John Quarles Email & Phone Number

New York, New York, Us

Novato, California, Us

Novato, California, Us

Boston, Massachusetts, Us

• Leads and supports tech transfers of newly developed products from R&D or existing manufacturing facility to external clinical manufacturing facilities (CMO).• Provides SME support for the cell culture and/or purification operations of clinical drug substance manufacturing. • Authors technical documents in support of process tech transfer, manufacturing history, and change control. • Provides SME assessment support on deviation investigations and product impact assessments. • Acts as liaison between Alexion and CMOs for the technical transfer and manufacturing of clinical products.• Provides manufacturing floor support for troubleshooting and general technical oversight of process at external manufacturing facilities.• Identifies and coordinates scientific activities to support short term operational goals; influences the work group by providing expertise. • Evaluates impact on manufacturing process due to changes in areas including raw materials, facility, equipment, and scale. • Interfaces with CMO and internal resources to identify and implement appropriate process improvements. • Prepares reports or other documents in a timely manner to enable regulatory submissions. Reviews IND, IMPD and other technical documents for regulatory agency submissions.• Ensures open communication and effective collaboration of all involved functions and external parties• Provides technical support on an as needed basis to other areas including drug product and R&D life cycle management programs

Paris, France, Fr

• Provide expert technical support to GMP Thyrogen purification operations and assist in maintaining the process in a reliable state of control• Develop and maintain process knowledge and ownership.• Perform process monitoring using a variety of data analysis techniques.• Provide expert technical support and analysis for the resolution of deviations, investigations, and process issues.• Identify, own and resolve issues proactively.• Lead/assist in the proposal, initiation, testing and implementation of proposed changes to the purification process.• Complete technical investigations and provide on the floor technical expertise.• Support inspection readiness and maintain an inspection-ready state.• Generate documents related to process monitoring programs and non-conformances.• Lead and participate in cross-functional initiatives

London, Greater London, Gb

• Managed assigned client projects in the Devens and North Andover Pilot Plant• Communicated, interacted, and worked closely with external customers, JMPS technical support personnel, Quality Control department, Quality Assurance department, and Plant chemical operators.• Performed time and material estimations for new project proposals• Effectively completed technical information transfer between method/process development and manufacturing operations• Coordinated internal teams and external clients, act as technical lead and ensure assigned projects are completed on time, within budget, and fully meeting client expectations• Converted proposal and technical packages for assigned projects into batch records• Created and reviewed manufacturing batch records, deviations, Standard Operating Procedures (SOPs), and equipment validation protocols within the JMPS Quality System• Reported progress in writing and/or presentations regularly in order to identify internal and external factors jeopardizing the project and recommend solutions to any problems that arise• Trained pilot plant chemical operators on batch records, deviations, safety procedures, and SOPs• Participated in weekly maintenance and production meetings.• Provided engineering support for process equipment upgrades and modifications. Oversaw commissioning and validation activities for these process improvements.• Provided engineering support for Process Safety Management initiatives

Paris, France, Fr

• Reviewed, provided input and approved Facilities and Manufacturing Standard Operating Procedures to align with Good Engineering Practices and site governing procedures. • Lead for Myozyme Purification re-initiation project. Managed equipment remediation activities and provided guidance to junior engineers. Reported status to project team and customer.• Provided Engineering support for Genzyme Safety Program initiatives. • Subject Matter Expert on Purification equipment and systems; Engineering SME for Change Controls, lead troubleshooting of equipment, developing preventative maintenance procedures, and maintaining engineering documentation. (e.g. Engineering SME for redundant chromatography column change controls, wrote PM procedure for new chromatography column, lead troubleshooting for column UV meter)• Provided engineering support for process equipment upgrades and modifications. Oversee commissioning and validation activities for these process improvements. • Served as Engineering lead for cross-functional projects to support site initiatives (e.g. Redundant Chromatography Column Project, Myozyme Purification Re-initiation) • Served as Project Manager for small projects. Responsibilities include developing small to intermediate project scopes, schedules and budgets. Ensured that projects comply with cGMP, ASME BPE and regulatory requirements.

• Provided technical support to operations in troubleshooting both process and equipment related problems.• Provided daily front-line process engineering support for GMP Unit operations in order to meet production schedules.• Managed implementation of various countermeasures and recommendations.• Achieved cycle time requirements in order to meet the production schedule.· Served as Engineering SME for Process Hazard Analyses (PHAs) for manufacturing operations. • Prepared and revised production batch records and standard operating procedures (SOPs).• Provided training to manufacturing operations on production batch records and SOPs.• Acted as DEA coordinator and followed all regulations, policies and procedures• Identified opportunities for systems and process improvements.• Trained as HAZMAT and Emergency Responder.• Perform chemical operations as required

Indianapolis, Indiana, Us

• Provided daily front-line process engineering support for BHI GMP manufacturing unit operations (Crystallization, Chromatography, Chromatography Column Packing, TFF, Evaporation, Various Reactions, Buffer Makeup, Cell Culture Operations, Cryogenic Storage, Autoclaves, Straw/Vial Filling, Clean Steam Generator, Water for Bulk Storage Operations (WBSO) Supply, Biosafety Cabinets, Controlled Rate Freezers, Liquid Nitrogen Supply).• Performed troubleshooting activities and documented root cause investigations for deviations.• Examined/modeled processes/projects using Aspen and Fathom.• Managed implementation of various countermeasures and recommendations.• Maintained and established technical information (i.e. P&IDs, PSI, user requirements, qualification documentation, etc).• Developed control systems to monitor and ID gaps in process/performance metrics.• Monitored established control systems for process indicators to identify/follow-up on significant issues.• Served as Engineering SME in Process Hazard Reviews• Worked with safety representative to ensure processes/equipment followed applicable safety guidelines (i.e. OSHA, PSM, etc).• Provided technical expert/support for installation, qualification, and maintenance of new process equipment/instrumentation and process equipment/instrumentation modifications according to industry standards (e.g. FDA guidelines, ISPE Baseline Guides, USP Guidelines, ASME BPE, etc.)· Lead, wrote, and performed qualification plans (User Requirements, Design Qualification, Installation Qualification, Operational Qualification)• Transferred knowledge of equipment capabilities and operational techniques to operations and maintenance personnel (e.g. training, SOPs, PM checklists, etc)• Worked with cross-functional teams and developed/maintained process improvement activities for capacity (yield, cycle time, etc), product quality, raw material cost, process variability, process safety

Master Of Science - Ms, Engineering Management

Bachelor Of Science, Chemical Engineering