Manager, Process Science

USA - 3383 Shire Human Genetic Therapies, Inc.; Cambridge (MA); Hybrid; USD 140,000 - 182,000; Full time

Benefits offered by this job

Remote work option

Medical, dental, vision insurance

401(k) with company match

Paid time off and holidays

Incentive compensation programs

Job summary

Takeda Manufacturing USA, Inc. in Cambridge, MA seeks a Manager, Process Science to lead technical transfer, process development, and lifecycle management for drug product manufacturing.

You will serve as SME for major projects, oversee scale-up, validation, and regulatory interactions, and drive continuous improvement across sites and functions. Domestic and international travel are involved, with up to 65% remote work allowed.

Qualifications

• Master’s or Bachelor’s degree in a related field with relevant pharma experience.
• 8–10 years of related experience in drug product development, tech transfer or lifecycle management.
• Experience designing and executing formulation and process development strategies.
• Ability to translate processes across equipment and sites and develop comparability approaches.
• Familiarity with regulatory documentation to support manufacturing and regulatory requirements.

Responsibilities

• Provide SME expertise for major tech transfer or validation projects.
• Lead Drug Product Manufacturing Process Characterization, Tech Transfer, and validation activities.
• Lead regulatory interactions including CMC content for dossiers.
• Ensure process knowledge sharing across sites and functions.
• Manage projects to support Manufacturing Sciences DP and Packaging Science.
• Develop and implement continuous improvement strategies for marketed products.
• Collaborate with GMS Manufacturing Operating Unit and other functional groups.

Skills

Process development

Scale-up

Process validation

Analytical data analysis

Documentation

Cross-site collaboration

Education

Master's degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field

Bachelor's degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field

Job description

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

• 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

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own.

Takeda is an equal opportunity employer.