SUMMARY

• 10+ years in R&D Pharmaceutical Industry.
• 8+ years in Pharmaceutical Global Project Management (Global PMO)
• Experienced with of all GMP, cGMP ISO, GLP, ISO and Global FDA, EU, JP, & Latin America regulations and audits.
• Partners with Global Sr. Managers, Directors, VPs & CEOs to execute clinical supply management projects offshore and on shore.
• Experienced in various LIMS systems such as Starlims, Labvantage, Labware, Agile, Scrum, Oracle, SDL, SDLC and more.
• Effectively manage various cross team members such as engineers, MDs, scientist, Medical Affairs, and other experts to make sure that projects are running smoothly on time and budget.
• Experience with all Global matrix regulatory medical affairs, regulations and quality documentation, process validation, QC, for in - vitro diagnostic medical device and biopharmaceuticals for more than 10 years.
• Schedule management, cost/budget management, quality management, resource management, risk management, communications management, contract management, and system integration management.
• Address clients needs carefully to analyze their financial goals and design financial plans to suit their business needs.
• Familiarity with budget tracking and portfolio financial planning and analysis
• Work closely with the plant lab SMEs to implement an automated laboratory testing platform for Raw Materials and Finished Good testing, based on a defined standard work process to drive projects goals.
• Effectively manage the engineers, doctors, researchers, and other experts to make sure that medical trials are running smoothly on time and budget.
• Creating status reports for management, ensuring compliance with regulatory bodies, managing timelines, evaluating the project risks, specifying project plans, establishing work schedules, keeping meticulous research records, and gathering project resources.
• Working experience in production of different dosage forms like Tablets, Capsules, Ointments and Liquids.
• Experience with test method validation and verification process for 90+ assays & 10+ diagnostic instrument types.
• Experience with 510k and reagent replacements FDA submittals.
• Experience with data management, data analytics, root cause analysis and project management.
• Perform various routine data analytical studies as required by client submissions.

TECHNICAL SKILLS

• MS Project
• Planisware
• Microsoft Office Suite including Access
• Sharepoint and Visio
• Excel
• Adobe/Acrobat Software and all Abbott in house softwares/statistics data analysis.
• AutoCAD
• HPLC
• LCMS
• GC
• GCMS
• ICP
• MS
• IR
• UV
• Clinical Chemistry analyzers
• Immunoassay Chemistry analyzers: Architect C4000 C8000 C1600 i1000SR i2000SR i4000SR ci4100 ci8200 ci16200

PROFESSIONAL EXPERIENCE

Confidential, Deerfield IL

Sr. Project Manager

Responsibilities:

• Partners with Global Sr. Managers/Directors to execute clinical supply management projects.
• Spearheaded the development of the Global Program Management Office; defined project management processes, including those related to requirements management, change control, and user acceptance testing. And utilize global project office management as per customer expectations.
• Managed projects with varying levels of complexity and identified and mitigated potential risks; developed requirements, managed change control, and tracked schedules and cost performance while ensuring project activities aligned with business objectives using Global PMO.
• Works in partnership with the Quality and Operations functions to ensure clear communication of customer requirements and capabilities in order to successfully complete projects of all sizes within time, scope and quality requirements.
• Address clients needs carefully to analyze their financial goals and design financial plans to suit their business needs.
• Familiarity with budget tracking and portfolio financial planning and analysis
• In conjunction with Sr. Managers/Directors support multiple customer projects simultaneously to meet customer and expectations.
• Ensure project deliverables are on time, within budget and at high standards of quality.
• Execute the project according to the project plan.
• Experience with data management, data analytics, and project management.
• Responsible for timely completion of Project milestones by tracking Product development and Launch activities for global projects.
• Responsible for documenting and tracking Minutes / Tracking all global project activities. Accountable for updating Planisware/Impact updates on new products and conduct regular project review meetings to monitor projects progress (Minutes of meeting, Regular Developmental updates, Project Timeline, Project Tracker) involving I&D stakeholder groups .
• Liaise with cross-functional teams like RA, Medical, BD, IPR, QA, and Supply Chain to ensure smooth execution of the projects Manage Project Portfolio Risk through identification of early warning signals, assessment & on time escalation.
• Manage project data/information and provide periodic updates to project team and all stakeholders Closely work with I&D scientists (formulators and analysts) to manage and track their project requirements, roadblocks and bring it up to management attention (if applicable).
• Involved in the (CTSM) Program to produce high-performance trade show and event marketing programs with high measureable results. Monitor the progress of the project and make adjustments as necessary to ensure the successful completion of the project.
• Establish a communication schedule to update appropriate staff, leadership and customers.
• Evaluate the outcomes of the project as established during the planning phase.
• Generate material specifications and purchase orders.
• Generate study specific logistics protocols.
• Manage customer distribution issues.
• Support development of manufacturing instructions for packaging jobs.
• Develop and utilize company tools to maximize business efficiency.
• May draft customer proposal under the guidance of Sr. Mangers/Directors
• Represent the Company in various meetings with outside clients, agencies companies and consultants.
• Perform various other duties from time to time to support Company business objectives.
• Ensure adherence to appropriate policies and procedures.
• Work closely with the plant lab SMEs to implement an automated laboratory testing platform for Raw Materials and Finished Good testing, based on a defined standard work process.
• Build an excellent understanding of a Laboratory Information Management (LIMS) system and plant laboratory processes.
• Own individual site issues and action items on behalf of the global project team create communication messages for both written and oral for varied site situations.
• Demonstrate a strong understanding of the project guidelines and principles to educate site SMES and answer questions.
• Demonstrate knowledge of application functionality and serve as a key global LIMS system process expert.
• Work closely with the site and global team members to deliver on time and budget.
• Define and articulate issues for escalation to project team manager.
• Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project.
• Identify and understand issues that may impact the site schedule.
• Use technical tools for (queries, process maps, etc.) for problem resolution.
• Demonstrated experience in a Chemistry and / or Micro testing lab executing test specifications with lab instrumentation.
• Demonstrated lab experience of identifying continuous improvement opportunities.
• Accountable for acquiring and then demonstrating solid laboratory business and LIMS knowledge.
• Possess knowledge of the System Development Lifecycle and implementation processes.
• Demonstrate Business Analysis techniques to propose solutions for varied issues.
• Provide strategic direction and methodology for the Communication and Change Management approach for global Purchasing and Supply Management
• Promote the Purchasing and Supply Management culture through communication and programs
• Own and deliver against a comprehensive communication plan for internal communications; ensure messages are being delivered to the right audience at the right time, in a consistent and engaging format.
• Leverage change management methodology and apply as appropriate for the business environment, focusing on execution and impact.
• Lead process improvement and optimization initiatives for the organization.
• Provide strategic direction and methodology for the Communication and Change Management approach for global Purchasing and Supply Management
• Promote the Purchasing and Supply Management culture through communication and programs
• Own and deliver against a comprehensive communication plan for internal communications; ensure messages are being delivered to the right audience at the right time, in a consistent and engaging format.
• Leverage change management methodology and apply as appropriate for the business environment, focusing on execution and impact.
• Lead process improvement and optimization initiatives for the organization.
• Ability to learn the concepts of lean principle standard work and apply continuous improvement to create one method of working and templates used across sites.
• Strong communication skills (verbal/written/listening).
• Solid business knowledge, with a preference for Quality and/or manufacturing systems experiences.
• Accountable for strong knowledge of the standard deployment processes and demonstrate LIMS application efficiency.
• Strong interpersonal skills and ability to manage.
• Schedule management, cost/budget management, quality management, resource management, risk management, communications management, contract management, and system integration management.
• Developed and utilized Structure Product Labeling format (SPL) and requirements for legacy and Physician Labeling Rule (PLR) labels
• Demonstrate understanding of Electronic Document Management Systems (EDMS) to a sufficient level to support version control and archival of labeling documentation
• Experienced in developing company core data sheets and safety (CCDSs).
• Understanding of pharmaceutical drug development and global regulations pertaining to labeling.
• Work closely with global guidance to labeling, drug development, and commercialization of prescription medicines.
• Experienced in EU and US labeling requirements/ guidance and familiarity with US legacy and PLR-formatted labeling.
• Ability to communicate and resolve issues during labeling reviews and discussions.

Confidential, Lake County IL

Sr. Project Manager

Responsibilities:

• Spearheaded the development of the Global Program Management Office; defined project management processes, including those related to requirements management, change control, and user acceptance testing. And utilize global project office management as per customer expectations.
• Managed projects with varying levels of complexity and identified and mitigated potential risks; developed requirements, managed change control, and tracked schedules and cost performance while ensuring project activities aligned with business objectives using Global PMO.
• Design experiment and test schemes, analyze data, write protocols and reports and present results to a cross-functional team.
• Experience with data management, data analytics, and project management.
• Developed formulations for the liquid dosages forms like solutions, suspensions, emulsions, micro-emulsions & surfactants.
• Address clients needs carefully to analyze their financial goals and design financial plans to suit their business needs.
• Familiarity with budget tracking and portfolio financial planning and analysis
• Analyzed the developed formulations using various analytical methods for liquid and semi-solid dosage forms.
• Demonstrate strong problem solving and analytical skills.
• Follow all GMP, ISO, and FDA regulations and audits.
• Comply with all policies, established procedures, and regulations related to clinical research.
• Participate in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study.
• Assist Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study. Expert in the following Clinical Chemistry analyzers & Immunoassay Chemistry analyzers: Architect C4000, C8000, C1600, i1000SR, i2000SR, i4000SR, ci4100, ci8200, ci16200.
• Experience with use of m-power software.
• Experienced in working with vitro assays including assay development, optimization, and troubleshooting part of assay development group.
• Develop and write new methodologies for new testing procedures/method validations.
• Experience in writing formulas and procedural based experiments.
• Knowledge of regulations and standards affecting documentation and system requirements. Knowledge of cGMPs and all biopharmaceutical regulatory affairs.
• Was responsible for the final release of technical and quality documents to assure the information was correct, with the proper approvals attained, to assure all document references would pass the required FDA standards of regulation.
• Made sure there were no undetected errors, since projects at this level had the potential to cause significant negative impact in the areas of compliance, regulatory affairs and FDA requirements.
• Follow all GMP, ISO, and FDA regulations and audits. Test method validations.
• JMP software experience, SAS experience, Minitab experience
• Was responsible for the final release of technical and quality documents to assure the information was correct, with the proper approvals attained, to assure all document references would pass the required FDA standards of regulation.
• Experience in over 160+ assays and relevant in vitro models passed through the FDA taken from phase 1 through phase 6.
• Experience with new drug registrations and applications for all FDA regulatory affairs.
• Experience working with drug prescribing information (PI, SmPC) and scientific data and all submission QA reviews.
• Worked collaboratively among a team of high throughput screening scientists and therapeutic area biologists to develop, optimize and execute in vitro plate-based assays
• Developed proficiency with multiple assay formats, optimizing assay efficiency and reliability while minimizing cost.
• Worked closely with senior scientists to develop and optimize complex biology/phenotypic assays using primary cells and stem cells.
• Knowledge with basic calibration and test measurement, experience with IQ, OQ, PQ.
• Knowledge and experience with PET radiopharmaceuticals mainly with 4 carbon-11, nitrogen-13, oxygen-15, and fluorine-18.
• Developed and utilized Structure Product Labeling format (SPL) and requirements for legacy and Physician Labeling Rule (PLR) labels
• Demonstrate understanding of Electronic Document Management Systems (EDMS) to a sufficient level to support version control and archival of labeling documentation
• Experienced in developing company core data sheets and safety (CCDSs).
• Understanding of pharmaceutical drug development and global regulations pertaining to labeling.
• Work closely with global guidance to labeling, drug development, and commercialization of prescription medicines.
• Experienced in EU and US labeling requirements/ guidance and familiarity with US legacy and PLR-formatted labeling.
• Ability to communicate and resolve issues during labeling reviews and discussions.

Confidential, Lincolnshire, IL

R&D Project Manager

Responsibilities:

• HPLC Chromatography, UV Spectroscopy, GC chromatography, GC-MS (Gas Chromatography Mass Spectrometry), IR spectroscopy
• ICP-MS Inductively Coupled Plasma Mass Spectrometry, ICH/ICH EP/ICH JP
• Experience with API’s for Third Party Regulatory Affairs Compliance
• All USP, NF, EP, FCC, ACS compendia testing. Some JP compendia testing, Assay Testing
• Physiochemical Plastics Testing, Heavy Metals I & II Testing, Arsenic I & II Testing
• Glass Surface, Glass Grains, Glass Arsenic and Etching Testing. Autoclave Preparation
• Acid/Base Titrations. General Identification of USP and EP Reagent Testing
• Sodium, Acetate, Ammonium, Chloride, Sulfate, Iron and various many USP limit reagent testing
• Container Permeations Liquids and solids Testing
• Residue on Ignition Testing, Loss on Drying Testing, Calibration of pipettes, Calibration of PH meters/PH
• Water & Nitrates Testing, Volumetric preparation of reagents/standards
• Use of all wet and dry laboratory equipment. Experience with use of m-power software.In SGS: Experience in the formulation development includes, we ran studies to dissolve & reformulate some of the following& more examples:
• Capsules -gengraf generic. Soft gels- Confidential gelatin. Semi-solids - Confidential / Confidential products
• Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately effective manner.
• Ensure that all client requests for information pertaining to analytical testing are passed on to appropriate company personnel in a timely and effective manner.
• Perform various routine data analytical studies as required by client submissions. Duties here include preparation for testing by using good time management skills for each assigned task, such as confirming availability of resources (standards, equipment, etc.) and adequacy of testing documentation, proper application of test procedures, proper technique for data capture and recording, and preparation of the final report of analysis.
• Provide crucial support to other Analysts in the conduct of their studies.
• Maintain thorough knowledge and understanding of all general SOPs pertaining to the Analytical Services Laboratory.
• Maintain thorough knowledge and understanding of GMP/GLP and ISO requirements as these pertain to work performed in the Analytical Services Laboratory.

Confidential -Lincolnwood, IL

Senior R&D Scientist

Responsibilities:

• Utilizes chemicals, chemical compounds and chemical processes to create new products and technologies.
• Mixes different chemicals or polymers together to discover the results and chemical properties.
• Utilize computerized databases that contain searchable lists of chemicals and chemical reactions.
• Research to brainstorm ideas for new products.
• Performs laboratory tests such as pH, fluoride, viscosity, specific gravity, color, appearance, or any other lab tests to set specifications for product. Tests raw materials for specific quality attributes.