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CMC Lead, Manufacturing Sciences
As a key member of the Biologics Global Manufacturing Sciences (GMSci) team, this individual will be responsible for providing technical and strategic leadership for the Chemistry, Manufacturing, and Controls (CMC) of one or several late stage or launched biopharmaceuticals. This individual will set the CMC life cycle management priorities and own the CMC roadmap for both Drug Substances and Drug Products, in tune with the strategic priorities of the Global Manufacturing & Supply (GMS) organization. The CMC Lead is expected to ensure that biopharmaceuticals manufacturing processes remain robust, performant, adherent to QbD principles, and aligned between manufacturing sites. The CMC Lead guarantees continuity and expansion of process knowledge throughout the product lifecycle, and is critical to drive the introduction of targeted innovation. As a technical and life cycle management expert of biopharmaceuticals, the CMC lead acts as a key partner for manufacturing, quality and regulatory functions. The CMC Lead provide broad technical oversight to product launch, post approval variations, technology transfers, regulatory interactions and troubleshooting. He/her will lead one or several CMC teams to drive the execution of CMC activities throughout the product's lifecycle. The CMC Lead represents the Global Manufacturing Sciences organization within several Global Product Teams focused on defining and executing biopharmaceuticals products manufacturing an supply strategies. This individual will interact extensively with other departments, including process and formulation development, analytical development, commercial manufacturing, QA, QC, engineering, supply chain, validation, technology transfer, and regulatory functions.
The responsibilities will include:
- Provide broad technical and strategic leadership for the Chemistry, Manufacturing, and Controls (CMC) life cycle management of one or several late stage or launched biopharmaceuticals
- Define and implement roadmaps for biopharmaceuticals CMC priorities and process improvements
- Guarantees process alignment and product comparability between multiple manufacturing sites
- Drives the execution of the CMC roadmap by leading CMC Teams
- Drive rigorous assessment of CMC issues, decisions and ensure appropriate approval/endorsement of technical recommendations.
- Represents the Global Manufacturing Sciences organization within several Global Product Teams
- Support regulatory filings for product launch, market expansion, 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
- Act as the Manufacturing Sciences and CMC expert during audits and interactions with regulatory agencies.
- Provide adequate SME support of major process and methods investigations.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
·Has a deep and broad technical expertise of biologics Drug Substance and Drug Product development and manufacturing. Understand the manufacturing, quality and regulatory environment as well as strategies to improve biopharmaceuticals CMC. Has experience in product and process life cycle management, continuous improvement, innovation, and financial acumen.
·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
·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
·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
·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
·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
This job posting excludes CO applicants.
·Additional Job Description
Additional Job Description
·Represent GMSci and CMC in global product governance for at least two commercial products
·Lead a cross functional CMC subteam defining and driving effective submission support and life cycle management activities for at least two products within Takeda’s commercial biologics portfolio
·Provide strong leadership for LCM initiatives, submission plans, and investigations which are complex or span across multiple products.
·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.
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.