Job Detail

CMC Lead, Manufacturing Sciences

Inseriert am: 23.02.2021

CMC Lead, Manufacturing Sciences


Zurich, Switzerland

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  • Overview

  • Success

  • Life at Takeda

  • Opportunity

  • Responsibilities

  • Map


Overview


Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.


Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.


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Success


What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.



  • Agile

  • Ambitious

  • Analytical

  • Collaborative

  • Enthusiastic

  • Entrepreneurial


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Life at Takeda



  • A Global Top Employer

    Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2021.


  • At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.

    Global Manufacturing

    Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.


  • About Takeda

    At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.



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Opportunity



  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.


  • Inclusive

    Here, you will feel welcomed, respected, and valued as a vital contributor our global team.


  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.


  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.


  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.


  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.



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CMC Lead, Manufacturing Sciences

Apply NowJob ID R0029184Date posted 03.16.2021Location Zurich, Switzerland

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.


Job Description


ACCOUNTABILITIES


The CMC lead is expected to work across GMSci Bio, other GMSci groups, sites, and Pharmaceutical Development to define directions for technology excellence and innovation including digital solutions and data analytics. This individual 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. The CMC lead is providing technical leadership to cross-functional forums. This individual will set the needed strategy to enable execution of Chemistry, Manufacturing, and Controls (CMC) activities throughout a product's lifecycle. This individual will lead or contribute as a key member of various cross-functional teams focused upon product development and commercial product support. This individual will interact extensively with other departments, including process and formulation development, analytical development, commercial manufacturing, QA, QC, engineering, supply chain, validation, tech transfer, and regulatory functions. 


The responsibilities will include:



  • Support the delivery of  product and maintain continuous supply of commercial product

  • Define and implement plans / roadmaps for lifecycle initiatives for products

  • Execute CMC strategy and submission plans to support regulatory filings for product launch and to enable market expansion

  • Implement plans to achieve post-marketing and regulatory commitments

  • Support the enhancement  of product and process knowledge and define and address process gaps through application of QbD best practices

  • Provide adequate SME support of major process and methods investigations.


DIMENSIONS AND ASPECTS


Technical/Functional (Line) Expertise



  • Has a deep and broad understanding of biologics manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen


Leadership



  • An experienced technical leader 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 LCM activities, or CMC and technology excellence issues

  • Being a mentor developing future CMC Leads and local or global SMEs

  • Provides vision and passion for driving technology and innovation for the products under his/her responsibility

  • 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 the LCM strategy, CMC priorities and Technology Excellence for the products under his/her responsibility


Interaction



  • Works across GMSci Bio to align CMC strategy and LCM activities with the Head of Biologics CMC, Head of Process Sciences and the Head of Biologics Product Sciences

  • Works across GMSci global functions as needed for business metrics and align on product governance and LCM procedures as well as submission process improvements

  • Works across GMSci Bio, Pharmaceutical Sciences, Site Manufacturing Sciences, GMSci Q and Regulatory CMC groups to align on vision and priorities for the products CMC strategy, LCM, Regulatory Submission and Technology Excellence priorities

  • Works with the Pharmaceutical LCM group on coordination of hand-off of late stage products to the commercial team


Innovation



  • Is a focal point for innovation within GMSci Bio to drive COGs reduction and stability in product supply

  • 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 areas

  • Provides leadership to drive highly complex projects involving across multiple sites and products


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


Education / experience



  • Advanced degree in engineering or life sciences; minimum MS, preferred PhD

  • Minimum 10 years 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


Skills



  • 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.


Behaviors



  • 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


Locations

Lexington, MAZurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0029184Apply NowEmail Me

Back to Job Navigation (Responsibilities)


CMC Lead, Manufacturing Sciences

Apply NowJob ID R0029184Date posted 03.16.2021Location Zurich, Switzerland

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.


Job Description


ACCOUNTABILITIES


The CMC lead is expected to work across GMSci Bio, other GMSci groups, sites, and Pharmaceutical Development to define directions for technology excellence and innovation including digital solutions and data analytics. This individual 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. The CMC lead is providing technical leadership to cross-functional forums. This individual will set the needed strategy to enable execution of Chemistry, Manufacturing, and Controls (CMC) activities throughout a product's lifecycle. This individual will lead or contribute as a key member of various cross-functional teams focused upon product development and commercial product support. This individual will interact extensively with other departments, including process and formulation development, analytical development, commercial manufacturing, QA, QC, engineering, supply chain, validation, tech transfer, and regulatory functions. 


The responsibilities will include:



  • Support the delivery of  product and maintain continuous supply of commercial product

  • Define and implement plans / roadmaps for lifecycle initiatives for products

  • Execute CMC strategy and submission plans to support regulatory filings for product launch and to enable market expansion

  • Implement plans to achieve post-marketing and regulatory commitments

  • Support the enhancement  of product and process knowledge and define and address process gaps through application of QbD best practices

  • Provide adequate SME support of major process and methods investigations.


DIMENSIONS AND ASPECTS


Technical/Functional (Line) Expertise



  • Has a deep and broad understanding of biologics manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen


Leadership



  • An experienced technical leader 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 LCM activities, or CMC and technology excellence issues

  • Being a mentor developing future CMC Leads and local or global SMEs

  • Provides vision and passion for driving technology and innovation for the products under his/her responsibility

  • 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 the LCM strategy, CMC priorities and Technology Excellence for the products under his/her responsibility


Interaction



  • Works across GMSci Bio to align CMC strategy and LCM activities with the Head of Biologics CMC, Head of Process Sciences and the Head of Biologics Product Sciences

  • Works across GMSci global functions as needed for business metrics and align on product governance and LCM procedures as well as submission process improvements

  • Works across GMSci Bio, Pharmaceutical Sciences, Site Manufacturing Sciences, GMSci Q and Regulatory CMC groups to align on vision and priorities for the products CMC strategy, LCM, Regulatory Submission and Technology Excellence priorities

  • Works with the Pharmaceutical LCM group on coordination of hand-off of late stage products to the commercial team


Innovation



  • Is a focal point for innovation within GMSci Bio to drive COGs reduction and stability in product supply

  • 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 areas

  • Provides leadership to drive highly complex projects involving across multiple sites and products


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


Education / experience



  • Advanced degree in engineering or life sciences; minimum MS, preferred PhD

  • Minimum 10 years 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


Skills



  • 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.


Behaviors



  • 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


Locations

Lexington, MAZurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0029184Apply NowEmail Me

Details