Robert D. Haddon

Fort Worth, TX 707-***-****

adyxb2@r.postjobfree.com

PROFESSIONAL SUMMARY

I’m a proactive, performance-driven professional with 20 years of progressive expertise in all areas of the highly regulated biotechnology and pharmaceutical production environments. Some examples of my experience include purification and cell culture startup procedures, tech transfer, validation exercises, and extensive quality assurance activities including complex root cause analysis, batch release and quality agreement negotiations. I have a comprehensive understanding of business priorities and experience in Lean/Six Sigma methodologies. I am

committed to flawlessly managing operations and value adding projects while utilizing my skills as a communicator who easily interfaces with staff, customers, and vendors at all levels. I am a seasoned and results oriented people leader, proficient in diverse leadership principles and focused on empowering the workforce to exceed anticipated goals.

Key Skills

● Proven team leadership experience with an emphasis on people development, Conflict resolution and performance management. Teamwork, adaptability, problem-solving, time management, attention to details, and instilling a great work ethic.

● CMO quality management experience. Including: QTA negotiations, Batch Release overview, Inspection coordination, deviation/investigation coordination and managing business relationships.

● Wide-ranging knowledge of the production industry and related processing equipment including validation work.

● In-depth experience with production scheduling and execution and capacity planning using SAP and other manufacturing planning systems, budgeting skills with emphasis on Cost Reduction

● Extensive research, investigation, root cause analysis, complex problem resolution, and technical writing experience SOPs and Technical Documents

● Comprehensive understanding of compliance, safety, quality, document review/release and cGMPenvironments. Studied Cdisc Standards, Clinical Research, Clinical Works and Crfs

● Experience with Six Sigma and Lean Manufacturing tools studying data integration, data management, data quality, data transmissions, data validation, database administration, forecasting and relational databases.

● Experience with cross-functional governance project management concepts, methods and practices Key Responsibilities

● Coordinated all quality operations activities for multiple CMO facilities across the globe simultaneously. Including negotiation of Quality Technical Agreements, navigating deviations/investigations with approval responsibilities, reviewing and approving all Change Controls, reviewing and approving all Master Batch Records, ensuring review and coordination of Batch Release package for conditional as well as full Batch Release. Coordinating site inspections and managing the expectations and responsibilities of the CMOs as well as cultivating a cooperative business relationship between the CMO and the Primary.

● Lead, developed, motivated and provided first line supervision for technician groups from 7 individuals up to 40, ranging from new hires to senior manufacturing and engineer associates.

● Supervised the daily operations of each department, emphasizing compliance with safety, cGMPs, quality compliance, and company policies resulting in zero major safety or compliance violations related to my direct reports during my entire tenure as a supervisor.

● Coordinated activities with support groups and represented each department that I functioned in as a subject matter expert on numerous process steps.

● Work with all Microsoft suite software

● Developed and led culture changing initiatives as well as production line innovation enhancements at every post

● Performed initial investigation and root cause analyses as well as completing CAPA related actions with a high degree of success in order to close discrepant events and investigations on time.

● Coordinated equipment utilization with support groups in fast-paced and complex processing environments with extremely reliable accuracy.

● Initiated new, and revised current MPRs, BPRs, and SOPs

● Actively involved in validation processes for startup and tech transfer

● Partnered directly with planning departments to ensure production schedules remained accurate and shipping goals were achieved. 2

EXPERIENCE

Haddon Homestead, Fort Worth, TX (Current Project) 2023 Homesteader (Small Scale Homesteading),

Responsible for oversight of a small niche homestead location. Manage overall maintenance of equipment and enclosures including general construction and demolition. Responsible for care and re-provisioning of farm fowl, swine, and other livestock. Including feeding, administering supplements, birthing assistance, minor veterinary surgeries (e.g. ear and tail docking, castration, tooth clipping and tagging), dispatching for butchery, ensuring clean paddocks and shelters and monitoring inventory. Novavax, Gaithersburg, MD 2022-2023

Quality Manager (Quality Operations [CMO]),

Coordinated all quality operations activities for multiple CMO facilities simultaneously. Including negotiation of Quality Technical Agreements, navigating deviations/investigations with approval responsibilities, reviewing, and approving all Change Controls, reviewing and approving all Master Batch Records, ensuring review and coordination of Batch Release package for conditional as well as full Batch Release. Coordinating site inspections and managing the expectations and responsibilities of the CMOs as well as cultivating a cooperative business relationship between the CMO and the Primary. OsteoMed, Addison, TX 2021-2022

Principal Supervisor (Year End Inventory Count Project), Responsible for the coordination of the total year end inventory count from November-January. Created a process for coordination of counters and verification of all material with an emphasis on capturing results in SAP for submission to the finance department.

Alcon, Fort Worth, TX 2019-2022

Manufacturing Supervisor (Pharmaceutical/Surgical processing), Responsible for the direct oversight of 6 GMP high speed manufacturing production lines. Responsible for driving development and implementation of several enhancements to line of principle responsibility resulting in the ability to achieve a 19% daily increase in throughput goals (across three shifts) resulting in 1.1 million in increased product revenue yearly.

BioMarin, Novato, CA 2018-2019

Manufacturing Sr Supervisor (Upstream processing), Directly responsible for a GMP biopharmaceutical manufacturing operation with emphasis on Bacterial based fermentation, centrifugal separation, homogenization, filtration & concentration operations utilizing a TFF processing skid, as well as buffer and solution preparations. Managed a department project for a complete overhaul of all storage and furniture equipment within the ISO7 production suites (4 suites in all) with a budget of 600,000 dollars. This project was completed on time and under budget by nearly 100,000 dollars.

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United Technologies Aerospace Systems, Fairfield, CA 2018-2018 Senior Supervisor, Operations (Aerospace Optics), Mar-July Responsibilities include overseeing daily activities of 20 assemblers in multiple operation lines (cells) for the purpose of manufacturing energetic (explosive) material used in the aerospace and defense industry. Ensure complete adherence to all safety practices and standard operating procedures by all direct reports. Collaborate with cross-functional groups (planning, purchasing, engineering, testing, and shipping/receiving) and utilize Lean/Six Sigma tools and methodologies to identify continuous improvement opportunities and to ensure daily KPIs such as daily productivity, utilization, and first pass yield are met.

Sabbatical Nov-Mar 2017-2018

Genentech, Vacaville, CA 2009-2017

Manufacturing Senior Supervisor (downstream),

Responsible for the direct oversight of a cGMP biopharmaceutical manufacturing operation with emphasis on chromatographic separations, filtration & concentration operations, as well as buffer and solution preparations. Was given responsibility over a shift of 14 senior technicians with the second lowest performing statistics in the department and managed them to the top performing shift (as verified by yearly “actions performed” metrics) in the span of eight months. Served as a leader outside of immediate role in regards to process and system optimization, driving continuous improvement projects, and participating in cross functional and cross business collaboration and teamwork. Operated as department liaison for health authority audits. Lead FDA and EU tours of the facility and represented the department during audits as a presenter and as a data collector. Department change champion for a multi-million dollar facility overhaul project stemming directly from an FDA audit warning letter (that successfully resulted in zero further related findings from any health authority agencies during my tenure).

Chiron Corp / Novartis Corp, Vacaville, CA 2001-2009 MFG Technician III (upstream/downstream)

Worked directly with a range of both upstream and downstream bioprocess technologies following aseptic techniques and procedures in a cGMP environment.

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EDUCATION

Bachelor of Science in Business Administration

University of Phoenix, Phoenix, AZ

Associate of Arts with concentration in Foundations of Business University of Phoenix, Phoenix, AZ

Associate of Arts with concentration in Theological Education Trinity Biblical University

PROFESSIONAL DEVELOPMENT

Root Cause Investigation Training

Technical Assessor for Investigations Training

Roche Lean-DMAIC White Belt Certification

American Management Association Leadership Development TECHNICAL SKILLS

LIMs LabWare, SAP, PI, Visio, Microsoft Office, Office Suite, Word, Excel, PowerPoint, Oracle AFFILIATIONS

American Management Association

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