Manager, Process Science

Takeda; United States; Remote; USD 140,000 - 182,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Sick leave

Holidays

Incentive compensation

Job summary

Takeda Manufacturing USA, Inc. in Cambridge, MA, is seeking a Manager, Process Science to lead manufacturing technology and sciences for drug product manufacturing.

The role serves as SME for major technical transfer and validation projects and collaborates across sites and functions. As the global DP SME, you will drive regulatory interactions including CMC content, manage process characterization, tech transfer, and validation activities, and support continuous improvement with

Responsibilities

• Provide SME for manufacturing technology and sciences related to drug product manufacturing.
• Lead Drug Product Manufacturing Process Characterization, Technology Transfer, and process validation.
• Lead regulatory interactions including CMC content for dossiers.
• Collaborate across GMS Manufacturing Operating Unit and other key functions.

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.

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