Full Job Description
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.
REQUIREMENTS: 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.
Full time. $140,234 to $182,270 per year.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
