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Click here or scroll down to respond to this candidateCandidate's Name 1105 Hillsboro CircleKingsport, TN Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLELINKEDIN LINK AVAILABLEPROFESSIONAL EXPERIENCEUPM, Bristol, TNProject Manager Jul 2023 Nov2023 Managed commercial and non-commercial products Generated master documentation such as master batch records, specifications and protocols. Managed client forecasts and deliverables. Prepared, monitored and updated timelines. Managed client inventory for materials and components Provided relevant financial data on projects to the Finance Department to assist in appropriate revenue recognition and client invoicing.Lead team meetings both internal and externalPPD, Morrisville, NCAssociate Project Manager, Clinical Supplies June 2021-June2023 Supported supply chain for moderate complex global clinical trials. Ensures project/study activities are in compliance with company and client requirements. May act as representative and project lead for the department on less complex projects. Developed study specific plans for each assigned project. Mest with internal teams to coordinate efforts, provide recommendations and risks, and update project reports/spreadsheets. Ensured fluent communication and interaction between internal departments in order to avoid obstacles during the course of the study. Integrated all clinical supply activities into the supply chain to support project logistics strategy. Participated in ongoing training on new regulations. UPM, Bristol, TNProject Manager Sept 2017- May 2021 Managed commercial and non-commercial products Generated master documentation such as master batch records, specifications and protocols. Managed client forecasts and deliverables. Prepared, monitored and updated timelines. Candidate's Name 1105 Hillsboro CircleKingsport, TN 37660PHONE NUMBER AVAILABLEEMAIL AVAILABLELINKEDIN LINK AVAILABLE Managed client inventory for materials and components Provided relevant financial data on projects to the Finance Department to assist in appropriate revenue recognition and client invoicing. Lead team meetings both internal and external.Alcami Corporation (formerly AAIPharma Services / Cambridge Major Labs) Business Analyst Sept 2016-Sept 2017 Create sales order entries in the ERP system, ensuring that the data entry is timely and accurate. Manage milestone payment requirements in client contracts, ensuring they are invoiced on time and that they are adequate to cover all work performed. Close out projects with operations personnel to ensure all incurred costs are charged to the appropriate projects. Create invoices for billable work performed and monitor client deposits based on contract requirements. Manage the monthly and annual sales forecast and corresponding reporting. Liaise between the business analysis team and finance to ensure revenue is being captured in accordance with GAAP. Partner with business team to develop short and long-term revenue forecasts. Report on project profitability to management. Assist finance team with month end close. Ensure vendor invoices are charged to the appropriate project. Assist with year-end financial audit as well as ad-hoc requests. Alcami Corporation (formerly AAIPharma Services / Cambridge Major Labs) Project Coordinator Oct 2014-Oct 2016 Planned, directed and coordinated pharmaceutical manufacturing and packaging projects Managed >20 clinical programs including oral solid dose and parenteral Overseen > 5 later phase projects through registration, validation, product launch and commercial supply Coordinated clinical distribution and commercial product launches into US and EU. Demonstrated expertise in clinical packaging design and clinical labeling Drive project success by managing internal team deliverables and follow up on action items Acknowledged by colleagues and clients the ability to alleviate issues before difficulties Established the ability to multi-task and still focus on details Generate project documentation including master batch records, specifications, and protocols Deliver excellent documentation to support execution of projects Serve as priCandidate's Name 1105 Hillsboro CircleKingsport, TN 37660PHONE NUMBER AVAILABLEEMAIL AVAILABLELINKEDIN LINK AVAILABLE Control work activities within the scope of the service agreement when possible and interpret customer needs to aid in quotation completion.AAIPharma Services / Cambridge Major LabsLaboratory Technician May 2012-October 2014 Performed analytical routine and non-routine testing to support pharmaceutical development and pharmaceutical manufacturing including Assay by HPLC, Karl Fischer, Dissolution, TLC, Mass Spec and pH. Performed Method Development and Method Validation to support client needs Wrote and reviewed Test Procedures and Method Validation Reports Recognized by colleagues the ability to prioritize and organize routine work with minimum supervision Deliver excellent documentation in laboratory notebooks Acquired general knowledge of current GMP practices and regulatory guidelines AAIPharma ServicesPackaging Technician April 2011-May 2012 Prepared documentation for packaging operation including packaging batch records, logbooks, forms and protocols in accordance with SOPs and client requirements. Performed quality control inspections of product for pharmaceutical packaging and labeling processes.CEPCOAdministrative Assistant October 2007-February 2010 Planned and prepared documents and attending client meetings Prepared meeting minutes to support client needs Provide support activities for the unit such as assisting and resolving problems Review and control of incoming and outgoing correspondence, and follow-up on operational commitments. Provide support to management in company meetings with clients EDUCATIONBachelors of Science, Business Administration, Summa Cum Laude Candidate's Name 1105 Hillsboro CircleKingsport, TN 37660PHONE NUMBER AVAILABLEEMAIL AVAILABLELINKEDIN LINK AVAILABLECapella University Dec 2020Associates Degree, Associates in Science June 2001 Carteret CommunitySKILLSMicrosoft Office, Microsoft Word, Microsoft Excel, PowerPoint, Microsoft Dynamics AX, Master Control, ELN, Trackwise, Veva Vault, Nitro Pro, Documentum, Clarity RELEVANT COURSESUniversity of North Carolina at UNCW August 2002Organic Chemistry 211 & 212, Spanish I Statistics 215, Genetics 335, Ecology 366 |
