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Job Description

Title: Associate Director-Process Engineer SM API Process Sci

Location: Cambridge, MA (Hybrid)

About the role:

As an Associate Director-Process Engineer SM API Process Sci, you will provide process engineering support in batch or continuous API platforms through application of chemical engineering and process chemistry fundamentals from clinical to commercial stage. You will also Integrate mechanistic modelling, process simulation, and analysis into current and future processes (as part of product Life-Cycle Management) to enhance process understanding and controls. You will Identify and implement continuous improvement opportunities related to equipment and processes as a core member of a cross-functional process team and provide support to marketing applications for Global markets as well as play a key role in responding to RtQs from Global Health Authorities.

How will you contribute:

• Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization ; may serves as Takeda’s expert on small molecule API process and technologies.

• Provides strong leadership for the following activities, along with Pharmaceutical Sciences and/or Operation Units: API Manufacturing Process Characterization, Technology Transfer from/to external CMOs and/or internal manufacturing sites. Process validation, Risk assessment, Global expansion, COGs management, Regulatory Activities, Process / Product knowledge.

• Leads projects within Takeda product portfolio, both development and commercial, to support Small Molecules API Manufacturing Sciences activities.

• Develops and implements strategies for the continuous improvement on the manufacturing of Marketed Products in the late phase of the product life cycle.

• Leads the team to implement the manufacturing strategy for key Takeda products at internal manufacturing network and external CMOs.

• Leads the effort to create systems and procedures for best practice in commercial technology transfer, process validation.

• Leads the team that serves as the central hub of manufacturing process knowledge and establishes system and procedures to ensure the expertise and process knowledge are shared across global Takeda products and sites.

• Accountable for successful collaboration with 

• Other functions within GMS such as API in Onco&ES SM OpU, Network strategy in Strategy & Business Excellence etc.

• o    Manufacturing Operating Unit Site leads.

• o    Local Technical Services functions.

• o    Pharmaceutical Sciences counterparts.

• o    Other key functional groups such as Global Quality, Regulatory CMC etc.

Leadership

• Provide vision and strategy for manufacturing technology projects

• Ability to lead and influence the local MSci organization for global manufacturing strategy alignment.

• Effectively communicate Global Manufacturing Sciences visions across the functions.

• Understanding of API manufacturing from phase appropriate development stage to commercial scale.

• Must have sound understanding of Organic Chemistry/Pharmaceutical chemistry.

• Ability to work within a multi-functional team (i.e., Engineering, Manufacturing Operations, Manufacturing Sciences, CMC team etc.).

• Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions in a cross-functional team.

• Provide SME support for Due Diligence of M&A and other in-licensing activities.

• Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.

What you bring to Takeda:

• MS/PhD in Chemical or Process Engineering or Pharmaceutical Engineering.

• At least 5+ years’ experience in a cGMP environment.

• At least 5+ years of pharmaceutical industry experience in small molecules is preferred.

• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

• Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust.

• Creating the environment that inspires and enables people.

• Focusing on the few priorities and provide superior results.

• Elevating capabilities for now and the future.

#GMSGQ

#ZR1

#LI-MA1

#Hybrid

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$153,600.00 - $241,340.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.