No more applications are being accepted for this job

Analytical Chemistry Scientist

1 month ago

Taipei, Taiwan Fyte Full time

Responsibilities

Develop analytical methods to support the drug substance and drug product analysis
Perform R&D sample analysis
Generate and interpret structure elucidation of drug substance and impurities
Perform analytical testing to support trouble shooting or investigation of CMC issues as needed
Support the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for projects.
Lead the analytical review of programs at project team meetings with support from subject matter experts.
Perform data entry, data review, and author analytical reports or data summaries.
Lead the troubleshooting and investigation of any issues associated with the DS/DP analytical testing through active collaboration with CROs, CMOs and subject matter experts.
Support compliance audit/inspection activities.

Requirement:

A minimum of a MS degree in Analytical Chemistry or a related scientific discipline with at least 7 years of experience in pharmaceutical development is required. A Ph.D. in Analytical Chemistry or a related scientific discipline with at least 3 years of experience in pharmaceutical development is preferred.
Experience on cross-functional teams and CROs/CMOs interactions with the ability to lead and execute study plans/deliverables is preferred.
Lab experience in chromatographic separations, formulation analysis (ocular and injectable dosage forms) and characterization of DS/DP quality methods
Working knowledge in regulatory guidance for pharmaceutical development is required.
Experience in preparing and reviewing CMC sections of clinical trial applications (INDs/IMPDs) and addressing health authority questions is preferred.
Strong leadership, communication (oral and written), negotiation skills and ability of collaboration across teams in a matrix environment are required.

Manufacturing Process Engineer