Marc Thomas Email & Phone Number

San Diego, Ca - California, Us

- Manufacturing best practices- Experimental design for Upstream and Downstream process development- Competent cell manufacturing- Technical transfer and scale-up - cGMP documentation review- Chemistry, Manufacturing and Controls (CMC)- Technical Writing- Investigative new drug (IND) Documentation- Slayer of bacteriophage

Hatboro, Pennsylvania, Us

- Team manager for site operations, facilities, client operations and validation- Development and maintenance of metrics/KPI's- Oversight of preventive maintenance, validation, calibration and equipment repairs- Creation and review of GMP documentation including deviations, CAPA's, change controls, validation protocols, reports, equipment SOPs, etc. - Development of process based operations based on best practices - cleanroom cleaning, gowning practices, 5S, Kanban, continuous improvement- Cleanroom and Equipment Qualification- Oversight of ISO8 and ISO7 cleanrooms: cleaning, maintenance, environmental monitoring, etc.- Conduct and coordinate Qualification (IQ, OQ, PQ) Activities: Document, Review, Execution- Oversight and improvement of Computerized Maintenance Management System (CMMS)- System owner and Administrator for Computerized Maintenance Management System: Training, Document Creation, Data Validation

Bubendorf, Ch

- Production Planning/Scheduling: Coordination and alignment with Facilities, Materials Management, Engineering, QC, QA and Production to create integrated production schedule- Mediator/communicator to resolve scheduling conflict in a mutually beneficial manner- Creation and maintenance of KPI's: schedule adherence, monthly deliverables, annual forecast- Capacity planning/Modeling- Continuous improvement to improve scheduling, increase capacity, optimize throughput, etc.- Root Cause Analysis : DMAIC, Five whys, etc. - Validation Project Oversight; Cleaning Validation, Hold-Time- Technical Transfer- Technical document drafting/revision- BSD Operations Lean Champion/Lean Leader: Process Design, Process improvement: 5S, Kanban, 6-Sigma- Internal training for process updates, tech transfer, etc.- Good Practices (GxP) quality guidelines including GMP, GDP & GLP

San Diego, Ca, Us

Managed multiple projects focused on discovering unique therapeutic molecules, spearheaded partnerships with Contract Manufacturers (CMOs), developed and executed bacterial expression experiments for target molecules.Developed improved documentation to assist in the technical transfer to CMOs, identified relevant experimental data, and presented analysis and proposed outcomes and to stakeholders to gain buy-in; enabled quicker and more effective transfer, eliminating many technical problems and oversights, and improved team collaboration to minimize redundancies. Provided technical project oversight for Chemistry, Manufacturing, and Controls (CMC) for programs, led development of new conjugated Fragment Antigen Binding (FAB), outlined project requirements, developed technical timelines, and designed experiments related to protein expression, protein purification, and downstream processing; leadership reduced delays due to technical oversight and improved QC and manufacturing actions. Served as Production Lead and Lab Manager for large-scale (≥2L) bacterial expression of target proteins, created improved platform fermentation methods for future development, and oversaw expression process; able to improve output volume, freed up needed manpower for development of target proteins, and implemented new, more effective approach. Led project to improve periplasmic expression level of target FAB for a conjugated protein product from ≈200 mg/L to 500 mg/L.Improved periplasmic expression level of second target FAB from 10 mg/L to over 200 mg/L.Managed re-launch of fermentation suite, performed inventory and tests of equipment, repaired machines, reorganized lab layout, and created updated training and documentation.Led fermentation methodology and equipment trainings, developed technical documentation, and delivered demonstrations.

San Diego, California, Us

Led design and execution of experiments for the development of therapeutic proteins; directly partnered with teams to develop and test experiments, conducted analysis, and communicated with CMO’s to assist in technical transfer. Served as Upstream Technical Lead in transfer to CMO, reviewed and analyzed data for confirmation and communication to stakeholders, traveled to production sites and worked directly with technical teams, and provided oversight to manufacturing process to ensure proper execution. Spearheaded new partnership between Protein Production and Discovery groups to assist in internal manufacturing of target proteins; new collaboration enabled expression of 32 proteins, shift priority to new, more complex projects, and improved timelines. Led development of new fermentation process that improved soluble protein expression 16x, from 0.5 g/L to 8 g/L, and factorial experimentation that improved inclusion body protein expression 2.5x.Developed documentation and reports for preparation of IND filings and FDA approval, responsible for process development documents, recorded design, isolation of production strains, and final experimentation and manufacturing processes; ensured zero delays in approval.Led efforts to improve product homogeneity by minimizing translational and post-translational modifications caused during upstream expression; able to express and purify protein with greater than 90% homogenieity. Oversaw implementation of response surface methodologies for medium development to improve wet cell weight of various E. coli strains from ≈100 g/L to >400 g/L.Co-developed RP-HPLC titer assay for measurement of target protein from fermentation broth, improved purification process yield from <50% to >65% of total available soluble protein.Contributed to launch of new automated database and barcode system; eliminated use of paper, improved collaboration with real-time data access, and provided greater transparency to experiment progress.

Waltham, Ma, Us

Served as Technical Project Lead and acted as liaison between R&D and manufacturing teams to assist in the transfer of new processes, addressed process issues hindering success and transfer, and assisted with scale-up, optimization, and QC method selection; improved 10% success rate to nearly 100% during tenure. Led and provided technical leadership to fermentation and competent cell teams, created new training program to educate team on the theoretical and scientific operation of fermenters, and coordinated monthly sessions with outside vendors for advanced equipment training. Served as Manufacturing Technical Team Lead for 10 Research Assistants in the production of over 1000+ fermentations of E. coli, P. pastoris and T. aquaticus. Spearheaded fermentation lab redesign, created new lab layout including equipment selection and location, served as part of team that executed validation plan to test all aspects of new lab, and identified vendor for production materials incase of failure.Developed improved ranking tool to assist with determining process development opportunities for current manufacturing processes; enabled the use of hard data related to variance, process success and failure, and backorder rates to identify priority processes and improvement frameworks.

Assisted in 500+ fermentations of Actinomycetes and Bacillus at 10L – 5000L scale and the process transfer to manufacturing facility to a scale of 35,000L.Project leader to optimize continuous fermentation process of an immobilized cell line and separate fermentation process that improved expression of beneficial natural products.