Ashley Daugherty Email & Phone Number

West Columbia, South Carolina, Us

• I am responsible for the management of analytical laboratory operations, laboratory quality systems, product development, formulation, and stability teams.• I serve as a member of the executive team that sets the company’s strategic direction for Product Development.• One of my key assignments is leading all aspects of product pipeline and pharmaceutical development, including API selection, sourcing formulation development and optimization, analytical methods development and validation, methods transfer, CMC, scale-up, stability studies, management and distribution of clinical supplies, and preparing CMC sections for regulatory filings.• I ensure process and performance improvement by delivering technical leadership site-wide to support current commercial drug product manufacturing and pipeline product development.• Spearhead Analytical and CMC projects in support of NDA and ANDA projects with a keen focus on inhalation, injectable and ophthalmic dosage forms.

West Columbia, South Carolina, Us

• During this tenure, I was entrusted with directing all facets of QC and R&D chemistry laboratories, stability programs, and product development to achieve optimum outcomes.• I was involved in the preparation and approval of CMC sections of regulatory filings including ANDAs and NDAs.• Along with many other functions, I led drug development spanning preclinical development through post-commercialization.• I improved overall efficiency and effectiveness by identifying and resolving issues associated with formulations studies and R&D manufacturing.

West Columbia, South Carolina, Us

• In this role, I gained excellent results by administering staff of the analytical services and product development organization.• I ensured the achievement of departmental and company goals by mentoring team members and removing obstacles.• I gained a thorough grasp of analytical techniques used for qualitative and quantitative analysis of drug substances and drug products, such as HPLC, LC-MS, GC, FT-IR, DSC, UV-VIS, and ICP-MS.• I engaged myself in planning and directing method development, validating and testing, formulation development, and driving cGMP activities.

West Columbia, South Carolina, Us

• I was responsible for supervising and leading a team of 10+ scientists to ensure continuous performance improvement.• I complied with organizational policies and procedures as well as regulatory standards, while managing Quality Control and R&D chemistry laboratories.• I also designed and directed method development, validation, and testing for development and commercial cGMP activities.• Assist staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results.

West Columbia, South Carolina, Us

• I was tasked with conducting Quality Control and R&D chemistry analytical testing.• I provided unprecedented assistance in analytical method development, transfer and validation work.• Engaged myself in leading project assignments to comply with quality planning and product specifications and manufacturing standards/methods.

Atlanta, Ga, Us

Engineered Old Yellow Enzyme by circular permutation for biocatalysis applications.Developed analytical and biochemical methods to separate and identify small molecules of interest via GC, HPLC, UV-Vis and fluorescence spectroscopy.Rationally designed therapeutic proteins for prodrug activation.Computational design of inhibitory peptides for proteases.

Spartanburg, South Carolina, Us

Improved the formulation of dyes to generate indirect material cost savings for the plant.Maintained regulatory chemical information/database.

Frankfurt, De

Conducted organic synthesis and process development research.Assisted in lab projects to improve productivity in plant operations.

Doctor Of Philosophy (Ph.D.), Chemistry

Bachelor Of Science (Bsc), Chemistry