Director, Analytical Controls US
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 22, 2024
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 DescriptionOBJECTIVES: -
- Lead and develop a team of managers and scientists in the field
of analytical controls and compliance
- Global CMC program oversight of Pharmaceutical Sciences (PS)
with management and oversight of all local project-related
analytical control topics, development requirements and program
milestones including global reporting
- Oversee and manage core tasks for Analytical controls for
clinical trial material efforts across four main areas a) GMP
review and control for analytical documents b) Release testing
oversight, Stability and Shelf life c) Reference Standard
Management d) GMP Quality Systems
- Contribute to product development and product quality oversight
from Research to Commercialization by collaborating with multiple
functions within the Pharmaceutical Science organization to improve
analytical, process and product knowledge and control. Including
the support of transfer of development assets from Research, main
ownership commencing at start of GMP activities until hand-over to
the commercial organization.
- Contribute to overall functional direction globally and
represent function within CMC/Pharmaceutical Science and across the
global Takeda organization.ACCOUNTABILITIES:
- Responsibility for people and group management. Inspire
confidence in team members and lead the organization culture,
promoting a healthy and inclusive working environment. Build future
leadership while mentoring direct reports and junior
employees.
- Demonstrates project oversight and leadership and
cross-functional awareness to advance the line function regionally
and globally. Close alignment and collaboration with other global
AC leads in Japan and EU.
- Manages complete line function responsibility for all
departmental programs and initiatives. Provides strategic guidance
across projects that involve extraordinary, well-considered
risks.
- Approve regulatory submission relevant sections, PS usage and
justification documents (when applicable)
- Contributes and manages strategies for regional and global
departmental infrastructure, resources, projects, etc. in
conjunction with senior staff and global line and function
heads
- Support and implementation of wider cross-functional/cross
divisional strategy and decisions and drives initiatives to
completion. Support of global CMC and Quality key initiatives and
representation of PharmSci to other cross functional stakeholder
key initiatives
- Analyze and synthesize concepts from diverse information -and
articulate
- Contribute and drive vision and direction of departmental
activities and infrastructure with specific focus but not limited
to compliance, quality, systems and processes for AD and PS
- Focus on harmonisation and standardisation of AD but also PS
processes, reporting, systems and documents in collaboration with
Quality. Establishes and manages operational processes within the
department/function.
- In collaboration with commercial functions, develop and
implement aligned strategies to control quality of drug substances
and products based on the current Good/Laboratory/Manufacturing
Practice (cGMP, cGLP) regulations
- Benchmarks current trends within industry for all areas within
Analytical Controls also including strategic development in
alignment and collaboration with partners and stakeholders
- Directs and manages outsourcing strategy for department in
conjunction with senior staff and global line and function
headsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree and 18+ years relevant industry experience -
-
- Masters and 16+ years relevant industry experience - - -
- PhD and 10+ years relevant industry experience - -
- Minimum of 7 years of experience working in CMC analytical
development area for active pharmaceutical ingredients and drug
products under cGMP's
- Demonstrates effective project management skills
- GMP and compliance experience required
- Analytical method development experience required
- Regulatory submission experience required with basic knowledge
for regulatory guidelines
- Global cultural awareness, manage inclusively
- Familiarity with working in a global setting (Specific skills
required follows)
- Excellent command of English (oral and written)
- People managerial experience preferred
- Team player with flexible personality but able to be persistent
and assertive
- Highly reliable, self-motivated, responsible and curious
personality open to learn and develop and a pronounced desire for
improvementMore about us:At Takeda, we are transforming patient
care through the development of novel specialty pharmaceuticals and
best in class patient support programs. Takeda is a patient-focused
company that will inspire and empower you to grow through
life-changing work.Certified as a Global Top Employer, Takeda
offers stimulating careers, encourages innovation, and strives for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.Takeda Compensation and Benefits
SummaryWe understand compensation is an important factor as you
consider the next step in your career. We are committed to
equitable pay for all employees, and we strive to be more
transparent with our pay practices. -For Location:Boston, MAU.S.
Base Salary Range:$169,400.00 - $266,200.00The estimated salary
range reflects an anticipated range for this position. The actual
base salary offered may depend on a variety of factors, including
the qualifications of the individual applicant for the position,
years of relevant experience, specific and unique skills, level of
education attained, certifications or other professional licenses
held, and the location in which the applicant lives and/or from
which they will be performing the job.---The actual base salary
offered will be in accordance with state or local minimum wage
requirements for the job location. -U.S. based employees may be
eligible for short-term and/ or long-term incentives. U.S. based
employees may be eligible to participate in medical, dental, vision
insurance, a 401(k) plan and company match, short-term and
long-term disability coverage, basic life insurance, a tuition
reimbursement program, paid volunteer time off, company holidays,
and well-being benefits, among others. U.S. based employees are
also eligible to receive, per calendar year, up to 80 hours of sick
time, and new hires are eligible to accrue up to 120 hours of paid
vacation. -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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Medford , Director, Analytical Controls US, Executive , Boston, Massachusetts
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