TAKEDA PHARMACEUTICALS AMERICA, INC.
Associate Director-Process Engineer SM API Process Sci
TAKEDA PHARMACEUTICALS AMERICA, INC., Boston, Massachusetts, us, 02298
Overview
Title: Associate Director-Process Engineer SM API Process Sci Location: Cambridge, MA (Hybrid) Job Description: 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.
Responsibilities
Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization; may serve as Takeda’s expert on small molecule API process and technologies.
Provides leadership for 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 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 efforts 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 systems to share expertise across global Takeda products and sites.
Collaborates with other functions within GMS such as API in Onco&ES SM OpU, Network strategy in Strategy & Business Excellence, etc.
Manages Manufacturing Operating Unit Site leads and Local Technical Services functions as applicable.
Leadership
Provide vision and strategy for manufacturing technology projects.
Lead and influence the local MSci organization for global manufacturing strategy alignment.
Effectively communicate Global Manufacturing Sciences visions across the functions.
Understand API manufacturing from phase-appropriate development to commercial scale.
Have a solid understanding of Organic Chemistry/Pharmaceutical chemistry.
Work within a multi-functional team (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC, etc.).
Utilize root cause analysis to investigate process and equipment issues and implement corrective and preventive actions in a cross-functional team.
Provide SME support for Due Diligence of M&A and other in-licensing activities.
Lead or 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.
Self-motivated with good interpersonal skills; able to analyze and solve complex problems through innovative thought and experience.
Strategic enterprise thinking with a patient-centered approach.
Ability to create an environment that inspires and enables people.
Ability to focus on priorities and deliver superior results.
Potential to elevate capabilities for now and the future.
Compensation and Benefits U.S. Base Salary Range: $153,600.00 - $241,340.00 per year. The estimated salary range reflects an anticipated range for this position; actual base salary offered depends on qualifications, experience, skills, location, and other factors.
Location: Boston, MA (as applicable in compensation notice). U.S. employees may be eligible for short-term and/or long-term incentives, and a comprehensive benefits package including health, 401(k) and other standard offerings.
Equal Employment Opportunity Takeda is proud to be an equal opportunity employer. We are committed to creating a diverse workforce and providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected veteran status in accordance with applicable laws.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Business Development and Sales
Industries: Pharmaceutical Manufacturing
Locations: Boston, MA
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Title: Associate Director-Process Engineer SM API Process Sci Location: Cambridge, MA (Hybrid) Job Description: 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.
Responsibilities
Leads the GMSci, Global Process Science, Small Molecules API Manufacturing Science organization; may serve as Takeda’s expert on small molecule API process and technologies.
Provides leadership for 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 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 efforts 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 systems to share expertise across global Takeda products and sites.
Collaborates with other functions within GMS such as API in Onco&ES SM OpU, Network strategy in Strategy & Business Excellence, etc.
Manages Manufacturing Operating Unit Site leads and Local Technical Services functions as applicable.
Leadership
Provide vision and strategy for manufacturing technology projects.
Lead and influence the local MSci organization for global manufacturing strategy alignment.
Effectively communicate Global Manufacturing Sciences visions across the functions.
Understand API manufacturing from phase-appropriate development to commercial scale.
Have a solid understanding of Organic Chemistry/Pharmaceutical chemistry.
Work within a multi-functional team (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC, etc.).
Utilize root cause analysis to investigate process and equipment issues and implement corrective and preventive actions in a cross-functional team.
Provide SME support for Due Diligence of M&A and other in-licensing activities.
Lead or 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.
Self-motivated with good interpersonal skills; able to analyze and solve complex problems through innovative thought and experience.
Strategic enterprise thinking with a patient-centered approach.
Ability to create an environment that inspires and enables people.
Ability to focus on priorities and deliver superior results.
Potential to elevate capabilities for now and the future.
Compensation and Benefits U.S. Base Salary Range: $153,600.00 - $241,340.00 per year. The estimated salary range reflects an anticipated range for this position; actual base salary offered depends on qualifications, experience, skills, location, and other factors.
Location: Boston, MA (as applicable in compensation notice). U.S. employees may be eligible for short-term and/or long-term incentives, and a comprehensive benefits package including health, 401(k) and other standard offerings.
Equal Employment Opportunity Takeda is proud to be an equal opportunity employer. We are committed to creating a diverse workforce and providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected veteran status in accordance with applicable laws.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Business Development and Sales
Industries: Pharmaceutical Manufacturing
Locations: Boston, MA
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