Job Details
About the Company: A biopharmaceutical company seeking expertise in the technical and application areas described in this position. The role offers a focused setting for translating specialist knowledge into research, engineering or organizational outcomes.
Target Candidates: PhD preferred in Pharmacy, Medicinal Chemistry, Pharmaceutics, Analytical Chemistry or Pharmaceutical Engineering.
Responsibilities
• Lead a small-molecule CMC team in drug-substance, oral solid dosage or analytical development.
• Develop API processes, formulations, analytical methods and quality controls for clinical and commercial needs.
• Coordinate technology transfer, registration documentation and cross-functional milestones.
• Resolve scale-up and consistency issues.
• The position links scientific or clinical needs with development, testing and application of the relevant technology. The work calls for careful documentation of evidence and coordination among research, product, quality or clinical colleagues as the project requires.
• Translate the stated responsibilities into clear work plans, review interim results against project objectives, and communicate progress, technical risks and next steps to the relevant team. Carry lessons from testing or implementation into the following development cycle.
Requirements
• PhD preferred in Pharmacy, Medicinal Chemistry, Pharmaceutics, Analytical Chemistry or Pharmaceutical Engineering.
• Small-molecule CMC, API, OSD or analytical-method development experience.
• CMC regulations, GMP, technology transfer and team/project management; international filings preferred.
• Candidates should interpret experimental or clinical evidence carefully, communicate limitations clearly and work effectively with specialists across the applicable research and development stages.
Highlights & Support: Internationally oriented innovative-drug platform with small-molecule CMC and regulatory responsibilities.