TAKEDA PHARMACEUTICALS AMERICA, INC.
CMC Lead, Small Molecules
TAKEDA PHARMACEUTICALS AMERICA, INC., Boston, Massachusetts, us, 02298
About the role
As a CMC Lead, Small Molecules (Associate Director), you will be responsible for leading and managing the engineering operations within the organization. You will focus on ensuring standards of quality, cost, safety, reliability, and performance are met in production processes. You will develop and implement new products, processes, and standards, this role supports Takeda's mission to bring better health to people and a brighter future to the world. How You Will Contribute
Provide strong direction to CMC Leads to drive effective life cycle management for Takeda’s commercial small molecule portfolio. Provide strong leadership for initiatives which are complex or span across multiple products. Lead a small team within GMSci small molecule to work across other GMSci organizations, internal and external manufacturing sites, and Pharmaceutical Sciences to define directions for technology excellence and innovation including digital solutions and data analytics. Drive effective communication for group activities across the organization including leading regular reviews of product and method performance, continuous improvement plans, and experimental approaches, to lead global process-related change controls or initiatives and to perform the global reporting of process performance. Lead multiple CMC teams with competing priorities. Able to determine priorities within Takeda’s portfolio with ambiguity without full information. Able to work through uncertainty and lead the team to a resolution in decision. Has a deep and broad understanding of small molecule manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen. Leadership
An enterprise manager balancing and aligning goals and priorities to meet company objectives. Ability to influence broadly within the organization to drive decisions, alignment, and conflict resolution for complex cross-functional CMC and technology excellence issues. Work closely with the associated PMs for each program to drive to the success of the CMC team. Being a mentor developing future leaders. Provides vision and passion for driving technology and innovation within the small molecule portfolio. Able to operate effectively through ambiguity. Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization. Decision-making and Autonomy
Full accountability for complex decisions regarding allocation of resources within the CMC and Technology Excellence group for effective management of these activities across the product portfolio. Interaction
Works across GMSci small molecule organization (including API and DP) to align CMC LCM activities within the various GMSci functional organizations. Works across GMSci global functions as needed for business metrics and align on LCM procedures. Works across GMSci small molecule (API and DP), Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for LCM and Technology Excellence. Works with the GMSci LCM group on coordination of hand-off of late stage products to the commercial team. Innovation
Scope includes innovation in manufacturing equipment, manufacturing processes, and use of digital technology to provide data-driven approaches. Complexity
Manages with a matrix of reporting lines and across functional area. Provides leadership to drive highly complex projects involving crossing across multiple sites and products. What You Bring To Takeda
Bachelor degree in engineering or life sciences. Minimum 8 – 15 years of experience in pharmaceutical development and manufacturing. Experience operating globally in a matrixed organization highly preferred. Experience defining the strategy and roadmap for complex, cross-functional initiatives. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as project management tools. 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. 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. 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
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As a CMC Lead, Small Molecules (Associate Director), you will be responsible for leading and managing the engineering operations within the organization. You will focus on ensuring standards of quality, cost, safety, reliability, and performance are met in production processes. You will develop and implement new products, processes, and standards, this role supports Takeda's mission to bring better health to people and a brighter future to the world. How You Will Contribute
Provide strong direction to CMC Leads to drive effective life cycle management for Takeda’s commercial small molecule portfolio. Provide strong leadership for initiatives which are complex or span across multiple products. Lead a small team within GMSci small molecule to work across other GMSci organizations, internal and external manufacturing sites, and Pharmaceutical Sciences to define directions for technology excellence and innovation including digital solutions and data analytics. Drive effective communication for group activities across the organization including leading regular reviews of product and method performance, continuous improvement plans, and experimental approaches, to lead global process-related change controls or initiatives and to perform the global reporting of process performance. Lead multiple CMC teams with competing priorities. Able to determine priorities within Takeda’s portfolio with ambiguity without full information. Able to work through uncertainty and lead the team to a resolution in decision. Has a deep and broad understanding of small molecule manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen. Leadership
An enterprise manager balancing and aligning goals and priorities to meet company objectives. Ability to influence broadly within the organization to drive decisions, alignment, and conflict resolution for complex cross-functional CMC and technology excellence issues. Work closely with the associated PMs for each program to drive to the success of the CMC team. Being a mentor developing future leaders. Provides vision and passion for driving technology and innovation within the small molecule portfolio. Able to operate effectively through ambiguity. Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization. Decision-making and Autonomy
Full accountability for complex decisions regarding allocation of resources within the CMC and Technology Excellence group for effective management of these activities across the product portfolio. Interaction
Works across GMSci small molecule organization (including API and DP) to align CMC LCM activities within the various GMSci functional organizations. Works across GMSci global functions as needed for business metrics and align on LCM procedures. Works across GMSci small molecule (API and DP), Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for LCM and Technology Excellence. Works with the GMSci LCM group on coordination of hand-off of late stage products to the commercial team. Innovation
Scope includes innovation in manufacturing equipment, manufacturing processes, and use of digital technology to provide data-driven approaches. Complexity
Manages with a matrix of reporting lines and across functional area. Provides leadership to drive highly complex projects involving crossing across multiple sites and products. What You Bring To Takeda
Bachelor degree in engineering or life sciences. Minimum 8 – 15 years of experience in pharmaceutical development and manufacturing. Experience operating globally in a matrixed organization highly preferred. Experience defining the strategy and roadmap for complex, cross-functional initiatives. Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as project management tools. 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. 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. 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
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