Project Manager
Resume:
Ariel N. Attimy
***** ****** ******* **. ***.**
Hagerstown, Maryland 21742
*******@*****.***
Professional Summary:
Accomplished and energetic CMC Project Manager with a solid history of achievement in quality control, research and cell therapy. Core Competencies include quality decision making, innovative thinking and action orientation as well as excellent communication and time management skills. Handles tasks with accuracy and efficiency.
SKILLS:
Time Management
Critical Thinking
Attention to detail
Customer Focus
Written and Oral Communication
Integrity
Diplomacy
Strong Work Ethics
EXPERIENCE:
Precigen Inc.
CMC Project Manager Apr2018-Present
Participate in team effort to establish early product definition, including process development, formulation, analytical development and delivery
Develop and maintain detailed and comprehensive project plans and budgets for CMC programs
Identify best in class contract manufacturing organizations that are qualified to perform technology transfer, process development and GMP manufacture of biologics
Serve as principle point of contact with CMOs, establish appropriate contract documentation and coordinate all team meetings and discussions
Prepare and execute technology transfers with CMOs and contract testing laboratories
Manage the development of process improvements and scale-up efforts and supervise CMOs in GMP manufacture and testing of clinical trial materials.
Provide troubleshooting support as needed
Along with QC and QA, assure adherence to Quality Agreements with CMOs
Prepare CMC sections for regulatory submissions (IND, Annual Reports and BLA), invention disclosures, progress reports and publications.
Present updates to project teams on development and manufacturing activities
Maintain a high level of knowledge in gene and cell therapy, particularly in the field of CAR-T product development and manufacturing
Collaborate with other internal Precigen departments with an eye toward future commercialization of biological products
Serve as an internal resource for Precigen R&D regarding manufacturing science, analytical, formulation and delivery issues
Lonza Inc.
QC Analyst II (QC Cell Therapy Bioservices) September 2015-Apr2018
Performed Quality Control biological/cell based testing of Cell Therapy, Clonetics and Poietics release and stability test according to Current Good Manufacturing Practices (cGMPs). Typical test methods performed, include proliferation, flow cytometry(which included surface and intracellular staining), ELISA(enzyme-linked immunosorbent assay), cell counts (manual and automated machines), cytochemical and immunofluorescence microscopy
Participated in technology transfer activities, which includes training on new methodology, setup of new equipment and review of method SOPs
Reported test results, maintain raw data and accurate laboratory records in accordance with applicable SOPs
Initiated Out of Specification (OOS) and deviation investigations as needed to address non-conformances in the lab, using Trackwise
Ordered supplies and reagents through SAP (Systems-Application-Products) ordering system
Performed general lab and equipment maintenance duties
Assisted with drafts, edits and revisions of SOPs
Department Hazardous Material Coordinator
Operation Technician II (Research Cells) August 2010- September 2015
Performed isolations of specific cell types from human and animal tissues in a Laminar Flow Biological Safety Cabinet
Performed isolations of specific cell types from human cord blood, human bone marrow and human peripheral blood in a Laminar Flow Biological Safety Cabinet
Manufactured Osteoclast Precursors
Manufactured Osteoassay Plates (Human Bone Plates)
Maintained feeds, passages and harvest cell cultures
Observed cell culture through the microscope to evaluate the confluence and morphology
Prepared media and other materials used in production processes
Stained FACS (fluorescence-activated cell sorting) samples from specific cell isolations
Made and packed tissue kits
Assisted in maintaining lab in good working order, which includes operation and maintenance of equipment (balances, centrifuges, microscopes, cryomed freezer and incubators)
Performed general laboratory cleaning
Maintained records as required, including cleaning logs
Maintained lab inventory
Performed SAP (Systems-Application-Products) work by closing out jobs associated with that specific lot, as well as ordering material for the lab
Core Technician I-II (Cell Therapy) October 2007- August 2010
Participated in aseptic processing of clinical grade product according to cGMPs
Processed cell cultures aseptically in the Laminar Flow Biological Safety Cabinet, which included feeds, passages and harvests
Observed cell culture through the microscope to evaluate the confluence and morphology
Followed SOP’s and batch records detailing process for cell therapy products
SAP ordering, other computer functions
Performed environmental monitoring
Department Training Coordinator for SOP’s
Drafted, edited and revised SOP’s and batch records to support cell therapy products and procedures
Assisted with the planning, requisition, and return of production materials
EDUCATION:
The Pennsylvania State University, University Park, PA
Bachelor of Science in Life Science, May 2007
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