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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Heartwellville ST NWPalm Bay, FL Street Address
OBJECTIVE: Provide diverse managerial and technical knowledge to the Biotech/Medical/Management community.SKILLS: Over twelve years GLP experience in: Mycoplasma Testing Sterility Testing Tissue Culture Microbial Bioburden Testing Virus Testing Aseptic Technique Over sixteen years GLP/GMP experience in: Mouse Antibody Production Testing Hamster Antibody Testing Rat Antibody Production Testing General Safety Testing In Vivo Inapparent Virus Testing Additional skills: Over fifteen years of personnel management Interdepartmental communication GMP Document Control Systems: Trackwise, Labware, Sharepoint, Pilgrim Procurement / RFP experience Computer Skills (MS Word, Excel, Outlook, Skype, Teamworks, Smartsheet) Commercial Product Manufacturing Over 19 years of Equipment Validation (IQOQPQ) and Maximo experience Clinical Trial Product Manufacturing Over 27 years of client/customer communicationWORK EXPERIENCE:November 2021 June 2023 Senior Project Manager LSNE PCI Contract Manufacturing (Bedford, NH) Manages primarily Tier Ill (moderate to high complexity) projects for any North American site. Partners with a Program Manager when a project is in process validation to ensure a smooth transition. Provides project leadership, coordination, and support for multidisciplinary project teams. Maintains and develops client-business relationships. Ensures successful kick-off of projects and facilitates required technical transfer information gathering and maintenance. Ensures that the project schedule encompasses the project scope and associated details are accurately developed and maintained.Ensures equipment and materials are identified and purchased in a timely manner, as applicable. Ensures effective communication of project timelines, status and needs to all project team members and stakeholders through routine meetings and project reporting. Ensures meetings are documented with meeting minutes. Communicates timeline and scope change concerns to Management. Assess client requests and ensure scope changes are communicated to Sales for evaluating need for a change order, to management for escalation, and to other departments as necessary. Resolves client issues and escalate to PM Management as necessary. Ensures timely review and updates of documentation (MCP's, batch records, validation protocols, etc.) associated with each project. Ensures daily communication of operational status and issues to affected staff and management. Ensures samples are shipped to testing labs and results are provided to all relevant team members and stakeholders. Provides work direction and supervision to Customer Service Specialist(s), Project Coordinator(s), and Project Manager(s) as applicable. Analyzes and makes recommendations on Project Management policies and guidelines, as well as recommendations on training curricula. Supports project activities outside of core hours as necessary. Serves as coach and mentor to less experienced personnel as applicable.July 2019 November 2021 Sample Management Manager Charles River Labs (Shrewsbury, MA) Manage sample processing workflow: study setup, sample receipt, storage, shipment, and archive. Coordinate and schedule Sample Management services with support staff, external testing labs, and Business Clients. Primary point of contact for scientists, laboratory staff, and Business Clients (if required) with respect to Sample Management technical issues. Perform personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews. Assist in the development of short-and long-range operating objectives, organizational structure, staffing requirements and succession plans. Perform procurement processes to maintain equipment and consumable supplies. Manage the Stability Testing Program. Oversee the submission of client stability sample inventory. Manage the dispensing and/or shipment of stability samples per timepoint schedules in accordance to client protocols. Create, revise, and manage client stability protocols in compliance to GMP standards. Manage the Liquid Nitrogen Cryopreservation Repository Program. Oversee the submission of client cell bank and microbial bank submissions into CRL repository. Manage the inventory and shipment of client banks to clients per client protocol/requests.August 2017 July 2019 Project Manager Charles River Labs (Shrewsbury, MA) Assisted operations in the Bioanalytical Characterization Testing/Sample Processing/LN2 Cryopreservation Lab. Managed analytical equipment per GMP regulations. Managed sample processing operations for the analytical and liquid nitrogen lab. Managed procurement lab supply activities. Initiated appropriate corrective action to conform to GMP requirements. When required, developed improved procedures and implemented innovations. Actively involved in writing, implementing, revising and training SOPs in all aspects, including compliance with GMPs.May 2002 August 2017 Study Director / Project Manager - Charles River Labs (Wilmington, MA) Prepared and performed complex quality control audits of customer projects and ensured that ongoing studies were conducted accurately, efficiently and in compliance with any applicable regulatory guidelines. Performed Study Director or Associate Study Director duties for GLP assays performed for customers and other CRL divisions. Created and reviewed Study Protocols, reviewed Study data, compiled and reviewed Study Final Reports.Managed department laboratory equipment to ensure calibration and validations were performed per GMP guidelines.Initiated appropriate corrective action to achieve project goals. If required, developed and improved test procedures and implement innovations. Created and revised training SOPs in all aspects, including compliance with GLPs.Assisted in the transition of the laboratory from a GLP to a GMP testing facility.March 1989 May 2002 Laboratory Supervisor - Tufts University School of Veterinary Medicine (Grafton, MA) Prepared, reviewed and maintained relevant Standard Operating procedures (SOPs), Study Protocols, Batch Production Records (BPRs), Equipment Master Record Files (EMRs), and Training Records per FDA GLP Regulations. Coordinated, assisted, and monitored progress of all ongoing tests. Maintained Lab Equipment and Inventory. Recorded and catalogued all samples and reagents used in the lab. Prepared all Lab Reports for the Lab Director. Assisted in lab purchases, accounting and budgetary issues.Enhanced Sponsor / Client relations. Was a member of the Lab Safety Committee for the Grafton Campus, and the Quality Assurance Unit for Tufts School of Veterinary Medicine. Was the Building Liaison / Manager interacting with corporate sponsors located onsite. September 1987 March 1989 Research Laboratory Technician - Brigham and Women's Hospital (Boston, MA) Performed numerous molecular biology techniques. Worked with small animals. Euthanized research animals and extracted lung tissues.May 1983 September 1987 Research Scientist Aide / Crew Supervisor - University of Maine (Orono, ME) Collected and analyzed research data, performed explant Tissue Culture (summers), performed field work and experimental set-up. Generally cared (potted, watered) for Blueberry plants.EDUCATION: University of Maine at Orono, Orono, ME. Bachelor of Science Degree in Microbiology and Biochemistry (1987)PROFESSIONAL AFFILIATIONS:New England Regional Chapter of the Society of Quality Assurance (1994 - 2002) REFERENCES AVAILABLE UPON REQUEST |
