Responsibilities

 • Critically review data from contract partners, provide timely feedback to secure
prompt resolution of technical and quality findings. • Work effectively in cross-functional teams and support the team objectives in
delivering project milestones.
• Work closely with CMOs and CROs to ensure timely release of manufactured
drug substances and drug products.
• Draft or review pharmaceutical development reports, relevant sections of CMC
documentations in support of INDs, IMPDs and NDAs submissions.
• Responsible to use science driven and QbD and risk management-based
approach to develop robust API and drug product manufacturing processes.
• Responsible for API manufacturing and drug product manufacturing process
development, scale-up and the manufacturing to enable project advancement
from preclinical to clinical and from clinical to commercialization.
• Critically review data from contract partners, provide timely feedback to secure
prompt resolution of technical and quality findings.
• Work effectively in cross-functional teams and support the team objectives in
delivering project milestones.
• Work closely with CMOs and CROs to ensure timely release of manufactured
APIs and drug products.
• Author and review pharmaceutical development reports, relevant sections of
CMC documentations in support of INDs, IMPDs and NDAs submissions.   

• Establish SOPs and workflows and find creative ways to resolve problems.
• Compiles and reports pharmaceutical development status to study teams and
senior management.
• Assists in designing and continuously improving Quality Control systems,
processes and procedures.
• Assists with developing and validating testing methodology.