Eric Harkness work email
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My name is Eric Harkness, I am keenly focused on driving enterprise-wide success through proactive change management and comprehensive, strategic initiatives, I am able to promote exceptional across-the-board performance by revitalizing underperforming areas and capturing new opportunities for growth. My track record of success has been reinforced by recruiting high-caliber talent and encouraging professional growth at all levels. Confident I can deliver the same results with your organization, I invite you to review my resume in detail.I am an accomplished and quality-focused professional with more than 15 years of experience in Biotech industry enabling organizational growth through manufacturing operations initiatives while adhering to defined quality standards. I am instrumental in creating data-driven deviations, CAPAs, change controls, process qualification protocols, and summary reports. I am adept at executing product and process improvements by troubleshooting process and equipment problems.I am also proficient at promoting culture of quality and compliance while evaluating manufacturing processes and procedures to ensure strict compliance with cGMP, code of federal regulations, site quality systems, and company policies. I have exceptional communication skills with proven ability to foster robust collaborations with both internal/external stakeholders to ensure smooth flow of operations.Technical Proficiencies:Software: MasterControl, Process Control System (PCS) Unicorn Chromatography software, LIMS, TrackWise, Ross ERP, Syncade MES, OSI PI Historian, Delta V, Veeva QMS, SAP, and Blue Mountain RAMTools: Microsoft Office Applications (Word, Excel, Outlook, and Access)
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Senior Process EngineerLykan Bioscience Nov 2021 - PresentHopkinton, Ma, Us -
Process Engineer IiLykan Bioscience Jul 2021 - Nov 2021Hopkinton, Ma, Us
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Senior Manufacturing SpecialistModerna 2020 - 2021Cambridge, Massachusetts, UsDuring my role as Sr. Manufacturing Specialist, I utilize quality communication skills to represent group at daily deviation triage meeting. In this role, I also provide quality support as manufacturing contact for deviation investigations. I am recognized for tracking production delays for reporting and metrics. It is my responsibility to ensure workplace safety by maintaining strict compliance with defined safety procedures and guidelines. I also drive complex investigations close outs, determine root cause analysis, and implement appropriate corrective and predictive actions while leading cross functional teams. In this role, I also manage overall aspects regarding equipment start-up, commissioning, and validation processes.My Key Achievements for this role:• Reduced processing time of each batch of Covid-19 vaccine by three hours through implementation of change control.• Strategically positioned as manufacturing point of contact for commissioning and validation of new equipment during expansion and scale up to commercial manufacturing of Covid-19 vaccine.• Delivered proactive support to MS&T in development and execution of mixing studies. -
Senior Manufacturing TechnicianAgenus 2013 - 2020Lexington, Massachusetts, UsDuring my role as Senior Manufacturing Technician, I have executed aseptic techniques for completing processes of manufacture products in adherence to defined manufacturing regulations, policies, procedures, and SOPs aligned with GMP guidelines. In this role, I also managed overall manufacturing operations from inception to completion, including purification, solution and equipment preparation, and lab management. I have provided quality assistance with validation protocols, in-process testing, and batch assurance specification and team training. I am recognized for maintaining batch data spreadsheet for use in tracking batch metrics as well as deliver quality assistance in investigations.My Key Achievements for this role:• Developed and revamped SOPs and batch records while improving reliability and sustainability of production equipment through regular maintenance.• Formulated deviations, CAPAs, change controls, process qualification protocols, and data-driven summary reports as well as present to higher management for informed decision making.• Managed various day-to-day departmental operations, including internal manufacturing, QA, QC, PAT, and facilities management aimed at implementing new and improved processes.• Enhanced employees' skillset through quality training regarding SOPs and Batch records while serving as qualified trainer. -
Senior Manufacturing TechnicianShire Hgt Feb 2011 - May 2013During my role as Senior Manufacturing Technician, I have adhered to regulations, policies, procedures, and SOPs in alignment with GMP guidelines. In this role I also established and revamped SOPs while overseeing production equipment maintenance. I supported the validation protocols, in-process testing, and batch assurance specifications and team training. I am recognized for supporting technology transfer of purification processes for four drugs at clinical and commercial scales. I have established and implemented pre-run checklist for daily operations to ensure readiness.My Key Achievements for this role:• Completed various routine tasks, including cell culture, purification, solution and equipment preparation, and lab management for maintaining safe and clean room environment.• Streamlined departmental operations, including internal manufacturing, QA, testing, technical operations, and facilities management for implementation of improved processes.• Utilized quality communication skills to collaborate with vendors with a keen focus on completing Factory Assessment Tests at vendor facilities for achieving equipment approvals prior to transport.
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Manufacturing Technician IiShire Hgt Nov 2009 - Feb 2011
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Purification AssociateNew England Peptide Apr 2007 - Jan 2010
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Custom Sales SpecialistQuality Controlled Biochemicals Oct 2003 - Mar 2007
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Production AssociateQcb/Biosource Feb 1998 - Oct 2003HPLC Purification of peptides. Mass Spec and HPLC analysis of peptides.
Eric Harkness Skills
Eric Harkness Education Details
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Worcester Polytechnic InstituteBiochemistry
Frequently Asked Questions about Eric Harkness
What company does Eric Harkness work for?
Eric Harkness works for Lykan Bioscience
What is Eric Harkness's role at the current company?
Eric Harkness's current role is Senior Process Engineer.
What is Eric Harkness's email address?
Eric Harkness's email address is er****@****hoo.com
What is Eric Harkness's direct phone number?
Eric Harkness's direct phone number is +150893*****
What schools did Eric Harkness attend?
Eric Harkness attended Worcester Polytechnic Institute.
What skills is Eric Harkness known for?
Eric Harkness has skills like Hplc, Purification, Peptides, Biotechnology, Chromatography, Mass Spectrometry, Gmp, Biochemistry, Life Sciences, Protein Chemistry, Elisa, Validation.
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