Philip Glover

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.

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%.

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. 

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. 

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. 

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.