BioSpace
Associate Director-Process Engineer SM API Process Sci
BioSpace, Boston, Massachusetts, us, 02298
Associate Director-Process Engineer SM API Process Sci
Location: Cambridge, MA (Hybrid) Base pay range
$153,600.00/yr - $241,340.00/yr 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 serve as Takeda’s expert on small molecule API process and technologies. Provides strong leadership for API Manufacturing Process Characterization, Technology Transfer from/to external CMOs and/or internal manufacturing sites. Includes process validation, risk assessment, global expansion, COGs management, regulatory activities, and 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 in 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 and process validation. Leads the team that serves as the central hub of manufacturing process knowledge and establishes systems to ensure 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. Manufacturing Operating Unit Site leads and Local Technical Services functions involvement; collaboration with Pharmaceutical Sciences and other key functional groups such as Global Quality and Regulatory CMC. 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 Sound understanding of Organic Chemistry/Pharmaceutical chemistry Work within a multi-functional team (e.g., Engineering, Manufacturing Operations, Manufacturing Sciences, CMC) Utilize root cause analysis to investigate process and equipment issues and deliver robust corrective and preventive actions Provide SME support for due diligence of M&A and other in-licensing activities Lead/support 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 (preferred) Self-motivated with good interpersonal skills; able to analyze and solve complex problems Strategic enterprise thinking and focus on delivering superior results Ability to create an environment that inspires and enables people Additional Information #GMSGQ #ZR1 #Hybrid EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or any other protected characteristic, consistent with applicable laws. Locations: Boston, MA Employment type: Full-time Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time
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Location: Cambridge, MA (Hybrid) Base pay range
$153,600.00/yr - $241,340.00/yr 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 serve as Takeda’s expert on small molecule API process and technologies. Provides strong leadership for API Manufacturing Process Characterization, Technology Transfer from/to external CMOs and/or internal manufacturing sites. Includes process validation, risk assessment, global expansion, COGs management, regulatory activities, and 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 in 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 and process validation. Leads the team that serves as the central hub of manufacturing process knowledge and establishes systems to ensure 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. Manufacturing Operating Unit Site leads and Local Technical Services functions involvement; collaboration with Pharmaceutical Sciences and other key functional groups such as Global Quality and Regulatory CMC. 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 Sound understanding of Organic Chemistry/Pharmaceutical chemistry Work within a multi-functional team (e.g., Engineering, Manufacturing Operations, Manufacturing Sciences, CMC) Utilize root cause analysis to investigate process and equipment issues and deliver robust corrective and preventive actions Provide SME support for due diligence of M&A and other in-licensing activities Lead/support 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 (preferred) Self-motivated with good interpersonal skills; able to analyze and solve complex problems Strategic enterprise thinking and focus on delivering superior results Ability to create an environment that inspires and enables people Additional Information #GMSGQ #ZR1 #Hybrid EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or any other protected characteristic, consistent with applicable laws. Locations: Boston, MA Employment type: Full-time Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time
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