Manager, Process Science

Takeda•Boston, MA

9d•Hybrid

About The Position

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science to provide technical expertise within the GMSci DP/Pkg organizations in manufacturing technology and sciences for drug product manufacturing. The role serves as a subject matter expert for major technical transfer and validation projects related to new product introduction and lifecycle management of existing products, and provides leadership for regulatory interactions, including CMC dossier content. The Manager helps share and leverage process knowledge across sites and functions, serves as Takeda’s global drug product subject matter expert for issue resolution as needed, and acts as an expert on small-molecule oral solid dosage or parenteral processes and technologies. The role leads drug product manufacturing process characterization, technology transfer, and process validation; participates in rapid-response teams for local manufacturing Operating Units; and manages projects supporting Manufacturing Sciences DP and Packaging Science activities. The position also develops and implements continuous-improvement strategies for marketed products and collaborates with functions across the GMS Manufacturing Operating Unit and other key groups. Up to 5% domestic and international travel is required to manufacturing and partner sites for technology transfer, scale-up, process validation, and technical issue resolution. Up to 65% remote work is allowed.

Requirements

Master’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field and 8 years of related experience, or a bachelor’s degree in one of these fields or a related field and 10 years of related experience.
Experience designing and executing formulation and process development strategies, including experimental design, parameter selection, and scale-up considerations across pharmaceutical dosage forms.
Experience analyzing process, analytical, dissolution, and stability data to evaluate process performance and identify variability trends.
Experience developing technical documentation, including development reports, protocols, batch records, and regulatory documents, to support manufacturing and regulatory requirements.
Experience translating process parameters across equipment and manufacturing sites and developing comparability approaches for scale-up and technology transfer.
Experience executing process validation and lifecycle management activities, including process validation planning, stability strategy development, and continuous process improvement initiatives.
Experience executing and monitoring sterile manufacturing process activities, including aseptic operations, sterility assurance controls, filtration processes, environmental monitoring, and container closure integrity evaluations.

Responsibilities

Provide technical expertise in manufacturing technology and sciences for drug product manufacturing within the GMSci DP/Pkg organizations.
Serve as the subject matter expert for major technical transfer or validation projects involving new product introduction or lifecycle management of existing products.
Lead regulatory interactions, including CMC content for dossiers.
Ensure process knowledge is shared and leveraged across sites and functions.
Serve as Takeda’s global drug product subject matter expert for issue resolution as needed.
Act as Takeda’s expert on small-molecule oral solid dosage or parenteral processes and technologies.
Lead drug product manufacturing process characterization, technology transfer, and process validation activities.
Serve on rapid-response teams for local manufacturing Operating Units.
Manage projects supporting Manufacturing Sciences DP and Packaging Science activities.
Develop and implement continuous-improvement strategies for marketed products.
Collaborate with functions within the GMS Manufacturing Operating Unit and other key functional groups.
Travel to manufacturing and partner sites to oversee technology transfer, scale-up initiatives, process validation (PPQ), and resolution of technical issues affecting global product supply and regulatory compliance.