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Job Description

About the role:

As a Principal Scientist, you will be the primary technical point of contact for the API MST with external Contract Manufacturing Organizations (CMOs). You will provide scientific and technical expertise for all drug substance-related activities, ensuring that new and existing drug substance technology and related processes, procedures and specifications are transferred to our CMOs in a manner compliant with all regulatory and quality standards and to support cost-effective technical processes suitable for robust commercial production.

How you will contribute:

• Process Design, Development and Optimization.

• Technology Transfer.

• Process Validation and CPV.

• Continuous improvement.

• Change Management.

• Technical support and oversight of commercial API manufacturing.

• Partner with Pharmaceutical Sciences (PS) and Global Manufacturing Sciences (GMSci) in late-stage process development with technology selection, process design and optimization.

• Design, develop and optimize API manufacturing processes using robust DoE and QbD principles.

• Implement right first time (RFT) Technology Transfers and manage commercial API manufacturing to meet business needs ensuring timing, quantity, quality, costs and regulatory requirements.

• Define and implement process, equipment and scale related critical process parameters.  Assess the risk levels for scale up and equipment changes to enable supply chain flexibility.

• Author, review and approve relevant technical documentation, protocols, reports and regulatory submissions including Process risk and safety Assessment, Technology transfer plan, Validation master plan etc.

• Assure CMOs can pass regulatory inspections by the FDA and other government regulatory agencies.  Support regulatory inspections and audits. 

• Author and review regulatory documents for technical consistency and compliance for NDA and DMF. Provide responses to technical queries from the agencies.

• Lead, prioritize and drive deviation investigations and RCAs using standardized approaches. Ensure the necessary CAPAs are implemented at the CMOs.  Raise and manage change controls.

• Develop and maintain technical product knowledge database and technical documents for assigned APIs.  Dissect and interpret data from various sources, using the information to create scientific reports. 

• Stay abreast of the relevant cGMP, ICH and global Regulatory CMC guidance documents.

• Communicate successfully to present complex scientific information and develop credible relationships with a broad spectrum of people, including CMO’s and Colleagues.

• Interact internally in person or remotely with individuals from Product Strategy, Quality, Compliance, External Supply Management, PS, GMSci, Regulatory Affairs and SMO OpU.

• Interact externally in person or remotely with key Suppliers and CMOs.

What you bring to Takeda:

• PhD in Organic Chemistry or Chemical Engineering with 8+ years or MS with 12+ years or BS with 16 years industrial experience.

• Hands-on experience in API process development, scale up, optimization and validation. 

• Direct experience in technology transfer and in supporting API manufacturing. Proven record for commercial process problem solving. 

• Strong knowledge of synthetic organic chemistry and modern analytical methods.

• Knowledge of QbD, DoE, PAT and risk assessment.

• Strong knowledge of cGMP/GLP regulations, ICH and FDA CMC Guidance Documents.  Knowledge of DEA Regulations is preferred.

• Up to 20% domestic and international travel required.

Desired

• Project Management Experience.

• Six Sigma Certification.

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