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Position Summary:Execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and Takeda SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP). Leadership of the cross functional Study ...
POSITION SUMMARY: The successful candidate will be part of the Purification Process Development Department and will be involved in the development of purification processes for antibodies and the generation of antibody-drug-conjugates. DUTIES & RESPONSIBILITIES:• Development and optimization of purification processes for antibodies• Development and optimization of conjugation processes of antibody-drug ...
Position Summary:•Manage Small Molecules/Oral Solid Dosage analytical test methods validations and transfers for release and stability testing of commercial pharmaceutical products.•Manage complex scientific knowledge of analytical methods and updates•Manage a staff of qualified scientific employees and provide guidance in the area of expertise.Duties and Responsibilities:•Method design (re-design) and validation (re-validation) ...