Project Manager Engineer
Resume:
Ross Dikas
Grafton, MA
******@*******.***
Summary of Qualifications:
Multi-talented, versatile, cross-functional senior professional with 16 plus years of diverse functional experience in: GMP manufacturing operations, leadership in project management, process and product development and supervision of design/constructing biopharma/process engineering capital projects. Outstanding ability to build and maintain constructive working relationships, providing influential communication to improve process flow along with decisiveness, organizational skills, and adept at managing multiple teams productively to provide exceptional craftsmanship, while meeting critical deadlines with enthusiasm. Manage multiple projects of all sizes and budgets. Proven ability to lead and influence data-driven strategy planning and implementation. Excellent business acumen with demonstrated ability to align teams to corporate strategy to achieve program and business objectives.
Professional Experience:
Biopharmaceutical Consultant, Boston, MA 2013 – Present
Responsible for the management of all daily program activities (cGMP manufacturing, validation, process development and regulatory strategies) for 2 drug products and managing overall project planning, cross-functional program meetings, and helping teams navigate decision-making and governance processes CMC Program Manager, Shire 2016 – Present
Execute 3 capital projects and validation master plan associated with project execution shutdown management, manufacturing coordination meetings, verify production schedules, start-up activities and management of change documentation Senior Project Engineer, Merck Research Laboratories, 2015 – 2016
Managed coordination of construction, commissioning, and qualification schedule requirements with design engineering team of newly approved FDA product Project Manager, Bristol Myers Squibb, 2015
Coordinated technology transfer of 2 products, process fit analysis, process validation, and process troubleshooting to drug substance manufacturing activities at external facilities globally Scientist IV, Alexion, 2015
Coordinated fabrication, procurement, installation, engineering start-up, and validation activities of 6 AKTA bioprocess skids, 3 Axichrom Columns, including documentation of IQ/OQ protocols and test executions Downstream Process Engineer, Novo Nordisk, 2014 – 2015
Managed 10 change control processes and validation strategy to ensure conscious scope, schedule, technical specifications, test plans, project plans, and resource plans with Engineering, Manufacturing and Regulatory Affairs Validation Engineer III, EMD Millipore, 2014
Reviewed and modified standard operating procedures (SOPs) & validation documents for equipment supporting downstream operations Senior Engineer, Hyde Engineering + Consulting, 2013
Additional Experience:
Pall Life Sciences, Westborough, MA 2012 – 2013
Project Manager/Bioprocess Engineer
Provided engineering group with technical expertise and project support during design, build, and qualification phases (IQ, OQ, PQ, SFAT, FAT, and SAT) of 6 filtration and 3 purification bioprocess systems
Led development, approval, training, and communication of new products/product changes, developed, managed, track progress and updated project plan to meet approved requirements/scope defined
Genzyme, Framingham, MA 2010 – 2012
Manufacturing Supervisor
Supervised 5 manufacturing technicians and leading operations of 6 bioreactors, all related equipment and systems necessary to CIP, SIP and maintain equipment supporting 3 drug products
Performed Batch Record review and approval and change control ownership, coordinated/track/drove closure of CAPAs and deviations.
Lonza, Hopkinton, MA 2008 – 2010
Manufacturing Supervisor
Led start-up, validation and operation of a $125 million dollar cGMP Production Facility Expansion Project, participated in and approved the interviewing, hiring, and training of department employees and conducted performance evaluation for direct reports
Supervision and support of 10-15 manufacturing associates in operation of all upstream, downstream and support equipment (fermenters, centrifuges, filtration skids, chromatography skids, process vessels)
Johnson & Johnson/Centocor, Spring House, PA 2006 – 2008
Associate Scientist II
Development and execution of multiple aspects of protein purification, including chromatography (affinity, ion exchange and hydrophobic interaction), filtration and membrane separations (TFF, difiltration, viral filtration, depth filtration)
Managed and executed technology transfer, project planning, campaign execution for 10 downstream processes, performed deviations for corrective action and preventive action (CAPA) activities
Amgen, West Greenwich, RI 2003 – 2006
Senior Manufacturing Associate
Operation of purification equipment (columns and filtration skids), conducted training for new employees; improved productivity initiating systems for accountability
Instituted effective training programs leading to decrease in deviations 20%, performed in-process review of manufacturing procedures/batch records and automated reports
Regeneron Pharmaceuticals, Rensselaer, NY 2000 – 2003
Manufacturing Associate/Shift Lead
Managed employee performance, training and certifying 7 employees to manufacturing processes, documentation and regulatory requirements
Oversaw all aspects of clinical purification such as chromatography, ultrafiltration, spectrophotometry, preparation of buffers and cleaning solutions in accordance with cGMP and safety standards
Technical Skills:
Filtration, Protein Purification, Cell Culture, CIP/SIP, IQ/OQ/PQ, FAT/SAT, Statistical Analysis, Auditing, Chemistry Manufacturing/Controls, Root Cause Analysis, Project Management, Technology Transfer, Validation Master Plan, Quality Systems, Failure Mode Effect Analysis, Aseptic Processing and Fill, Change Control, Lean Manufacturing, Budget Management, Microsoft Project, Microsoft Office Suite (Word, Excel, PowerPoint)
Education:
Plymouth State University, Plymouth, NH
Master of Business Management
Campbell University, Buies Creek, NC
Bachelor of Science – Pharmaceutical Sciences
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