Manager, Process Science

Takeda Pharmaceutical Company Limited; Boston (MA); Hybrid; USD 140,000 - 182,000; Full time

Job summary

Takeda Manufacturing USA, Inc. is seeking a Manager, Process Science to lead technical transfer, process development, and lifecycle management for drug product manufacturing.

You will drive characterization, validation, and continuous improvement while coordinating cross-site activities and regulatory interactions. Qualified candidates hold an advanced degree with 8+ years of related experience, including design of development strategies, scale-up, and regulatory documentation.

Qualifications

• Advanced degree and 8+ years in formulation/process development or equivalent.
• Experience leading technology transfer, scale-up and process validation.
• Regulatory documentation support including CMC dossiers.

Responsibilities

• Lead major technical transfer or validation projects for new product introductions or lifecycle management.
• Provide SME support for manufacturing sciences DP and packaging science.
• Drive process characterization, transfer, validation, and continuous improvement across sites.

Skills

Process science expertise

Technology transfer

Scale-up

Process validation

Regulatory interactions

Education

Master's degree in Pharmaceutical Science/C Chemistry/Chemical Engineering

Bachelor's degree in Pharmaceutical Science/Chemistry/Chemical Engineering

Tools

CMC content for dossiers

Job description

Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Manufacturing USA, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Manager, Process Science

POSITION 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.

Estimated salary range reflects expected pay for this role. Actual base salary depends on the applicant's qualifications, experience, skills, education, certifications, & work location, & will comply with all applicable minimum-wage laws. U.S. employees may be eligible for medical, dental, & vision insurance, 401(k), paid time off, sick leave, company holidays, incentive compensation programs, & other benefits offered under company policies.

Full time. $140,234 to $182,270 per year.

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. 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.

EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time