[Hiring] Manager, Process Science @Takeda

Role Description

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science with the following duties:

• Provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing.
• Serve as the Subject Matter Expert (SME) for leading major technical transfer or validation projects relating to new product introduction or life cycle management of existing products.
• Provide leadership for regulatory interactions including CMC content for dossiers.
• Ensure process knowledge is shared and leveraged across sites and functions.
• Serve as Takeda’s global DP SME for issue resolution as needed.
• Act as Takeda’s expert on small molecule OSD or parenterals process and technologies.
• Lead activities such as Drug Product Manufacturing Process Characterization, Technology Transfer, and process validation.
• Serve as part of rapid response teams for local manufacturing Operating Units.
• Manage projects within Takeda’s product portfolio to support Manufacturing Sciences DP and Packaging Science activities.
• Develop and implement strategies for continuous improvement of marketed products.
• Ensure successful collaboration with various functions within the GMS Manufacturing Operating Unit and other key functional groups.

Up to 5% domestic and international travel required to manufacturing and partner sites to oversee technology transfer, scale-up initiatives, process validation (PPQ), and to resolve technical issues that directly impact global product supply and regulatory compliance. Up to 65% remote work allowed.

Qualifications

• Master’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field plus 8 years of related experience, OR
• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field plus 10 years of related experience.

Requirements

• Prior experience must include:
• Design and execute formulation and process development strategies, including experimental design, parameter selection, and scale-up considerations across pharmaceutical dosage forms.
• Analyze process, analytical, dissolution, & stability data to evaluate process performance, identify variability trends.
• Develop technical documentation, including development reports, protocols, batch records, and regulatory documents to support manufacturing and regulatory requirements.
• Translate process parameters across equipment & manufacturing sites & develop comparability approaches for scale-up and technology transfer activities.
• Execute process validation & lifecycle management activities, including process validation planning, stability strategy development, & continuous process improvement initiatives.
• Execute and monitor sterile manufacturing process activities, including aseptic operations, sterility assurance controls, filtration processes, environmental monitoring, & container closure integrity evaluations.

Benefits

• Estimated salary range: $140,234 to $182,270 per year.
• Medical, dental, & vision insurance.
• 401(k).
• Paid time off.
• Sick leave.
• Company holidays.
• Incentive compensation programs.
• Other benefits offered under company policies.

Company Description

Qualified applicants can apply at https://jobs.takeda.com . Please reference job #R0193457. EOE