Ambitious, conscientious professional with comprehensive laboratory and manufacturing experience at large and small, family - style organizations. Eager to learn new techniques, continuing my career in pharmaceuticals. Excellent project management skills, coordinating scientific studies independently and in collaboration with multi-disciplinary project teams, driving adherence to budgets and timelines. Adept in regulated environments. Articulate and engaging. Experience working with controlled substances.
- Skilled researcher
- Problem solver
- Product/method development
- Practical ingenuity
- Innovative, quality-focused, and goal-oriented, demonstrating perseverance to achieve desired outcomes for customers.
- Polymorph screening (solid form screening), including stable form screening and hydrate/solvate determinations
- Challenging crystallization, including single crystal growth for structure determination
- Salt/cocrystal screening
- Amorphous material generation
- Solubility determination
- Wet chemistry techniques, organic and inorganic, including titration, extraction, and pH adjustment
- Rotary evaporation, distillation, lyophilization, and loss on drying
- Formulation preparation and testing, including amorphous dispersions
- Experience with small and large molecules, including controlled substances, teratogens, cytotoxics, and moisture or light-sensitive materials
- Atomic absorption | Optical microscopy, including hot stage | GC/MS | IR | Raman
- Thermal analysis, including DSC and TGA | XRPD | Micro VanKel dissolution
- USP VanKel dissolution, including initial instrument setup and automated testing using UV flow cell; paddle, basket, or intrinsic, including pellet pressing (Woods apparatus);
- UV-VIS (spectrophotometer), pH meter.
Microsoft Office (Word, Excel, PowerPoint, Outlook) | Omnic | Grams | ACD Labs | ChemDraw PatternMatch (proprietary) | Mercury | PowderCell | UN-SCAN IT | StarLIMS |MiniTab
- Collected and interpreted analytical data for drug substance and drug product, readily making connections between the data about the nature of the materials tested.
- Conducted independent research on novel cocrystals and ‘crystalline sponges’, for structure determination of hard-to-crystallize materials, including liquids
- Discovered numerous new materials, resulting in enhanced stability or solubility of drug substance and IP protection for clients.
- Planned and executed scale-up for generation of several materials, allowing for more complete characterization and providing crystalline seeds for clients to produce newly discovered materials.
- Prepared crystals leading to structure determination which verified new crystalline phases.
- Determined API chirality for enantiomers or diastereomers prepared from complex synthetic pathways.
- Increased understanding of material properties, particularly solvent interactions.
- Engaged in various forums for discussion of specific projects and methods as well as CMC and regulatory requirements.
- Active collaboration with inter-departmental and cross-functional groups, completing multifaceted projects efficiently.
- Advised and trained colleagues on specific techniques, increasing their efficiency in project completion.
- Regular thorough, consistent review of colleagues’ documentation for cGMP compliance.
- Created reports for clients to provide material understanding and sections for patents and FDA filings.
- Dedicated to finding solutions for clients, focusing on identifying best solids for advancement and providing insight into process conditions, thereby reducing costly manufacturing issues.
- Frequent customer interaction, leading conference calls.
- Persuaded clients to expand/change project scope and/or to change process or target solid form of API, when appropriate, based upon my scientific judgement and team consensus.
- Developed quantitative analysis method for percent crystallinity of drug substance through XRPD.
- Planned and performed stability studies on drug powders in to their change in crystallinity or polymorphic form, as measured by DSC and XRPD.
- Aided in salt and form selection for drug candidates.
- Prepared and tested parenteral drug product formulations.
- Engaged in troubleshooting of manufacturing problems for prototypes as well as mass-produced current products.
- Maintained various records, including repeatability studies, calibration records, and Safety Data Sheets.
- Led discussions for the safety program.
- Statistical tracking of measurements for repeatability and accuracy.
- Prioritized testing of samples according to hold time and testing efficiency.