Ayesha A. Email & Phone Number

Raritan, New Jersey, United States

New Jersey, United States

• Develop and write investigations, deviations, and quality events to ensure adherence to company policies and regulations• Oversee the implementation of corrective and preventive actions (CAPAs) to ensure effective resolution of issues and maintain quality standards• Manage laboratory change controls to ensure procedures are followed and to minimize risks• Revise Standard Operating Procedures (SOPs), forms, work instructions, and other documentation to maintain high quality standards and ensure clarity of procedures• Participate in audits of laboratory areas, systems, and procedures to assess compliance and identify areas for improvement• Develop and deliver training to laboratory personnel to maintain awareness and ensure adherence to policies and procedures• Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Manufacturing, and Development, to ensure laboratory operations are aligned with company goals and regulatory requirements• Work with the QC Review and Document Control teams to ensure all laboratory testing and support documentation is reviewed, closed out, and archived within appropriate timeframes• Identify areas for continuous improvement in laboratory operations and procedures and propose solutions to increase efficiency and reduce risks• Monitor and report on laboratory metrics to ensure quality standards are met and any issues are addressed in a timely manner• Provide guidance and support to laboratory personnel on quality-related matters

Edison, New Jersey, United States

• Performed analytical testing of in-process (IP), finished products (FP) and stability samples (ST)• Followed Analytical Methods, Good Manufacturing Practices (cGMP), Protocols, Standard Operating Procedures (SOP) and company policies• Performed testing of IP, FP and ST samples including dissolution, assay, impurity, content/blend uniformity, water content, forced degradation, particle size distribution and bulk and tapped density according to analytical methods and United States Pharmacopeia (USP) in a regulated laboratory environment• Performed wet chemistry including preparation of sample, buffer, mobile phase, diluent, dissolution medium and standard solutions, and pH testing of buffer. • Operated general analytical instruments during FP and ST sample testing such as High Pressure Liquid Chromatography (HPLC), Dissolution Apparatus, Karl Fisher Titrator and FTIR spectrophotometer.• Performed Total Organic Testing (TOC) and Conductivity tests on water samples to determine suitability of water for manufacturing and quality processes• Performed cleaning validation/verification of manufacturing equipment • Identified and troubleshot issues with instrumentation and analytical preparation• Managed calibration and maintenance of laboratory equipment to ensure compliance with GMP and GLP• Labelled, transcribed and recorded documentation such as report sheets and laboratory notebooks in compliance with SOPs and GDP• Reviewed raw material, IP, FP and ST sample test reports and documentation recorded in laboratory notebooks• Performed inventory management and placed purchase orders for chemicals and reagents

New Jersey, United States

• Investigated the impact of residual crystals on particle size growth in amorphous solid dispersions to define strategies to enhance aqueous solubility of BCS Class II drugs by optimizing ASD formulation• Developed wet stirred media milling approach for production of micro and nanoparticle suspensions of BCS class II drugs• Prepared amorphous solid dispersions via spray drying and characterized solid state of the formulation via differential scanning calorimetry (DSC)• Performed dissolution tests (USP II) to evaluate the impact of particle size on saturation solubility and dissolution rate• Analyzed the effect of micro- and nanocrystals on ASD drug release using UV-Vis spectroscopy and particle size using laser diffraction and dynamic light scattering (DLS) • Involved in troubleshooting content uniformity assays and maintenance of spray dryer & stirred media mill• Followed laboratory safety procedures in accordance with SOPs and regulatory guidance• Documented and reviewed results and reports in accordance with laboratory guidelines

Master Of Science - Ms, Pharmaceutical Engineering

Bachelor Of Science - Bs, Biomedical Sciences, General