Head, Analytical Controls (Senior Director)
Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: September 23, 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 DescriptionHow you will contribute:
- Lead and develop a global team of managers and scientists and
their teams in the field of analytical controls and compliance
- Global CMC program oversight of Pharmaceutical Sciences (PS)
with management and oversight of all 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 from Research to
Commercialization by collaborating with multiple functions within
the Pharmaceutical Science organization to improve analytical,
process and product knowledge. Including the support of transfer of
development assets from Research, main ownership starting 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.
- Implement and execute externalization activities with external
partners, facilitate development of execution plans for each, and
ensure completion of agreed upon activitiesAccountabilities: - - -
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- 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
- Lead and implementation of wider cross-functional/cross
divisional strategy and decisions and drives initiatives to
completion.
- Develops and manages strategies for regional and global
departmental infrastructure, resources, projects, etc. in
conjunction with senior staff and global line and function
heads
- Lead global CMC and Quality key initiatives and represent Pharm
Sci to other cross functional stakeholder key initiatives
- Analyze and synthesize concepts from diverse information -and
articulate
- Develop and set vision and direction of departmental activities
and infrastructure with specific focus but not limited to
compliance, quality, systems and processes for AD and PS
- In collaboration with commercial functions, develop and
implement strategies to control quality of drug substances and
products based on the current Good/Laboratory/Manufacturing
Practice (cGMP, cGLP) regulations
- Harmonization and standardization of AD but also PS processes,
reporting, systems and documents in collaboration with Quality.
Establishes and manages operational processes within the
department/function.
- Benchmarks current trends within industry for all areas within
Analytical Controls also including strategic development and
planning of system architecture in alignment and collaboration with
partners and stakeholders e.g. GMS/GQ for company wide systems, IT
and PSST for new solutions.
- Look for external benchmarks that help to aid superior
performance of products, processes and people
- Manages complete line function responsibility for all
departmental programs and initiatives
- Demonstrates project oversight and leadership and
cross-functional awareness to advance the line function regionally
and globally
- Directs, informs and applies outsourcing strategy for
department in conjunction with senior staff and global line and
function headsMinimum Requirements/Qualifications:
- Bachelor degree with 20+ years of experience
- Advanced degree with 15+ years relevant industry experience - -
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- Minimum of 10 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
- Excellent command of English (all sites). -
- 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
improvementTakeda 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.comNo Phone Calls or Recruiters
Please.#LI-KD1Takeda 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:Cambridge, MAU.S. Base Salary
Range:$205,100.00 - $322,300.00The 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.LocationsCambridge, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cambridge , Head, Analytical Controls (Senior Director), Executive , Cambridge, Massachusetts
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