Benjamin K. Email & Phone Number

Full service definition and leadership of new Quality management system in preparation for initial ISO13485 MDSAP certification, and FDA pre-approval inspection to 21CFR820. Quality engineering support for new product development, risk management (to ISO14971), and verification of product compliance to applicable standards in Design History File (DHF). Build quality management team in preparation for product commercialization.

Switzerland 🇨🇭 , Ch

-Negotiate process integration from acquired company (GenMark Diagnostics) in supplier quality, supply chain management and audit program currently in force with Roche global standard practices and modular QMS system. -Write new procedures, develop process flows and mentor/train others in best practices in quality audits, purchasing controls, and integration with design controls.-Identify and correct gaps using a tiered decision making process and project plan for suppliers in current use.-Assess how existing and new supplier are qualified for use and how performance from them is managed based on impact/risk to the product design or to compliance (regulatory requirements and contracts). -Consult with internal staff on ideas for controlling operational cost (i.e. inspection, material qualification and change assessments) where risk is low, and how best to control potential failures when the risk impact is high. Also consulted on plans to bring higher risks to GenMark business to a lower level with suggested critical supplier development work based on the needs of their processes and design requirements.

Develop and execute quality plan to:1. Gap assess entire quality system for compliance to 21CFR820, ISO13485:2016 and ISO14971: 2019 while preserving and enhancing processes related to combination device clinical trial management and biologics GMPs per 21CFR210/211 and part 600. 2. When the gaps are agreed to, revise all procedures to address all gaps with partnership from customer process owners and process recipients. Employed process mapping, lean process analysis and development, standardized records creation, flow, approval and storage/maintenance to improve audit flow and final results during ISO13485:2016 certification.3. Develop training materials and deliver training for major changes to these processes.

New Brunswick, Nj, Us

Help to anticipate and mitigate operational and quality system risk for client (J and J hospital and medical technologies division-HMT) by evaluating compliance and gaps to compliance to Swiss Medical Device Ordinance, and EAEU (Eurasian Economic Union). This work utilized the assessed gaps to drive changes in the various layers of quality systems within the J and J Hospital and Medical Technologies division. This was accomplished by:1. Received certified translations of the regulations and with team support, breaking down its components into single requirements that may be addressed by one or more procedures.2. Gaining access to multiple quality systems to evaluate congruency of procedures to the requirements at multiple layers of the J and J HMT division. 3. Consulted with J and J subject matter experts/process owners to review the gaps to gain alignment and identify/drive actions intended to close the gaps where current processes/procedures did not adequately address the new requirements.

San Francisco, Ca, Us

Assist client company evaluate its quality management system for compliance to ISO13485:2016, FDA 21CFRPart820, and EU-IVDR. Complete Gap Assessment-then evaluate options with client stakeholders to deploy improvements within the organization and then develop the plan to bridge the gap. Per the plan1. Developed procedures2. Revised workflows3. Revised metrics to improve quality of data and relevance to the business and QMS4. Revised policies, and removed obsolete workflows and policies5. Develop and deliver training materials, and train stakeholders using real time interactive sessions to drive the knowledge into the organization. 6. Remediate records to comply with new process. This was done to not only improve compliance and increase chances of success for PAI by FDA and to improve outcomes for IVDR audit but to place the business into a better, long term position for lean, efficient and value added compliant operations.

San Diego, California, Us

As a knowledgeable practitioner that has operated under several bodies of medical device law (different countries) and their practical implementation in business and personal R&D experience in drug formulation and materials engineering, I have completed a role at TriLink Biotechnologies, an innovative contract manufacturer poised for tremendous growth supporting new product development for medical device and pharmaceutical GMP customers as well as research institutions. I was tasked with leading a team of high level quality assurance professionals (team of 8) in the management of the TriLink quality systems including leading projects to transform the way the company manages change control, training, CAPA, deviations, supplier quality management, document control in to improve the company's GMP compliance position and improve record content quality, and expedite the processes through the removal of non-essential steps and process bottlenecks. Lead the implementation of Master Control for CAPA, document control, OOS, deviations, non conformity, complaints and change management. Completed implementation of documents management and training, as well as ushering in a stronger and more secure data integrity program with a software validation infrastructure.

Assist company to address backlogged CAPA projects by partnering with internal stakeholders to develop appropriate solutions. Responsible for team meeting facilitation, root cause analysis training and facilitation, documentation within the CAPA, and guidance of team members. Assess health of the quality system through audits and recommend changes and updates where needed. Responsible for audit planning, meetings, execution, reporting and follow up. Implement additional modules into E-QMS AssurX system (Catsweb) as needed. Responsible for protocol write up and execution.

San Diego, California, Us

Select key suppliers to assist Dexcom its business transformation.Audit/develop critical suppliers to a variety of different standards and laws depending on the scope of work. This includes ISO13485, ISO17025, 21CFR820 for quality management systems, and multiple other standards depending on the specific type of services and/or goods (i.e. ISO10993, ISO 11135-1, ISO 11137-1, ISO 14937, ISO 14160, ISO 17665-1, design and process validation oversight, etc.)Partner with suppliers on quality system and process level deficiencies through win-win negotiation to ensure Dexcom's requirements can reliably be met. Advise, train and mentor lower level engineers in approaches to process validation, design and development methods and tools, Corrective/preventive action and root cause analysis, and auditing techniques. Assist/advise Dexcom supplier quality with compliance related work (third party audits, communications with regulatory authorities) as needed and quality system improvements (i.e. material qualification, supplier selection, auditing, etc.).

Abbott Park, Illinois, Us

Accomplishments:• Assisted client with coordination of CAPA system resources to provide a seamless solution to address a large backlog of CAPAs. • Gave direction on how to apply Abbott CAPA policies and procedures.• Developed guidance on how to address non-standard situations such as criteria and justification for CAPAs that were opened but only needed correction, and not corrective action (i.e. software patches). • Trained other engineers in investigation techniques, methods of documentation, and the development of a logical narrative intended to convey complex information in the most effective way. • The team helped CAPA owners move 50 late CAPAs forward Responsibilities: • Lead team of 9 temporary engineers to guide the progression of over 100+ CAPAs• Represented CAPA system for external auditing agencies.• Developed and reported CAPA system metrics to senior management.

Los Angeles, California, Us

1. Lead the Quality Management system through a time of significant change.2. Upgrade the QMS to comply with ISO13485:2016, MDSAP, and MDR in Europe.3. Develop and maintain operational metrics and data collection systems.4. Manage quality resources.5. Modernize elements of the QMS to reduce effort and maximize resource allocation. 6. Host 3rd party auditors/inspectors7. Support engineering efforts for new product development.

• Lead team to develop and prepare for first FDA inspection. Also lead FDA mock audits.• Developed internal audit program and lead several internal audits, • Developed the supplier quality assurance program and trained others to run it. • Developed company CAPA system, non-conformance system and updated all other quality systems to ready company for commercial operation.• Deployed "lean" manufacturing and quality principles, in processes and procedures using appropriate service and performance metrics• Evaluated the Design History File for gaps to relevant standards and to design risks (using processes defined in ISO14971) to help the team improve the likelihood of a successful Pre-Market Approval submission on a class 3 implanted device and all accessories. • Executed multiple engineering studies relating to material change, compatibility, and physics inside of the device to address FDA concerns.• Prepared quality system for eventual ISO13485 conformity

Brea, California, Us

• Lead projects on the transition of IRIS International into the Beckman Coulter Quality System. • Developed and executed plans for the remediation of the CAPA system, Design controls, and process validation. Also included work to integrate complaint handling system with the CAPA system, and other changes.• CAPA age reduced by 60% (mean age was greater than one year).• Unresolved process deviations reduced by 90%.• Supported the execution of major design changes and continually updated risk management files as needed while ensuring that overall design controls were being followed at the plant.

Forchheim, De

• Formal management and leadership: Quality leadership and management representative over three Siemens’ physical sites and lead Quality Management team-8 employees. Successful guidance/leadership for several ISO 13485 and FDA audits.• Guided plant quality management practices during a time of significant change to global Siemens management system policies and business culture. • To ensure effective implementation of these policies, I coordinated teams to modify and improve the performance of business systems including the local Quality Management System.• Program Team Leadership: Division level Quality System support in response to warning letter- CAPA system, Process validation practices, and design controls systems retooled from the ground up using multiple site best practices and external benchmarks. • Sites worked under 21CFR 820, ISO13485, CMDCAS, Japan Ordinance 169 and overall JPAL, European IVDD. • Developed/maintained plant level performance and service metrics: Reduced design change project turnaround times by 50%, change order turnaround time by 30%, non-conformity deposition by 80%, etc. As a result, more time was available to do more value added work.

Fridley, Minnesota, Us

• Improved Manufacturing Processes: Improved process results using formal techniques (i.e. DMAIC) for drug delivery device subassembly-reduced scrap rates by 20%; improved throughput by 10%. Improved yield on Elanco syringe process by identifying process risk, developing appropriate control measures based on design requirements and process limitations-yield increased from 85% to 99+% base on units attempted versus passing units made• Coordinated plant Internal Audit Program. Improved non-conformance response rate by 50%, improved effectiveness rate from 75% to 90%, drove multiple audit methods-process, system, and element audits.• Project Leadership: Coordinated Corrective and Preventative Action Program. Converted Plant CAPA system form a paper based system into electronic only system. Improved process flow and enhanced training program. Result was over 95% on time delivery of CAPA’s and over 95% effectiveness. Lead teams in managing their CAPA projects effectively. • Helped to design a plant training program, constructed training in QA and Operational Excellence tools and industry regulations, and implemented classroom instruction. Over 100 employees were trained, and passed their exams resulting in reduction of defect rate on several product lines.

• Improved Manufacturing Process: Used data from SDS-PAGE, HPLC (RP and SEC) FTIR, Malvern Particle size and Zeta potential measurement for evaluation of novel protein-based dispersions to drive improvements to critical reagent performance metrics. First time pass yield on Flu A antigen process improved from 70% to 95% and reduced processing time; resulting in reduction in production cost of 25% per milligram produced. • Defined a reference materials control program to reduce lot-to-lot performance drift of these materials. Reduced scrap rate of non-conforming lots by 50% (10% to 5% rate) resulting in a savings in excess of $300K per year.• Supported team by analyzing data and by designing effective and inexpensive experiments to solve yield, activity and concentration variability for Flu antigen, Strep A antigen and antibody functionalized dispersions. • Coordinating a team of scientists, and line manufacturing staff; improved the capability of key manufacturing processes (protein conjugates) reducing rate of failure from 15% on average to less than 1%.

• Lead Material qualification activities for components directly used in the design of a Class III implantable medical device (Drug Eluting Stent) and concurrently supervised the analytical lab. Wrote portions of CMC sections for drug eluting device including material design and control, extractable/leachable and material compatibility studies.• Assistant in the design of the drug formulation used on the drug eluting stent. Developed rate release models, physico-chemical models to define product design controls, etc. • As a Technical QC Lab Leader (Title-Senior Chemist) I was responsible for the work of 11 people and improved internal service quality by reduction of turn-around time by 30% and error reduction by 50% through a combination of voice of the customer processes, and through improved process control in the lab.• Conducted supplier development activities to reduce impurities and improve material processing ability (i.e. melt range, viscosity, mixing efficiency, etc.) through chemical analysis and correlation to processing factors. This helped to allow the use of an inexpensive bulk polymer as a drug product excipient.• Improved raw material flow logistics: shipping and handling, storage controls leading to reduction of scrap by 40%.• Participated in designing supply contracts with material vendors while concurrently reducing technical and quality assurance risks for excipient polymers at vendor site.• Developed, validated and documented novel chemical analysis methods, verified and modified compendial methods, and qualified GC’s, mass specs (LC-MS and GC-MS), GPC’s, Karl Fisher titrators and FTIR’s (other systems as well) in a cGMP environment (Class III -implantable stents and stent delivery systems).

• Lead team of employees to support various medicinal R&D teams in reaction development and drug-lead optimization. • Lead research, development and method optimization for high throughput analytical methodology using LC-MS-ELSD, LC-MS-MS, SFC-MS-ELSD, HPLC, FTIR, NMR (H and C) and other techniques. Wrote protocols and participated in writing chemical analysis controls for early phase drug and formulation development. Increased LC-MS-ELSD throughput from 50 samples/week to more than 850 per week• Consultant on novel chemical analysis needs. Conducted stability tests in-vitro of drug candidates.

Mba, Business Operations

Bachelor’S Degree, Chemistry