Joseph Knowles Email & Phone Number

Denton, Md, Us

Lansdale, Pa, Us

Directed a team of 18 in Sales Support, Commercial Business, Operations, and Warehouse activities to support a customer-focused business manufacturing, processing, and configuring braided material based upon industry application needs. Led E2E business and process flow of all daily site activities meeting customer delivery requirements and strategic initiatives based upon sales forecast and internal /external site needs.• Managed team driving OTD monthly requirements (95%), Safety (Zero Incidents), Quality (< 2 Quality Events/month), Costs (below target scrap costs of $10K/month and > $600K/month revenue). Consistently met KPI’s while understaffed in critical areas of production.• Developed site Near Miss / Safety Suggestion program to proactively address safety concerns and improve processes. Collaborated with Global EHS to develop and implement standardized procedures for monthly fire extinguisher checks, site emergency egress, and assessment-based forklift training (COGS savings of $1,500/year).• Managed start to finish project in the delivery, installation, and validation of new braiding machines. Initiated CapEx to include spare parts inventory needs, TPM, and increase machine capability.• Identified and implemented production continuous improvement opportunities decreasing lead time (30%) and reducing labor costs (40%) by eliminating non-value activities, streamlining processes, and improving material press process. New lean initiatives included site-wide 6S project and production / planning visual controls.

Salisbury, Maryland, Us

Managed three Shift Supervisors within an organization of 65 packaging employees. Directed packaging of solid dose operations for two bottle fill lines of various bottle counts / configurations, one blister fill line, and bulk fills per FDA filing specifications. Managed progress and authorship of packaging operations deviations, change controls, and SOP revisions. Accountable for solid dose packaging (tablets and capsules) per batch record requirements based upon contractual sales agreements with customers. • Met / exceeded monthly requirements for FY22. July 2022 exceeded packaging target by 20%.• Led upgrade of current version of serialization software. Tracked and projected all issues associated with current software and impacts to meeting dosage requirements OEE metrics. Decreased unplanned serialization downtime issues by 35%.• Collaborated with site leadership in developing and implementing a staffing plan to align with projected increase of sales. Staffing plan absorbed 3rd shift employees into 1st and 2nd shifts increasing overall efficiency by 30% and 20% cost reduction in labor.• Aligned with site continuous improvement in roll-out of OEE tracking system (TrakSYS). Initiated standard downtime reasons, packaging line performance, identifying OEE owners, and employee training as part of roll-out requirements. • Created and implemented packaging operations culture change plan aimed to change its current culture to a more disciplined compliance culture with emphasis on safety, RFT, quality, compliance, and execution with a sense of urgency using the ADKAR (Awareness, Desire, Knowledge, Ability, Reinforcement) model.

Manager of operations for the Emulsions lab. People manager of 4 lab technicians. Emulsions lab manufactures finished product that is formulated with various antigen inputs and filled into 500ml bottles as finished product.Key Roles and Accomplishments:• Responsible for formulation blends of various antigen inputs. Critical calculations in determining ideal blending mix to meet USDA governed Order of Outline requirements such as theoretical tier/dose, input percentages, and quality critical specifications. Key team lead for Breedervac Cognizance team reporting out titers, volumes, and planning to meet production schedule requirements.• Project lead/change manager in replacing key grinding equipment used in Emulsions and Filling/Freeze Drying labs. Initiated PO for purchase of second homogenizer unit valued at $160,000. Lead stakeholder in identifying process efficiencies in using homogenizer.• Shared management responsibilities with Filling/Freeze Drying lab. Lab has 17 technicians. Responsibilities include leading/facilitating tiers, assist in investigation efforts associated with deviations, provide labor support during understaffed processes, and approve ADP timecards.• Identified cost saving initiative for SE Emulsions products. Was able to determine cost of inputs for SE Emulsions products in collaboration with Finance. Proposed cost savings decreased cost of input from $73.35 per bottle to $69.30 and reduction in antigen inventory by 50%. Efforts also included collaborative efforts with Bio-Technology Services team utilizing promising ELISA test method on antigen.

VBF manufacturing support responsible for all levels of virus suite/cell propagation support in meeting production targets for schedule adherence, DM investigations, RFT, and training. VBF Peripheral Equipment Manager and Safety Champion. Key Roles and Accomplishments:• Lead technical, compliance, EHS, and continuous improvement support person for Virus Processing suite. Responsibilities include equipment and maintenance reliability/tracking, Process Simulation lead, JSA revision and review, CAPA assignment and successful closure, and process/EM training. As VBF Peripheral Equipment manager, lead multiple shifts and areas in weekly shop floor GEMBA’s and reported GEMBA score results as part of VBF Virus overall performance in alignment with department and site goals.• Project lead with projects associated with accelerated process training, GLIMS environmental monitoring, aseptic qualification, materials management via SAP T-Codes, and continuous improvement. Developed, scheduled, and implemented training associated with 5th Wheaton Cart project which increased HVF yield above 2018 target.• Technical writing experience with associated documentation such as process protocol support, VBF JSA’s, SOP revisions/redlining via MIDAS, KPI tracking/reporting, and Standard Work. Critical leadership in Thaw Bath protocol training, implementation, and multiple shift hyper care support with the objective to provide quantifiable data in establishing root cause for Thaw Bath mold hits during EM testing.• Facilitate and participate in Level I and Level II Tier discussions pertaining to safety, quality, schedule adherence, training, maintenance work order review/closure, and after action item review/reporting of assigned tasks. • Alternate Training Program manager in meeting VBF critical training/upskilling needs. Delivered 10 process ready robotics technicians on time within the Alternate Training Program (2nd Qtr 2019).

Varicella Bulk Facility Virus technician responsible for meeting daily robotic processes pertaining to the planting, refeeding, seeding, and harvesting viral fluid for downstream processes per production schedule.Key Roles and Accomplishments:Performs various operational tasks within a Grade A and B Clean Room aseptic environment.Set-up and breakdown of vaccine production equipment in accordance with SOP's.Actively follows lean manufacturing/5S/Kanban principles in compliance with cGMPs. Manages production components and aseptic procedures for transfer of materials via aseptic techniques. Operates/monitors production equipment such as RCCS, Shell Freezers, Wheaton Carts, Tube Welders, and Peristaltic Pumps.Insures production equipment is QC compliant for the manufacturing of sterile product.Advanced user of computer systems such as SAP, MES, LIMS, DeltaV, and PLC.

Processed raw material/active ingredient for granulation using mixing, drying, and blending processes.Active participation in Lean Manufacturing practices and other cost saving initiatives such as 5S, Six Sigma, SMED, and Continuous Improvement.Routine demonstration of in-process quality measures.Worked cross functionally in initiating process upgrades and reductions in labor costs.Resolved quality investigations using root cause analysis and investigative reporting.Knowledgeable and active participation in preventive maintenance as well as system upgrades.

Washington, Dc, Us

Inventory management and control over critical air wing parts and service. Includes both helo and fixed wing aircraft.