CMC Lead, Manufacturing Sciences
Company: Takeda Pharmaceutical
Location: Pepperell
Posted on: May 13, 2022
Job Description:
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's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionACCOUNTABILITIES -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.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
organizationDecision-making and Autonomy - - - - - - - - - Full
accountability for complex decisions regarding the LCM strategy,
CMC priorities and Technology Excellence for the products under
his/her responsibilityInteraction - - - - - - - - - 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 teamInnovation - - - - - - - - - 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
approachesComplexity - - - - - - - - - Manages with a matrix of
reporting lines and across functional areas - - - - - - - - -
Provides leadership to drive highly complex projects involving
across multiple sites and productsEDUCATION, 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 initiativesSkills - - - - - -
- - - 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 futureThis job posting excludes CO applicants. - -
- - - - - - - Additional Job DescriptionAdditional 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 StatementTakeda 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.LocationsLexington,
MABoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time
Keywords: Takeda Pharmaceutical, Nashua , CMC Lead, Manufacturing Sciences, Other , Pepperell, New Hampshire
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