Anthony Moffa Email & Phone Number

API Technical Operations

API Technical Operations

Waltham, Ma

Developed a recrystallization to control particle size of an active ingredient in a direct compression formulation, and successfully scaled process up to pilot and production scalesParticipated in technology transfer to CMO and monitored process on site, providing input to production engineers and operatorsSupported documentation for recrystallization development and technology transfer in preparation for process validation including review of batch recordsManaged the purchase of capital equipment by writing user requirement specifications, soliciting quotations from vendors and managing vendors throughout the purchasing processManaged purchase of pilot scale drug product equipment from user requirement specification and vendor evaluation through commissioningSupported development of a direct compression bilayer solid oral dosage product and corresponding analytical methods by preparing blends and manufacturing tablets on a compaction simulator to support analytical method developmentServed as a controlled substance responsible person, ensuring compliance with controlled substance regulations by lab usersWorked closely with other development groups as well as manufacturing, operations and quality to achieve development goals

Waltham, Ma

Supported development of a direct compression bilayer solid oral dosage product manufacturing processDetermined grade and level of excipients in active and placebo blends by analyzing segregation, flow and compaction properties of blendDetermined compression process parameters for manufacture of direct compression bilayer productDe-risked API particle size variability for direct compression productProficient in use of drug product equipment including powder blenders, rotary tablet presses and compaction simulatorDeveloped a recrystallization to control the particle size of an active ingredient in a direct compression formulationServed as a controlled substance responsible person, ensuring compliance with controlled substance regulations by lab usersWorked closely with other development groups as well as manufacturing, operations and quality to achieve development goals

Lexington, Ma

Assisted in the development and manufacture of spray dried inhalable powders for preclinical useAnalyzed powders for volume particle size distribution by RODOSAnalyzed the solid state properties of powders using thermogravimatric analysis and differential scanning calorimetry

Greater Boston Area

Developed an assay for the quantification of starch in microalgae culturesAssisted in optimization of microalgae cultures to be used for the production of biodiesel

Bedford, Ma

Assisted in formulation development of drug loaded and placebo microparticle formulationsManufactured hydrogel punctum plugs with microparticles or micronized drug using proprietary PEG technologyCharacterized punctum plugs and microparticles using various tests such as in vitro release and particle size distributionAssisted in the manufacture of preclinical material in environmentally controlled areasAssisted in the development and optimization of assays for future use by the analytical groupAnalyzed, summarized and presented data from various projects

Cambridge, Ma

Managed extensive small scale cell culture experiments in shaker flasks Managed cell culture experiments in five liter glass bioreactors with controlled dissolved oxygen and pHInitiated and maintained cell cultures in WAVE disposable bioreactors at five, ten and 25 liter scale and Single Use Bioreactors at the 50 and 250 liter scaleAssisted in GMP manufacturing campaign to make material for clinical trialsMaintained a detailed laboratory notebookPrepared a technical presentation for company lab meeting

Watertown, Ma

Participated in formulation and small scale manufacture of sterile nanoparticle vaccines for use in animal studiesAssisted in evaluation of custom equipment for use in process optimization and batch scale up to support future clinical manufactureRevised and drafted new Standard Operating Procedures for specialty equipmentWorked closely with the Chemical Hygiene Officer to maintain chemical inventoriesMaintained a detailed laboratory notebookCoordinated across multiple departmentsPrepared a technical presentation for the company end of year meeting