Associate Director - MSAT Synthetic Molecule API

Takeda•Boston, MA

5d•€100,000 - €137,500

About The Position

The Associate Director, MSAT Synthetic Molecule API provides technical leadership for global external manufacturing of commercial drug substance, with a focus on specialty small molecules supporting key therapeutics. The role is directly responsible for commercial drug substance manufacturing, process design, optimization, scale-up, technology transfer, validation, and product life-cycle management. The position leads resolution of technical issues for product lines and major technical projects, and leads a small group of internal and external technical operations staff managing technical programs and contract manufacturing organizations (CDMOs). Technical leadership is provided with patient safety and business requirements as key considerations. The role oversees day-to-day technical activities, interfaces with third-party manufacturers and internal quality, CMC regulatory, compliance, and supply chain groups, and leads technical projects and manufacturing improvements. It also authors and reviews manufacturing instructions, SOPs, change controls, investigations, CAPAs, and relevant commercial manufacturing dossier sections.

Requirements

MS in chemistry, chemical engineering, pharmaceutical engineering, or another scientific discipline with 5–10 years of relevant experience, or a PhD with 5 or more years of relevant experience in the commercial pharmaceutical or chemical industry for synthetic drug substance.
Working knowledge of cGMP manufacturing operations and/or drug substance manufacturing.
Working knowledge of CMC regulations, cGMP, and ICH guidelines.
Working knowledge and understanding of DoE and QbD.
Demonstrated written and oral communication skills and ability to work in a cross-functional team environment.
Ability to travel to meetings or client sites, including overnight trips; some international travel may be required, with up to 5–20% domestic and international travel.

Nice To Haves

Direct management experience with external Contract Manufacturing Organizations.
Experience with small-molecule drug substance manufacturing.
Background in QA or another industry-relevant field.
Working knowledge of process qualification for Accelerated and Breakthrough designation programs.
Advanced knowledge of Excel and other Microsoft Office suite software.
Experience using analytical software such as JMP or MATLAB.

Responsibilities

Lead day-to-day technical activities for Takeda synthetic commercial drug substance manufacturing, including troubleshooting, process changes and improvements, new manufacturing technology implementation, process analytical tools, and statistical analysis.
Apply phase-appropriate CMC development knowledge, including development and implementation of PPQ/validation and life-cycle management strategies and protocols.
Serve as the primary technical interface between MSAT Synthetic Molecule, third-party drug substance manufacturers, and Takeda QA, QC, CMC regulatory, compliance, and supply chain groups.
Compile and analyze production data, including IPC, release, DoE, and manufacturing process information, to improve product quality and project returns.
Present manufacturing data summaries in multidisciplinary meetings to improve manufacturing efficiency.
Apply QbD strategies during product life-cycle management.
Author relevant SOPs and manufacturing process instructions.
Provide technical leadership on change controls, investigations, and CAPAs, including preparing justifications for investigation closure and CAPA implementation.
Lead critical technical projects related to manufacturing Takeda commercial MSAT Synthetic Molecule drug substance.
Author and review relevant Module 3 dossier sections for commercial manufacturing submissions and process knowledge documentation.
Identify and test strategies to reduce manufacturing risks and maintain product life-cycle management.
Manage or supervise interns, contractors, and FTEs as appropriate.