Associate Director, Analytical Development, Bioanalytics Late Stage
Company: Takeda Pharmaceutical
Location: Lexington
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 DescriptionObjective / Purpose:As an Associate
Director in Analytical Development, it is expected that the
individual will independently lead efforts in development of
appropriate scientific methods and technology, implementation of
evolving scientific technology, drive team objectives and manage
team performance in line with Pharmaceutical Sciences' strategy to
deliver on program strategy and initiatives. The individual is
expected to have acquired expertise in benchmarking analytical
development trends within industry and demonstrate an in-depth
working knowledge of Pharmaceutical Sciences and other partner
organizational (Research, GMSGQ) roles and program strategy. -
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- Expected to independently conduct technical analyses and risk
assessments to build knowledge of processes, methods, and to inform
related strategies across program and potentially across
Pharmaceutical Sciences especially for Bioanalytics for late stage
Biologics programs
- Manage staff with accountability for performance and talent
development
- Works with senior management to develop and set vision for
departmental activities and management of resources.
- Ownership of Bioanalytics late stage area, responsible for
establishing and managing operational processes within the
department and influencing scientific and process improvement in
global AD.
- Strong knowledge of ICH and other regulatory guidelines
including Analytical Quality by Design (AQbD)
- Experience in reviewing and approving analytical-related CMC
sections of BLA/MAA regulatory submissions. Knowledgeable in
European, Japanese, Chinese and US CMC regulatory requirements for
Biologics
- Represents AD and provide guidance to PST teams by leveraging
cross program learning, demonstrating ability to understand and
communicate impact of technical and project risks on program
timelines and other PS functions
- Reviews and interprets complex data, industry trends and
incorporates into strategy to communicate clearly to PS functional
leadership and partner functional leadership as appropriate.
- Driving vendors and sourcing/consultancy strategy both
internally and externally.
- Responsible for developing AD skill set to enable department
vision, and management of team performance, engaging with external
professional/scientific community, may drive publication
strategy
- Complete all required training appropriate to role and function
in a timely mannerEducation & Competencies:
- Bachelors degree with 15+ yrs relevant experience, Masters
degree with 13+ yrs relevant experience, Ph.D. with 7+ yrs relevant
experience
- Provides technical/managerial leadership for analytical
function, in-depth understanding of PS deliverables and program
timelines, driving program strategy, demonstrating leadership in
functional and cross functional teams
- Able to communicate to cross functional senior leadership on
technology implementation strategy, able to lead or contribute in
cross functional teams and ways of working, provide guidance around
project leadership and strategy to team members as well as
technical guidance -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.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:Lexington, MAU.S. Base Salary
Range:$149,100.00 - $234,300.00The 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.LocationsLexington, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Brookline , Associate Director, Analytical Development, Bioanalytics Late Stage, Executive , Lexington, Massachusetts
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