineering on product development objectives and schedules for all phases of product development
• Identify and evaluate new technologies and partnering opportunities for complementary third-party products to integrate and expand the company's product lines
• Conduct marketing analysis to develop product specifications and Product Briefs
• Conduct market research and identifies and tracks market trends in company's industry
• Coordinate and develop marketing, sales, engineering, and financial plans for product line
• Provide financial and technical justification for product selection, definition, and market launch of new products
• Provide forecasting information on products and accessories
• Participate in cross-functional development teams in all aspects of product life cycle, including inception, development, product launch, maintenance, and product phase-out
• Develop and maintain a prioritized list of customer and market requirements for product and UI software designs
• Manage media and publication content, and facilitate presentations at trade show and conferences
• Establish yearly pricing and discounts to each sales organization within Eppendorf and to the customer
• Support global sales organizations with technical expertise, customer presentations, and provide business cases
• Establish Product Configurators for each product line via SAP and U7, ensuring GMP, GAMP and ISO regulations
• Lead cross-functional teams in resolving problems related to production, design, or market requirements MANAGER, UPSTREAM CLINICAL SUPPLY 2011 - 2012
LAUREATE BIOPHARMACEUTICAL SERVICES, Princeton, NJ Managed Laureate’s GMP Cell Culture group to increase success rate from 30% to 99%
• Organized and structured schedules and personnel to improve success rate
• Implemented 5S and Kanban to organize materials and equipment
• Staffed and developed a fully functional second shift group
• Performed risk analysis on critical processes and equipment
• Improved bioreactors for both the pilot and GMP facility
• Eliminated outages through facility upgrades and redundant utility implementation
• Trained staff in non-conformance writing and CAPA resolution
• Consulted with clients to ensure success of projects
• Collaborated in cross functional teams to tackle quality concerns SENIOR MANUFACTURING ASSOCIATE/ PROJECT SUPERVISOR 2007 - 2011 MEDIMMUNE INC., Gaithersburg, MD
Perform start-up of a multi-product development manufacturing facility in Gaithersburg, MD
• Authored 100L, 500L, and 2000L bioreactor SDDS for validation of equipment.
• Managed Preventative Maintenance and Post Maintenance Projects.
• Managed introduction of new equipment.
• Executed PCS IOQ validation protocols for validation of the process controls system.
• Supervised the cell culture development manufacturing group.
• Resolved equipment issues related to start-up.
• Lead investigator for deviation resolution and product impact assessment.
• Managed calibration schedule for cell culture equipment.
• Participated in 5S and Lean initiatives.
• Led validation projects and introduction of new equipment.
• Trained personnel on troubleshooting problems related to equipment and controls.
• Rewired and reconfigure Rosemount pH and Mettler Toledo conductivity analyzers.
• Troubleshot and repaired bioreactor HMI (OIT) for Sartorius 500L bioreactor.
• Streamlined production process through segregation of materials an introduction of disposable items. MANUFACTURING ASSOCIATE III 2006 - 2007
UNITHER PHARMACEUTICALS INC, Silver Spring, MD
Performed start-up of a brand new biotechnology manufacturing facility in Silver Spring, Maryland.
• Authored SOPs and Batch Records while developing a brand new process.
• Manage Projects for new products, accessories, and third party products
• Commissioned and Validated new equipment such as: ABEC stainless steel bioreactor skids, Bellco glass bioreactors, CIP Skid, fixed tanks, incubators and shaker platforms, integrity testers, tubing welders, liquid nitrogen freezers, ViCell cell counters, POD filtration system.
• Troubleshot Allen Bradley controls and redesigned equipment faults during IOQ and PQ.
• Established new methods of sterile sampling of bioreactors.
• Implemented a new Millipore POD system for harvest filtration and utilized UF/DF filtration.
• Performed cleaning validation of all GMP equipment and reconfigured CIP recipes.
• Supervised cGMP campaigns.
• Performed Factory Acceptance Test and Site Acceptance Test on newly acquired New Brunswick bioreactors. MANUFACTURING ASSOCIATE II 2003 - 2006
HUMAN GENOME SCIENCE, Rockville, MD
Cultured and manufactured numerous clinical products from phase 2 and phase 3 cell culture of NSO cells. Authored and revised an abundant of SOPs and Batch Records. Resolved deviations and corrective actions through formal investigations. Project lead for facility expansion and process control development.
• Worked with process control to resolve PLC issues for Allen Bradley control software
• Supported and Troubleshot CEDEX, ViCell cell counter, Nova Bioprofile, Bayer Blood Gas Analyzer, YSI analyzers, 25L bioreactors, 200Lbioreactors, and 2000L Bioreactors.
• Validated equipment for cleaning processes
• Performed Start-Up of a 2000L Bioreactor Facility with equipment and PCS Commissioning, IQ, OQ, and PQ.
• Developed several SOPs and batch records for Phase 2 and Phase 3 mammalian cell culture procedures.
• Utilized Trackwise for deviation, corrective action, and investigation resolution.
• Led an integrated project execution of computerized process controls for the plant expansion. EXECUTIVE CONSULTANT 2000 - 2003
SUN CONSULTING INC., Danbury, CT
Coordinate and manage company business plan, marketing, funding. Provide computer networking services and consultation to small and medium size business in Fairfield County.
• Connected and wired offices with network cables, set up servers, workstations, and desktop PCs, troubleshot desktop problems, installed and configured software and hardware.
• Lead Project planning and integration to Migrate and upgrade from Lotus Notes 4.65 to R5.
• Installed, configured, and optimized SAP R3 3.1H and V4.5B Central Instance Server for Radiant. NETWORK OPERATIONS ADMINISTRATOR 1999 - 2000
PITNEY BOWES INC., Stamford, CT
Administer and troubleshoot Microsoft, Novell and Lotus Notes networks. Provide technical support and solutions to company-wide user base, both office and remote. Provide IBM global and mainframe administration nationwide.
• Led Y2K Team in division-wide computer technical upgrade of over 10,000 computers to give zero downtime. Software upgraded and supported include: Microsoft Office, Rumba, exceeds, Smarterm, Internet explorer, Lotus Notes, Remote Desktop32, Norton Antivirus, Novell Client, Windows NT, Windows 9x, and BIOS Updated.
• Provided 2nd level Lotus Notes 4.65 administration to over 20,000 end-users. Administered Lotus Notes R5.0.
• Troubleshot software and hardware problems on desktops and laptops with Windows based operating system. Backed up and restored 10 Novell/Win NT servers, and 24 Lotus Notes servers daily. TECHNICAL TRAINING:
• Delta V Troubleshooting– Emerson, Pittsburgh, PA
• SAP Materials Management – Fairfield University, Fairfield, CT
• Situational Leader and DISC profile training – Ken Blanchard Companies, San Diego, CA EDUCATION:
Executive Masters in Business Administration Degree Ken Blanchard College of Business, Grand Canyon University
• Corporate leadership and Servant leadership, Cumulative GPA: 4.0, Delta Mu Delta Honors Society Bachelor of Science Degree
Fairleigh Dickinson University, Teaneck, NJ
• University Honors Program, Graduated Summa Cum Laude
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