Paul Lockner Email & Phone Number

Kalamazoo, Mi, Us

Kalamazoo, Mi, Us

Kalamazoo, Michigan Area

Coordinates and monitors engineering projects.Provides input on design criteria and equipment lists for complex processes.Coordinates detailed process description narratives, process flow diagrams and P&IDs.Coordinates with other disciplines to ensure necessary project details are executed and documented on construction drawings.Research equipment providers and make recommendations and selections based on client and project requirements.Research specifications for complex equipment.Monitors testing requirements and attending factory acceptance tests (FATs) for equipment.Tracks projects after construction documents are issued reviewing submittals, answering RFIs and making field visits to verify progression of project scope is proceeding per design intent.Research packaging materials (e.g. containers, labeling and primary/secondary/tertiary packaging).

•Review and investigate customer complaints •Determine product failure root causes and evaluate risk of failures •Investigate related failures, design, and manufacturing history of failed devices •Determine and analyze trend results to input into post market product failure data •Communicate with internal and external resources globally as necessary to obtain details related to customer complaints

Stryker

•Review and investigate customer complaints•Determine product failure root causes and evaluate risk of failures•Investigate related failures, design, and manufacturing history of failed devices•Determine and analyze trend results to input into post market product failure data•Communicate with internal and external resources globally as necessary to obtain details related to customer complaints•Perform adverse event filings, including MDR and MDV reports•Evaluating regulatory impact of proposed changes to launched products

Thermo Fisher Scientific

• Provide leadership to Quality Control and Quality Assurance colleagues in day-to-day operations• Serve as Quality Liason in site management meetings• Serve as Quality Liason for production quality concerns and feedback • Manage and trend non-conformances. Provide risk based recommendations on rework strategies or scrap decisions.• Support quality audits (FDA, customer) and subsequent company response.

Bangor, Mi

Provide leadership and technical expertise to Microbiology Group at Marrone Michigan Manufacturing. The group is responsible for Quality Control testing of raw materials and commercial products within cGMP requirements. The group also serves as manufacturing support for fermentation inoculum development.Represent the site for tech transfer of new testing methods and production strategies.

Subject Matter Expert for all Downstream Processing operations on campus.Technical lead for all Extractables and Leachables evaluations.DSP technical lead for Pilot Plant renovations. Responsibilities in this role included assisting in facility re-design as well as capital equipment selection and procurement (total equipment budget of ~8MM).Process Owner (DSP Ops) for recombinant Anthrax vaccine candidate purchased from external company. Responsibilities in this role included tech transfer from documentation of Phase IIA project into manufacturing (1300L), assisting in facility re-design to accommodate the new process as well as design and selection of new capital equipment to support TFF and Chromatography operations (total equipment budget of ~3.8MM). Technical lead to identify all small equipment, consumables and component needs. Provided guidance to Compliance group as to new materials and vendors requiring GMP audits. Served as Technical Auditor for testing labs and raw material suppliers.Participated in FDA and PHAST audits.Major Accomplishments:Completion of two facility Detailed Design packages for incorporating new processes and improved workability of existing manufacturing plants.Tech transferred and scaled FDA approved vaccine from legacy to newly constructed plant (12 fold increase in scale). Process Validation currently ongoing.Led multi-disciplinary team to complete Factory Acceptance Testing of capital equipment. During the two weeks of testing, 348 punchlist items were identified, 94% of which were closed out prior to end of trip schedule.Reduced 92% failure rate to 0% for a formulation unit operation.

Duties previously listed as well as expansion of support to include all bacterial and viral antigens (both discovery and development).Recognized as expert in DSP operations within Veterinary Medicine Group.Scouted Outer Membrane Extraction strategies for new platform of cell-free vaccine candidates.Analytic support increased to include Capillary Electrophoresis and Endotoxin Assay (LAL).GLP Officer role increased to support Cell Culture and Formulation Groups.Major Accomplishments:Successfully scaled and tech transferred Mammalian Cell Culture TFF Operation from bench to pilot (75L) to manufacturing scale (400L).Successfully tech transferred analytical methods to CRO and partner groups within Pfizer.Led cross-functional team to produce biological adjuvant for Discovery projects.

Duties previously listed as well as expansion of technical support to include centrifugation, membrane and resin chromatographies.Scouted Inclusion Body dissolution and refold strategies.Consulted with Discovery Colleagues on technical issues, scientific approaches and participated in push-pull meetings.Served as GLP Officer for Fermentation Group.Oversaw new DSP lab renovation.Oversaw Fermentation and DSP lab relocations from CT to MI.Major Accomplishments:Created cGMP Master and Working Seed StocksScouted and scaled chromatographic purifications from bench to pilot scale (100L).Scouted and scaled peri-plasmic antigen release strategies from bench to pilot scale (100L). Successfully scaled and tech transferred TFF optimization for continuous improvement project from bench to pilot (100L) to manufacturing (scale 10,000L).Successfully scaled and tech transferred inclusion body dissolution, depth & normal flow filtration and refold from bench to pilot (100L) to manufacturing scale (10,000L). Led tech transfer team for this project..

Subject matter expert for DSP operations within Fermentation.Provided bench & pilot scales capacities for Tangential Flow (TFF), Depth and Normal Flow (NF) Filtrations.Provided analytic support within Fermentation Group for SDS-PAGE, Western Blots and protein quantification assays in microtiter and Radial Immuno-Diffusion plate formats.Assisted in fermentations at 20 and 100 L scale on B Braun systems.Major Accomplishments:Successfully scaled and tech transferred TFF Operation from bench to pilot scale (100L) to manufacturing scale (10,000L).Successfully scaled and tech transferred NF Operation from bench to pilot scale (10L) to manufacturing scale (200L).NF work eliminated a process contaminant, resulting in recovery of 3MM per month scrap loss. Awarded Pfizer Impact Award.

Bs, Biochemistry

Education record