Process Scientist; Associate Director - Global Manufacturing Science GMSci DP​/PKG

Role Summary

Process Scientist (Associate Director) - Global Manufacturing Science GMSci Drug Product (DP). Provides technical expertise within the GMSci DP organization relating to manufacturing technology and sciences for multi-modal biologics, small molecule, and plasma DP manufacturing. Serves as the Subject Matter Expert for significant technical transfers and validation projects, leads regulatory interactions including preparing CMC content for dossiers, and ensures process knowledge is shared across sites as Takeda's global DP SME for resolving issues.

• Lead activities with Pharmaceutical Sciences and/or Operation Units, including technology transfer to CMOs and Takeda sites, DP manufacturing process validation, and rapid response teams.
• Manage projects within Takeda product portfolio (development and commercial) to support Manufacturing Sciences DP activities, including high impact life cycle management projects.
• Collaborate with Pharmaceutical Sciences, Manufacturing Sciences, Global Manufacturing Supply, Global Quality, and Global Regulatory Affairs; act as SME for Takeda drug product manufacturing organization and network.
• Demonstrate in-depth and broad understanding of DP manufacturing technologies for solid oral dosage forms and/or injectable products; apply industry best practices and emerging technologies; communicate and implement innovative DP technologies.
• Influence decisions of Pharmaceutical Sciences to ensure successful commercialization; independently make complex decisions impacting DP manufacturing organization.
• Partner with local Manufacturing Sciences to ensure consistent application of best technology practices across the Takeda network; share process knowledge across sites and functions; manage within a matrix of reporting lines across functional areas.
• Provide leadership to drive highly complex projects spanning multiple sites and products.

• BS or graduate degree in Chemistry, Chemical Engineering, or related discipline with 15+ years of industrial experience or equivalent.
• Minimum 10 years of experience in pharmaceutical development and/or manufacturing.
• Previous experience as an SME lead in a DP manufacturing matrix environment.
• Ability to prioritize and deliver superior results; ability to elevate business and personal capabilities as technologies change.
• Comfort with multi-modality complexity and ability to collaboratively solve problems with minimal initial process knowledge (e.g., rapid response situations or new technology evaluation and implementation).
• In depth and broad understanding of drug product manufacturing technologies for solid oral dosage form and/or injectable products; knowledge of best practices and emerging technologies for DP manufacturing.

• Technical expertise in manufacturing technology and sciences for DP; experience with technology transfer, validation, and regulatory interactions (CMC).
• Strong cross-functional collaboration and communication; ability to influence decisions across multiple sites and functions.
• Experience with rapid response and problem-solving in multi-modality DP manufacturing environments.

• BS or graduate degree in Chemistry, Chemical Engineering, or related discipline (as specified above).

• Location:
  
  Boston, MA (Hybrid work arrangement).