Andrea excels in supporting our clients during drug development of small molecules, biologics and biosimilars through all stages, from preclinical through approval and product lifecycle management with a focus in CMC.
Key Areas Of Expertise
- CMC leader with expertise in analytical and quality supporting the development of both small and large molecule therapeutics
- Highly skilled at authoring CMC sections of INDs, IMPDs, NDAs, BLAs and regulatory responses in global markets
- Thorough knowledge on FDA, GMP, GLP and ICH regulations and guidelines for drug development
- Analytical characterization, method development, method validation and method transfer for small molecules and biologics in solid dosage forms and injectables
- Extensive experience in ICH Stability study design, shelf life determination and testing
- Specification establishment and justification
- Compliance including quality management, audit readiness, lab investigations, gap assessments and data integrity
- Project Management of cross functional project teams
Andrea was the Head of Compliance for Quality Control for Specialty R&D at Teva Pharmaceuticals. In this role, she was responsible for data integrity and overall adherence to GxP for the Quality Control team. During her 22-year tenure at Teva (and its legacy company Cephalon), she held a variety of roles. She was the Head of Quality Control responsible for the release and stability testing of drug substance and final product in support of clinical and commercial programs including but not limited to medical devices, autoinjectors, prefilled syringes, lyophilized products, capsules and tablets. She was also a CMC leader where she was responsible for authoring, reviewing and finalizing the CMC sections of multiple regulatory submissions including INDs, BLAs, NDAs and regulatory responses. She has also supported several PAIs.
Andrea has a PhD in Analytical Chemistry and more than 20 years of experience as a CMC leader in the pharmaceutical industry.
Dr Andrea Pless