CMC Lead, Manufacturing Sciences
Company: Takeda Pharmaceutical
Location: Pepperell
Posted on: May 11, 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 Privacy Notice and 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
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 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, Nashua , CMC Lead, Manufacturing Sciences, Other , Pepperell, New Hampshire
Click
here to apply!
|