Assoc Director, API Process Science

Objectives

The Associate Director, MSAT Synthetic Molecule API is responsible for managing technical issues relating to the global external manufacturing of commercial Drug Substance. The focus is to provide technical leadership within MSAT Synthetic Molecule, Drug Substance group for the management of specialty small molecules relevant to key therapeutics drug substance.

The individual will be directly responsible for commercial manufacturing of drug substance, process design, optimization, scale-up, technology transfer, validation and maintaining the Life-Cycle Management (LCM) of the product. The individual will lead resolution of technical issues relating to a product line or major technical projects within MSAT Synthetic Molecule, and lead a small group (internal and external) of Technical Operations staff to manage technical programs and contract manufacturing organizations (CDMOs).

Accountabilities

• Provide direct leadership for day-to-day technical activities for synthetic commercial drug substance manufacturing, including troubleshooting, process changes and improvements, new manufacturing technology implementation, process analytical tools, and statistical analysis using software such as JMP.
• Apply working knowledge of phase appropriate CMC development throughout drug development, including implementation of Process Performance Qualification (PPQ)/Validation and LCM activities, strategies, protocol development and implementation.
• 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 groups.
• Lead compilation and analysis of production data, such as IPC, release, DoE, and manufacturing process information, to improve quality and ROIs on projects.
• Lead discussions and presentations in multi-disciplinary meetings (QA, QC, CMC RA, Drug Product, compliance) of manufacturing data summaries to improve manufacturing efficiency.
• Apply knowledge and phase appropriate implementation strategies of QbD during life-cycle management of the product.
• Maintain knowledge and understanding of current ICH guidelines and related industry practices such as ISO.
• Author pertinent SOPs and manufacturing process instructions.
• Direct and provide technical leadership on Change Controls, investigations, and CAPAs, including writing justifications to close out investigations and CAPA implementation internally and externally.
• Lead critical technical projects relating to the manufacturing of commercial MSAT Synthetic Molecule drug substance.
• Author and review relevant dossier sections (Module 3) related to commercial manufacturing submissions and relevant process knowledge documentation.
• Identify and test strategies to reduce manufacturing risks and maintain product life-cycle management.
• Manage/supervise interns, contractors and FTEs as appropriate.

Scope of Supervision

Direct: Employees - 0. In-Direct: Non-Employees - 1-2.

Education, Behavioural Competencies and Skills

The candidate should have an MS in chemistry, chemical engineering, pharmaceutical engineering or other scientific discipline and 5-10 years of experience, or a PhD with 5+ years of experience working in commercial pharmaceutical/chemical industry for synthetic drug substance. The ideal candidate should have direct management experience with external Contract Manufacturing Organizations.

The candidate should have a good working knowledge of cGMP manufacturing operations, and/or drug substance manufacturing with experience with small molecules, preferred. The preferred candidate will also have a background in QA or other industry relevant background. The candidate needs working knowledge of CMC regulations, cGMP, and ICH guidelines. The candidate should have working knowledge of process qualification for Accelerated and Breakthrough designation programs. The candidate should have advanced knowledge of Excel as well as other Microsoft Office suite software. Other analytical software usage such as JMP or MATLAB is also preferred. The candidate should have working knowledge and understanding of DoE and QbD. The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment.

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.