Scott Cheeseman Email & Phone Number

Greenfield, In, Us

Greenfield, In, Us

Brentford, Middlesex, Gb

Served as an asset specific technical leader in a production value stream (upstream and downstream), by driving all aspects of technical readiness, troubleshooting, and continuous improvement, and influencing platform definition and future technical strategy inside UM Biopharm and within the larger MSAT and technical community at GSK. Supported technical capability development for the site MSAT team.• Delivered new product introduction and robust commercial manufacturing support including PPQ for biopharmaceutical products right-first time, with increased speed, reliability (no major deviations), and productivity (titer increase vs clinical campaign) leading to the first successful PPQ in a new BioPharma NPI facility, meeting all PPQ protocol requirements and quality release requirements.• Led talent development for direct and indirect reports (up to 20), developing the right technical, leadership, and behavioral skills to create an energized, inspired, and motivated team/organization. Weekly 1:1 for contracting and employee development.• Managed relationships with key internal (i.e., production, engineering, quality) and external (i.e., central and external MSAT teams, R&D) partners to deliver and drive innovative technical objectives and strategy, including digital and analytical technologies. Led weekly upstream and downstream technical meetings during PPQ manufacturing campaign.

Brentford, Middlesex, Gb

Provided leadership and technical expertise to all of Engineering Operations and EHS at the site. Served as Site Process Safety SME and as interim Critical Utilities Associate Director, leading a team of 12 engineers. • Led the site-wide recommissioning of the LSM Alcohol (IPA) distribution system used for contract manufacturing, ensuring all systems were Class I Div. II as needed resulting in a safe production facility.• Oversaw the site-wide education process for handling flammable solvents.• Developed basis of safety for safe IPA handling and waste collection requirements paving the way to a successful contract manufacturing campaign for an external client.

Brentford, Middlesex, Gb

Led Process Engineering Team of 18 to support new product introductions, manufacturing, capital projects, compliance, and all process changes and improvements in a 2-value stream biopharm facility.• Developed high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.• Guided, mentored, and coached staff to gather data on operational problems, support generation of possible solutions, and the selection and buy-in of the final solution, ensuring the solution was implemented appropriately and satisfies the customer’s requirements.• Increased process safety awareness and capability as leader of site wide initiatives.• Interfaced with Environmental, Health and Safety, Technical, Production, Quality, and Corporate Engineering groups, assuring each project conformed to approved user requirements.• Managed team in the maintenance, repair, and alteration of process systems such as bioreactors, centrifuges, chromatography systems, ultrafiltration units, sanitary vessels, and sanitary piping networks.• Led the >$5M capital project to implement facility changes for the aBCMA (belantamab) cell culture and purification asset improvements.• Directed and supervised a team of process mechanics responsible for strategizing, provisioning, and coordinating the execution of approximately 2000 annual work orders, managing a spare parts inventory exceeding $1 million, ensuring seamless operational continuity and efficient resource utilization.

Brentford, Middlesex, Gb

Managed all aspects of the technical design and implementation of continuous processing capability in an API Pilot Plant in addition to providing day to day technical oversight of all process engineering activities in the plant. • Led the commissioning and validation activities required for swift, flexible GMP and Developmental processing.• Led the culture change required to transition the mindsets of a plant previously focused on the value-stream of traditional batch processing to that required for knowledge capture and proving continuous processing capability.• Successfully demonstrated the continuous plant via completion of a multistage continuous processing campaign leading to successful tech transfer and drug approval in Japan and the United States.

Rahway, New Jersey, Us

Managed the pilot plant implementation of Merck Production System (MPS) elements aimed at improving operational efficiency while managing the technical requirements necessary to scale up a manufacturing process requiring batch and flow chemistry. • Developed and implemented the value stream map for tracking the flow of material and process knowledge information in the pilot plant.Conducted enrollment training sessions with both salaried and hourly staff (approximately 30 staff total) to educate the workforce on the mindsets, management systems and tools required to implement the Merck Production System. Led the development of visual management boards utilizing the value stream map.• Created process procedures and batch sheets for the use of a new pilot scale flow reactor capable of multiple temperature zones and residence times. Completed the operational qualification (OQ) for the new pilot scale flow reactors. • Worked as a team with project Organic Chemists to implement improvements. Configured flow reactor to provide process information not available in laboratory setups. Improved yield by controlling reaction temperature at cryogenic conditions (-30 °C to -40 °C). Included use of online Process Analytical Technology (PAT) such as HPLC analysis and FTIR analysis in the process flow to provide immediate and continuous feedback of purity and extent of reaction. Configured process flows such that four streams flowed in a controlled manner simultaneously, including highly toxic materials, with multiple temperature control zones.• Completed Process Hazard Analysis (PHA) revalidations.

Rahway, New Jersey, Us

Project leader managing the development and implementation of a site-wide aptitude assessment (over 300 union employees) that increased the success rate of senior qualified candidates selected into skilled positions. Simultaneously developed and implemented a training and assessment program for research chemical operators, mechanics of various trades, laboratory animal specialists and fire technicians that required demonstration of proficiency for job retention.• Negotiated the change with Union Management (common success criteria). Developed the high-level design of the program including incorporating the program requirements into the contract with the collective bargaining unit (Inclusion). Conducted a job analysis with Select International (expert vendor) for all skilled labor positions. Directed the efforts of job-content-experts and created sub-task guides, standard operational guidelines (SOGs), competency-based training manuals (CBTs) and training batch sheets for all chemical operator core skills as defined by the selection and development program: temperature control, pressure control, feed control, bottoms control, vacuum distillations, batch filtrations, solids charging and liquid charging. Directed similar activities for mechanics, lab animal specialists and fire technicians. Communicated program implementation to site leadership through the labor relations committee, town hall meetings, on-site publications, and orientation sessions. Successfully implemented core skills assessment program across all pilot plants with a 100% completion rate. Transferred sustaining responsibilities to the shop floor supervision and management.

Rahway, New Jersey, Us

Progressed through roles of increasing responsibilities leading teams of up to (32) chemical operators and (6) shift supervisors for 2-shift/3-shift facilities, with (4 -10) production areas: chemical processing bays and modules each equipped with (4-5) reactors and (3) tanks (20–2000-gallon scale). • Partnered with organic chemists and process engineers to produce process intermediates and pure active pharmaceutical ingredients (API).• Approved all technical process documentation for GMP process introduction into the facilities. Process chemistry descriptions, specific process safety concerns, process flow diagrams, PHA and PSM elements, and environmental air permits.• Specific attention paid to potent compound or highly toxic hazardous material (HTHM) processing. HTHM examples: Thionyl chloride, Sodium cyanide, Trifluoroacetic anhydride, Borane:THF.• Created process procedures and batch sheets for new equipment and technology in the pilot plant. Examples: solids charging systems for industrial hygiene considerations, Heinkel centrifuge with CIP system, Ferrum centrifuge with CIP system, multi-fluid solvent distribution system, process venting requirements for vessel and solids charge chute CIP cleaning. • Led start up team of (2) engineers and (1) shift supervisor to commission the clean-in-place (CIP) system for equipment cleaning, including reactors, tanks and auxiliary equipment during the facility start up. Authored and executed all batch sheets for pre-operational activities (POA) and operational qualification (OQ) of the Clean-in-Place system.• Implemented P&ID-based change documentation program.• Led the design, P&ID reviews and Process Hazard Analysis (PHA) sessions for new production equipment.• Member of labor relations committee representing R&D and participated in bargaining and negotiations with union workforce leaders. Responsible for grievance resolution including written responses, grievance hearings and arbitrations.

Rahway, New Jersey, Us

Led technical coordination of lab development and processing for a multi $ billion drug Singulair. Worked directly with process chemists and other engineers to develop and demonstrate engineering scale-up specifications for various synthetic organic chemistry steps at pilot plant scale. Led and managed the technical transfer and process demonstration at the manufacturing facility for processing steps including isolation of API.