Head, Analytical Development (AD)
Company: Takeda
Location: Boston
Posted on: November 20, 2023
Job Description:
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Job Description
Are you looking for a patient-focused company to inspire you and
support your career? If so, be empowered to take charge of your
future at Takeda. Join us as the Head, Analytical Development (AD)
in Pharmaceutical Sciences.
At Takeda, we are transforming the pharmaceutical industry through
our R&D-driven market leadership and being a values-led
company. To do this, we empower our people to work towards their
potential through life-changing work. Certified as a Global Top
Employer, we offer stimulating careers and work towards excellence
in everything we do. We foster an inclusive, collaborative
workplace, in which our global teams are united by an unwavering
commitment to deliver Better Health and a Brighter Future to people
around the world.
Here, you will be a vital contributor to our inspiring, bold
mission.
Objectives/Purpose:
- P rovides leadership and expertise in physical/chemical,
biopharmaceutical, biological and parenteral testing for the
discovery and development of small and large molecules and other
modalities and delivery mechanisms . This includes managing the
resources and analytical strategies for development and testing a
portfolio of development candidates across many modalities
.
- Sets the strategic direction for the function including
(including regulatory, technical, and financial strategies) and is
responsible for the management of all CMC analytical testing a
ctivities for the global R&D portfolio including the e stablish
ment of GMP labs for release testing of clinical trial materials
and management of a network of external development and testing
providers.
- D eveloping R &D CMC analytical center s of excellence
which will provide strategic analytical testing capabilities in
line with Takeda's R&D portfolio from discovery to post
approval . This position will also determine and support new areas
of analytical science and related technologies for potential use in
new methods .
- Ensures that analytical methods are properly validated for the
stage of development, the analytical data that the methods generate
d a r e reliable and compliant with regulatory authorities, and
that the methods are ultimately transferable to commercial
organizations around the world .
Accountabilities:
- Accountable to the entire R&D Organization for providing
high quality data that is reliable and will be used by R&D
project teams to make critical decisions including go-no-go for
projects based on the physicochemical, biopharmaceutical,
pre-formulation and stability data provided.
- O verall strategic management, direction, and motivation of
physical, chemical, biopharmaceutic and analytical testing
professionals that are responsible for the advancement of R&D
projects.
- O perate s across the global PS network and collaborate s with
other functions both within and outside Takeda to meet PS , R&D
and Takeda objectives .
- Provides GMP and GLP reliable testing methods and analytical
testing data for IND/CTA to NDA/MAA submissions in countries across
the world that will serve as the basis for marketing
approval.
- Develops and implement s strategies to reliably control the
quality of drug substances and products based on the current Good
Manufacturing Practice (cGMP) regulations in collaboration with
Takeda's quality organization.
- Develops and maintain s a competent organization that will
encourage appropriate risk taking, empowerment and the development
of individuals.
- Manages a 45+ oku yen analytical testing budget within the
human resources required to perform the work to achieve the
department's critical results .
- Provides input into the overall strategic plans of the
Pharmaceutical Sciences organization and for the implementation of
key decisions from the Pharmaceutical Science's Leadership Team
into the normal activities of AD.
- Accountable for the performance and management of analytical
testing sites across the major geographical regions and using these
sites to efficiently meet the goals of PS , R& D and the commercial
organizations.
- Leads effective and efficient outsourcing of GLP/GMP analytical
testing and the implementation and sustainability of internal
GLP/GMP testing in early development .
- Accountable for the development, implementation, and
realization of the digital CMC testing strategy across the R&D
testing organization including LIMS, PAT, RTR, Met hod Simulation,
and other aspects of digital data from CMC testing
Dimensions and Aspects:
Technical/Functional (Line) Expertise :
- Comprehensive understanding of the pharmaceutical industry and
Analytical Development
- In-depth knowledge of US/EU/JP regulatory regulations and ICH
requirements governing international pharmaceutical
industries
- Experience d in development of analytical / bioanalytical
programs and strategies for both early and late-stage product
development
- Demonstrated experience with the preparation of analytical CMC
sections of regulatory submissions
- Sets a high compliance standard and ensures that systems and
resources are in place to ensure the activities of the laboratories
(internal and external) are conducted in compliance with cGMP/GLPs,
SOPs, good documentation practices, DEA regulations and safety
standards and in accordance with corporate requirements. Ensures
overall laboratory readiness for regulatory inspections (e.g., FDA,
EMA and DEA) and internal audits.
Leadership:
- Demonstrated ability to work across functions, regions, and
cultures
- Enterprise level leadership with the ability to inspire,
motivate and drive results
- Excellent communicator, able to persuasively convey both ideas
and data, verbally and in writing
- Proven skills as an effective team player who can engender
credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple
comprehensible terms
- Executive leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and
role models these behaviors for the organization
- Ability to develop and drive a Global Workforce and Talent
strategy for all 200 + colleagues in the Global, Regional and Local
organizations
Decision-making and Autonomy :
- Ability to make highly complex decisions that impact the
enterprise
- Accountable for decision making for designated function
(Analytical Development)
- Ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are made
swiftly to yield flawless execution
- Accountable for designing and implementing vision and strategy
for designated scope in alignment with organizational goals
Interaction :
- Effectively navigates the changing external and internal
environment and leads others through change by creating and
inspiring and engaging workplace
- Ability to effectively implement R&D's partnership
strategy
- Effectively represent Takeda in High-level negotiations with
the ability to resolve conflict in a constructive manner
- Ability to build strong partnerships and drive role clarity
with other interfacing Takeda functions
Innovation :
- Visionary and forward thinking with the ability to influence
and effectively drive organizational change and continuous
innovation
- Comfortable challenging the status quo and bringing forward
innovative solutions
- Ability to take risks implementing innovative solutions,
accelerating time to market
Complexity :
- Ability to work in a global ecosystem (internal and external)
with a high degree of complexity
- Breadth of knowledge required across therapeutic areas,
indications, and/or modalities
Education, Behavioral Competencies and Skills:
- Bachelor's degree in chemistry, Biology, Analytical science, or
related field . PhD preferred.
- Minimum of 15+ years of increasing responsibility and
experience in pharmaceutical analysis, manufacturing, or laboratory
environment
- Minimum of 10 years of analytical research experience in the
pharmaceutical industry, including at least 3+ years of analytical
laboratory management.
- At least 5+ years of Senior management experience in Analytical
Development or related field, leading a medium to large
organization and influencing senior-level management and key
stakeholders
- Proven track record of leading and driving business process
transformation and organizational culture change as well as
delivering on programs with complex business deliverables
- Operational experience in pharmaceutical drug development with
significant direct exposure to clinical development
- Track record of successful leadership, management, and
development of large, multi-disciplinary globally dispersed teams.
Strong judge of talent with the ability to make tough talent
decisions.
- Health care business acumen with a comprehensive understanding
of the pharmaceutical industry
Additional Information:
- Pharmaceutical manufacturing and packaging
- Active pharmaceutical ingredient manufacturing
- Packaging materials
- Printed commodities
- Analytical laboratories
Approximately 15% travel is required .
Domestic and international flights with overnight stays
required
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy
Base Salary Range: $240,100.00 to $343,000.00, based on candidate's
professional experience level. Employees may also be eligible for
Short-Term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
Plan
- Tuition reimbursement Company match of charitable
contributions
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs
Takeda is proud in its commitment of 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.
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
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
Boston, MA
AUT - Vienna - K--rntner Ring
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda, Boston , Head, Analytical Development (AD), Other , Boston, Massachusetts
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