Skylar Wolfe Email & Phone Number

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

- Manage scheduling, scope, coordination, troubleshooting, and completion of clinical manufacturing at external partners (>22 million units per year) for OSD drug product and drug product intermediates. Includes on-time delivery/release of batches, full review/QA release, analytical testing, GMP compliance, and documentation. - Experience with multiple OSD equipment trains, scales, and tech transfers to sites.- Participate in quality audits to assess compliance to quality agreements and systems of clinical and commercial vendors.- Developed detailed time/event schedules to define, manage and track activities/ milestones related to outsourced demand. Execute all required SAP transactions such as goods receipt, virtual movements, and goods consumption. Utilizes SAP Engineering Change Management (ECM) to create, review, modify and approve Bills of Material (BoM) for long term and immediate demand.- Issue alert notices, conducts and documents investigations, develops and implements CAPAs using TrackWise software.- Track outsourcing spend and issues a quarterly analysis on YTD trends and compliance to budget.

Lawrence Township, Nj, Us

•Pediatric development lead for medicine of 1-6 years old, included drafting P3 sections of filing to US/EMA regulatory agencies, PAI readiness, manufacturing process validation, and commercial launch activities. Enabled acceleration of development activities and tech transfer allowed for validation and launch to be moved up ~ 6 months.•Additional development lead responsibilities include human taste assessment for sweetener/flavor selection, developing a robust commercial manufacturing process with non-platform excipients, and collaborated with biopharmaceutics group to develop a PBPK model for pediatric exposure, and successfully submitted data to FDA to waive a food effect study.•Experience with project management of outsourcing partners including development and commercial manufacturing•PMP certification (expected July 2017)•Pediatric drug development SME including taste assessment, multiple dosage forms, formulation and device design, and regulatory expectations. Member of IQ consortium pediatric working group. Member of AAPS patient-centric focus group•Experience using DoE and statistical analysis for data driven decisions•Formulation tem member on multiple drug product development projects which included manufacturing in numerous unit operations, troubleshooting sticking and compaction risks, and introducing solution to team mitigate disintegration issues. Experience with developing drug product using spray dried dispersions and co-processed material•Departmental lead on new knowledge management technology, including creating, testing, and implementing a software solution to better share knowledge across greater department. Led efforts led to design workspace that allows for flexibility in workflows and aligns with all scientific functions. Also one of development leads on restructuring sample submission for GMP and GLP samples.•Brought in-house an external lubrication option on Stylcam to enable small scale development to mitigate sticking risks.

Lawrence Township, Nj, Us

• Led activities for pediatric product development including ruggedness studies to establish acceptable material ranges, scale-up, and manufacturing of registrational stability batches at commercial site. Presented robustness findings at external meetings. • Managed multiple outsourcing teams including development, clinical manufacturing, and stability• Successfully gained endorsement of risk-based commercialization plan through internal governance• Represent drug product development on full integrated development team and provided input to numerous facets of development. Worked on regulatory filings for change in manufacturing process to reduce manufacturing risks.• Member of roadmap team that developed and successfully launched an in-house solution to manage project snapshots and departmental knowledge while improving project status transparency to management• Lead efforts to design a project summary form that will capture project data for future use and have improved usefulness to management for project planning.• Designed a novel software system to manage knowledge and workflows across all of greater pharmaceutical development• Founded and lead the pediatric community of practice, which included bringing in external experts and vendors to discuss pediatric formulation options.• Project lead for developing a tablet press method with external lubrication for clinical and commercial manufacturing.

Lawrence Township, Nj, Us

• Technical lead for a pediatric formulation that includes leading an outsourcing team, interacting with clinical and regulatory groups for filing amendments and investigator brochures, planning DoE process development activities, and developing a new manufacturing process that was successfully used for clinical manufacture• Formulation experience in multiple unit operations including active coating, roller compaction, high shear wet granulation, blending, and compression• Completed study to determine effects of porosity on tablet dissolution using mercury intrusion porosimetery which lead to improvements in the commercial product and successful re-validation• Member of bilayer and coating minipiloting teams which included intern mentorship, developing a model for predicting bilayer tablet delamination, and improving the understanding of the microenvironment in a coating pan• Member of roadmap team which remapped formulation workflows and captures data of key project decision points• Led the focus group sub-team in the departmental continuous improvement efforts, which resulted in projects that saved over $200,000 in 2013 and improved workflows in project work.

Verona, Vr, It

• Chemist specializing in polymorph, salt, cocrystal, stable form, and amorphous dispersion screening in GMP environment, focusing on solid state relationships and drug product development including manufacturing scale-up• Designed crystallization process and scale up procedure for a multi-component API approved for commercial use• Generated protocols and lead projects for solid state research encompassing experimental design, execution, problem solving, and managing a budget• Carried out independent research projects on novel polymorph systems, thermodynamic relationships, solution stability of cocrystals, and generation of cocrystals by compression• Lean Six Sigma Green Belt, leading projects for reducing timelines, increasing revenue, and improving scientific reports and services to clients, resulting in $189,000 yearly savings and revenue increases• Mentored two green belts on projects including employee training and lab 5S

Verona, Vr, It

• Bench chemist performing solid state screening, form selection, and crystallization development• Developed a high throughput plate screen for a UV-Vis spectrophotometry method to determine equilibrium solubility in multiple solvent systems• 11 SPOT awards for exceptional laboratory work• Acquired skills include analysis of drug substances via XRPD, hot stage microscopy, HPLC, DSC,TGA, moisture sorption, UV-Vis spectrophotometry, and 1H NMR

New York, New York, Us

Studied effect of increasing shear force in dissolution for improved IVIVC on controlled release tablets.

New York, New York, Us

Researched new mechanism of amine drug oxidation due to single electron transfer and visualization through fluorimetry.

New York, New York, Us

Investigated the effect of sonication on drug molecules due to free radical oxidation. Determined better sample preparation procedures to prevent form changes during formulation.

Bachelor'S, Pharmaceutical Sciences

Master'S Of Engineering, Pharmaceutical Engineering