Associate Director, Oral Drug Product Development (ODPD)

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Job Description

Objective:

Under the direction of the Director or Sr. Director, ODPD, the Assoc. Director is responsible for supporting the Takeda pipeline programs with expertise in drug product formulation development, process development, drug product manufacturing, regulatory support, validation thru commercialization of oral drug products for global markets. Expertise in drug product manufacturing process optimization, scale up and QbD are required. The Assoc. Director actively manages and oversees Takeda employees and contractors to achieve Takeda pipeline project and ODPD function goals. The individual sets and defines drug product goals upon project inception and implements actions required in achieving program goals. The individual is expected to represent the Department on PSTs/GPTs, and other cross functional forums as deemed necessary.

Job Description:

• Develops CMC strategy for the oral drug products and provide budget estimates for R&D pipeline projects.

• Manages the development of drug product formulation/manufacturing processes at both internal laboratories and at external CDMOs

• Responsible for providing guidance to Takeda contractors as needed

• Writes/reviews/approves protocols and reports for drug products

• Manages any reporting staff (Takeda employees and/or contractors).

• Prepares or supervises preparation of high-quality DP-CMC sections for Global regulatory filings to meet accelerated submission timelines and manages RTQs in a timely manner 

• Actively participates in preparations for internal audits and regulatory inspections and agency interactions.

• Is an active member of Pharm Sci teams.

• Contributes to ODPD/DPDD/PharmSci innovation/improvement initiatives.

• Performs CMC due diligence evaluations of potential new or in-licensed products on behalf of Pharmaceutical Sciences.

• Uses In-Silico, DOE and QbD principles in developing Drug Product manufacturing processes.

• Interacts with counterparts in GMSGQ to ensure robust processes are effectively transferred to both internal and external sites.

• Prepares and<