* Promotion: QC Product and Raw Material Testing – Leading a team of chemists and microbiologists responsible for testing of all Raw Materials and Drug Product batches.* Evaluating lab investigations, deviations, and associated corrective/preventive actions and ensuring they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products.* Tracking and trending analytical data to ensure data integrity of laboratory results and that all instrumentation and systems are functioning properly.*Curating and improving the QC Laboratory's Continuous Improvement, OpEx, and Visual Management capabilities.

* Evaluated changes that impacted medical devices and combination products in aseptic processing, including change controls, DHF updates, complaints, SOP revisions, and post-market surveillance investigations* Assessed adequacy and compliance of the Site Quality Management System* Provided technical guidance for product and process changes and device risk management* POC and SME for Site Data Integrity Quality System responsible for developing and leading governance and establishing sustainable and effective means of performance monitoring* Continually supported design changes, complaints, procedures, investigations, CAPA implementation and management review* Led quality-related investigations, conduct gap assessments, and distribute metrics for quality reviews

* Successfully led and directed manufacturing groups of operators and engineers within a regulated environment to deliver annual volumes of intermediates and small molecule API in a multi-shift operation, including the largest campaigns in the site’s 25-year history* Championed and fostered a culture of GMP-adherence and high performance in safety, quality, and customer service by developing and implementing safeguards on high-pressure apparatuses and chemical vessels, yield efficiency operations, and streamlined communication with exterior stakeholders* Functioned as site S&OP and collaborated with finance to manage inventory levels and execute logistical strategies to drive improvements; developed improved cadence with vendors throughout the COVID-19 pandemic to ensure a high level of schedule adherence and financial performance* Member of site leadership team; worked with corporate global network to delivery action plans, implement best practices, and budgets to timelines* Identified and led initiatives to monitor plant spend, improve compliance, and manage risk effectively for the business, including recent award of certifications in ISO 14001, 45001, and 50001

* Promoted to direct Propellant Department activities to design new, safer propellants for airbag applications; shepherded scale-up of $7MM project to production launch utilizing BIC pharmaceutical-type processes* During company integration, led efforts to standardize best practices within growing networks - specifically safety-intensive operations - and reduced incident rate by substantial margin* Oversaw and mentored Engineering Development team to assess, establish, and improve propellant raw material supply base to ensure assurance of supply and best practice sourcing strategies* Analyzed technology trends, human resource needs, and market demand to plan projects* Forecasted operating costs of department and direct preparation of budget requests* Represented Engineering while working with external Quality, Legal, and Government associated teams to determine root cause and address safety related propellant and inflator concerns

* Promoted to manage multiple airbag development projects regarding energetic materials as Technical Lead and coordinated all facets of projects including scope, requirements, workflow prioritization, resource allocation, and testing activities* Facilitated and guided new relationships with partners and suppliers in China, Germany, and France to assist in manufacturing drop-in replacement propellant products for recall of inflators* Integrated Design for Six Sigma (DFSS) techniques to optimize product development; led project design reviews that included design input, output, FMEA evaluation, and FTA analysis

* Developed and scaled-up propellant and pharmaceutical-type processes (spray drying, vacuum conveyance, milling, tablet pressing); worked closely with manufacturing plants* Evaluated design and process failure modes and effects (DFMEA, PFMEA, DRBFM)* Worked with propellant raw material suppliers to ensure engineering standards were met during scale up and production* Ensured ISO 9001 and IATF 16949 compliance and supported internal auditing as required

* Led efforts to continuously improve supplier manufacturing quality and capability pertaining to decorative plastics and chrome/electroplated components at 8 U.S. supplier sites* Managed new model launches (e.g. Mustang, Fusion) and change management actions, extensive knowledge of APQP* Coached suppliers on proper development / deployment of Quality Operating System techniques

* Purchasing agent for Printed Circuit Boards responsible for $60MM in global spend* Issued purchase orders and provided system maintenance to ensure timely delivery and cost savings* Assisted product engineering to obtain best prices on materials of construction

* Purchasing agent for Wire Harnesses: $180MM in global spend* Analyzed supply base and raw materials market for budget; handled global negotiations* Led line shutdown issues and interfaced with OEMs

* Compiled purchase price changes and supplier information* Met with buyers and suppliers to discuss part prices