Philip Glover
Research and Development Consultant
Versatile consulting engineer with a decade of experience applying scientific methods to enhance complex processes and resolve nagging problems. Skilled in defining client needs, aligning business requirements, and executing sustainable, innovative, and positive change. Diverse hands-on research experience at all scales of development, from lab bench to commercial platforms. Practiced in product development, tech transfer and scale-up of emerging technologies, and establishing process controls. Specialist in the application of rheological and interfacial properties to dispersion and atomization operations. Expertise in particle engineering for medical technologies. Adept at communicating with technical and non-technical audiences.
Skillset includes:
Development
Design of Experiments (DOE)
Process Development
Analytical Development
Quality by Design (QBD)
Technology Transfer & Scale-up
Manufacturing
Equipment Design
Process Control
Continuous Improvement
Good Manufacturing Practice (GMP)
Clinical Trial Manufacturing
Management
Supplier Management
Project Management
Statistical Analysis
Regulatory Applications
Professional Experience
Alcresta Therapeutics • Waltham, MA
November 2020 to March 2023
Sr. Engineering Program Manager
Engineering manager of the iLipase development program, coordinating internal and external activities for the submission of a Food Contact Notification (FCN) for Alcresta’s next generation of Immobeads and iLipase. Defined iLipase specifications and managed production of material suitable for use in design verification and validation lots for Alcresta’s next generation RELiZORB medical device. Managed analytical method development and validations to demonstrate Immobeads and iLipase material as suitably pure for use in RELiZORB.
Key Accomplishments:
Conducted supplier investigations at multiple suppliers to improve product safety. Implemented process improvements and operational hygiene changes to eliminate >90% of extractable impurities in iLipase, reducing remaining concentrations below threshold of toxicological concern.
Improved enzyme immobilization through process capability studies, reducing enzyme loss from iLipase by 60% while maintaining 30 – 50% improvement in immobilized enzyme activity in simulated use testing.
Transferred Immobead production to newly constructed, dedicated manufacturing facility, managing supplier through the commissioning of all process equipment over a 3-month period without disruption to required production volumes to support commercial launch of next generation RELiZORB.
Performed engineering assessment of iLipase and RELiZORB device testing to define formula residence time requirements for future applications and treatment of an expanded patient population.
Downstream Engineering Program Manager
Managed small-scale process optimization and troubleshooting studies to support technology transfer to the commercial scale for next generation iLipase, a food contact substance-enzyme complex. Designed and coordinated experiments to support scale-up of production for next generation Immobeads, macroporous polymer beads for immobilizing enzymes. Coordinated engineering study across the entire supply chain to demonstrate design feasibility for the next generation RELiZORB device, a single-use lipid hydrolysis reactor to aid in fat digestion in patients with pancreatic insufficiency (EPI) and short bowel syndrome (SBS).
Key Accomplishments:
Managed new Immobeads supplier through commercial scale development, commercial facility construction, and quality management system (QMS) implementation on time and on budget over a compressed 15-month timeline.
Successfully applied DOE to scale-up of suspension polymerization by 3x’s and elutriation operation by 5x’s, increasing overall process yield by 20% and reducing fines in the particle size distribution by 80%.
Managed enzyme immobilization supplier through 2x scale-up of ion exchange chromatography and TFF based enzyme purification process and resolved inconsistencies in iLipase activity with small-scale troubleshooting DOEs.
Resolved iLipase particle aggregation issue induced from triboelectric static charge with formulation adjustment using materials native to the iLipase manufacturing process.
Improved in RELiZORB device filling accuracy through the application of static dissipating ionization equipment, reducing iLipase fill weight variability by 80%.
Pacira Pharmaceuticals • San Diego, CA
October 2015 to July 2020
R&D Engineer III
Led project team tasked with the containment of DepoFoam process, a multiple emulsion process with volatile compounds, with Highly Potent Active Pharmaceutical Ingredients (HPAPI) at the laboratory scale. Lead engineer defining and executing DepoFoam product development at bench, lab, pilot, and commercial scales. Provided small-scale experimental support and technical guidance to commercial EXPAREL product process launch. Identified and investigated process analytical technologies (PAT) for intermediate and product characterization.
Key Accomplishments:
Designed, procured, installed, and commissioned self-contained lab space for developing DepoFoam products with HPAPI on time and on budget. Utilized flexible containment for operations, process isolators, and clean-in-place capable production equipment with a capital expenditure of less than $500k in one year.
Redeployed HPAPI equipment in two weeks following company relocation and launch of new lab space.
Designed and implemented wash-in-place system for lab-scale vessels to mitigate HPAPI-related risk in cleaning procedures at a scale 3x’s smaller in volume than is conventionally considered viable.
Introduced QBD principles to Pacira’s product development, mapping process spaces with DOEs to improve process robustness of three DepoFoam Pipeline products, all in a 12-month period.
Developed novel process to match existing product attributes of EXPAREL commercial product and new capability to control drug release rate. Innovations enabled production of 50% more product on existing platforms or 50% more potent product.
R&D Engineer II
Developed DepoFoam processes at lab and commercial scales, producing toxicological and clinical trial materials to support DepoFoam market expansion, and deployed CFD simulations to double capacity of continuous DepoFoam production platform.
Key Accomplishments:
Reformulated DepoMLX product process to double potency of initially transferred formulation that was limited by aggregation-inducing processing issues at higher potency in a six-month period.
Coordinated and executed DepoMLX process development at commercial scale in subsequent three months.
Engineered development and production of clinical trial materials for DepoTXA pipeline product, scaling up production and developing process at commercial scale, and leading production of clinical trial materials within six months of starting role.
Bend Research • Bend, OR
March 2008 to September 2015
Research Chemical Engineer
Defined gas disperser design and spray dryer geometry, prototyping modular and rapidly deployable spray dried dispersion production platforms. Developed polymeric nanoscale dispersions for HPMCAS pseudolatex capsule production. Created predictive model for evaporative flash nozzle atomization. Designed equipment for commercial spray drying suites and implemented process improvements to pharmaceutical spray drying operations. Coded scripts and defined algorithm research for motion sensor data analytics for Nike+ products. Hands-on lab experience, prototyping Modular Automated Sampling Technology (MAST), automating aseptic vaccine bag filling machine procedures for non-sterile environments, and sequencing algorithms to maximize automated buffer production.
Key Accomplishments:
Architected, prototyped, and implemented novel spray dryer design for rapid usage; dryer produces equivalent amounts of product across existing platforms with 50% of normal operating footprint.
Transformed Niro PSD-2 spray drying platform to double throughput vs. conventional operations, also introducing innovative 3D printed secondary cyclone system to prolong usability of downstream process filter.
Engineering Intern
12 months of hands-on lab experience, prototyping Modular Automated Sampling Technology (MAST), automating aseptic vaccine bag filling machine procedures for non-sterile environments, and sequencing algorithms to maximize automated buffer production.
Key Accomplishments:
Prototyped valve designs, reprogrammed control logic, and performed reliability testing of Modular Aseptic Sampling Technology; automating aseptic sampling and increasing frequency to 30 minutes from 4 to 8 hours using manual sampling.
Education
Bachelor of Science in Chemical Engineering,
June 2011
Oregon State University • Corvallis, OR
Certificates & Licenses
Lean Six Sigma Green Belt, February 2019
UCSD Extension • San Diego, CA