Senior Analytical Chemist in Pharmaceutical Methodology, Stability Program Design and Data Visualization with 30 years of experience in the CMC sector

Sue Long

Susan is an expert in both ICH and Emerging Markets including market-specific CMC requirements for global markets. Her primary expertise lies in the analytical deliverables needed to support drug product registration in the US, EU, and EMAP markets.

She has extensive knowledge of the technical and regulatory requirements of the analytical content for many dosage form dossiers including instant and modified release solids, soft gels, liquids, suspensions sterile injectables, single entity and fixed dose combinations.

Susan holds a bachelor’s degree in Chemistry from Wake Forest University. She has held analytical positions with increasing levels of responsibility at both Burroughs Wellcome Company and GlaxoSmithKline. Her most recent position held was Director, Emerging Markets R&D where she had oversight of teams in RTP and Singapore. Prior to this position, Susan was a CMC lead for early phase programs.

Examples of projects completed:

  • Fixed dose combination tablet manufactured in India. Successfully led an international team of CMC scientists, resulting in the filing of an EU dossier.
  • Fixed dose combination tablet developed in Singapore. Partnered with the government of Singapore to train analytical scientists to develop and validate fit for purpose analytical methods and stability programs.
  • Soft gelatin drug product manufactured in Japan. Successfully let an international team of CMC scientists, resulting in multiple international files in support of clinical studies.
  • Single entity liquid formulation manufactured in the UK. Successfully led an international team of CMC scientists, resulting in US and EU registrations and approvals. Also acted as the CMC representative for a successful FDA pre-approval inspection.