Associate Director - MSAT Synthetic Molecule API

Associate Director - MSAT Synthetic Molecule API

Function: MSAT Synthetic Molecules - Department: GSQ - MSAT Synthetic Molecules.

Accountabilities

• Provide direct leadership for day-to-day technical activities for Takeda's synthetic commercial drug substance manufacturing - i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation, process analytical tools, statistical analysis using software such as JMP etc.
• Must have working knowledge of phase appropriate CMC development throughout the drug development which includes understanding and implementation of "Process Performance Qualification (PPQ)/Validation", LCM activities etc. strategies and protocol development and implementations.
• Lead and act as the primary interface on technical issues between MSAT Synthetic Molecule and third-party drug substance manufacturers and with Takeda's quality (QA and QC), CMC regulatory, compliance, and supply chain group.
• Lead the exercise in the compilation and analysis of production data, such as IPC, release, DoE, and manufacturing process information relating to Takeda's synthetic molecule product portfolio to improve the quality and ROIs on the projects.
• Lead discussions on the presentation in multi-disciplinary meetings (QA, QC, CMC RA, Drug Product, compliance) of manufacturing data summary to improve manufacturing efficiency.
• Must have the knowledge and phase appropriate implementation strategies of QbD during Life-cycle management of the product.
• Must have knowledge and understanding of current ICH guidelines and related industry practices such as ISO etc.
• Author pertinent SOP's and manufacturing process instructions.
• Direct and provide technical leadership on Change Controls, investigations, and CAPAs.
• Lead critical technical projects relating to the manufacturing of Takeda commercial MSAT Synthetic Molecule drug substance.
• Author and review relevant dossier sections (Module 3) related to commercial manufacturing submissions and relevant process knowledge documentations.
• Identify, and test, strategies to reduce manufacturing risks and maintain the product Life-cycle management.
• Manage/Supervise interns, contractors and FTE's, as appropriate.

Scope of Supervision

• Direct: Employees - 0; Non-employee - 0
• In-Direct: Employees - 1 to 2; Non-employee - 0

Education, Behavioural Competencies and Skills

• MS in chemistry, chemical engineering, pharmaceutical engineering or other scientific discipline and 5-10 years of experience or PhD with 5+ year's experience working in commercial pharmaceutical/chemical industry for synthetic drug substance.
• Ideal candidate should have had direct management experience with external Contract Manufacturing Organizations.
• Good working knowledge of cGMP manufacturing operations, and/or drug substance manufacturing with experience with small molecules, preferred.
• Background in QA or other industry relevant background.
• Working knowledge of CMC regulations, cGMP, and ICH guidance lines.
• Working knowledge of process qualification for "Accelerated" and "Breakthrough designation" programs.
• Advanced knowledge of Excel as well as other Microsoft Office suite software.
• Other analytical software usage such as JMP or MATLAB is also preferred.
• Working knowledge and understanding of DoE and QbD etc.
• Demonstrated written and oral communication skills and ability to work in a cross functional team environment.

Licenses / Certifications

N/A

Physical Demands

Office work Computer use Airline travel

Travel Requirements

Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Position requires up to 5-20% domestic and international travel.

Locations

Bray, IrelandBoston, MA

Salary

Base Salary Range: €100,000.00 - €137,500.00

Worker Type

Employee - Regular Time - Full time

Company Culture

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people's lives - including your own.

Equal Opportunity Statement

Takeda is an equal opportunity employer.

For applicants of U.S and Puerto Rico positions:

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