Manager, Process Science

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.

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.

Boston, MA

Employee

Regular

Full time