CMC Lead, Manufacturing Sciences
Company: Takeda Pharmaceutical
Location: Lexington
Posted on: August 7, 2022
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Job Description:
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Job Description
ACCOUNTABILITIES
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:
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.
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
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.
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
Lexington, MA
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Boston , CMC Lead, Manufacturing Sciences, Other , Lexington, Massachusetts
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