Scientist - Analytical Development (AD) - Late Development
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 DescriptionAbout the role:At Takeda, we are a
forward-looking, world-class R&D organization that unlocks
innovation and delivers transformative therapies to patients. By
focusing R&D efforts on four therapeutic areas and other
targeted investments, we push the boundaries of what is possible in
order to bring life-changing therapies to patients worldwide.Join
Takeda as a Scientist - Analytical Development (AD) - Late Stage
Development - where you will independently lead efforts in
development of analytical methods, implementation of evolving
scientific technology and influences strategic planning within AD
and across Pharmaceutical Sciences to deliver on program strategy
and initiatives. You will also prepare and coordinate completion of
technology transfer documentation, CMC sections of regulatory
documents, or validation plans and reports within expertise for
review. As part of the Analytical Development team, you will report
to Associate Director, Analytical Development.How you will
contribute:
- Develop and leverage strategic understanding of project and CMC
priorities to plan/coordinate with cross-functional peers and
evaluate impact of decisions across CMC functions and other
development functions.
- Contribute to complex/multiple projects or functional areas
through leading or influencing others.
- Influence and support initiatives related to driving scientific
and technical improvement within a function and potentially
cross-functionally.
- Review, interpret, and communicate data cross functionally
within CMC and project teams.
- Coordinate with others in creating technical reports including
reviewing and editing.
- Conduct analysis of technical and conceptual risk and
trends.
- Identify process trends and define process strategy or use of
novel technologies.
- Recognized as a technical expert and resource within
function.
- Significant technical responsibility for a project
area/technical program within the department and potentially across
CMC.
- Represent functional area on CMC project teams by communicating
activities from designated functional area to project team.
- Integrate scientific/technical efforts around cross-functional
issues.
- Identify topics for initiatives and may lead local/global
initiatives as directed by senior management.
- Ensure a productive and development-rich environment; Serve as
a technical resource or mentor for junior staff and leverage
expertise in laboratory technology as a functional
resource/trainer.
- Define more complex/novel approaches and methodologies to
solving complex technical challenges.
- Identify vendors and build relationships to gain access to
technologies as needed to deliver pipeline goals.
- Manage key vendor relationships across projects as appropriate,
and affect resolution of issues arising at vendors.
- Initiate and influences project direction outside
department.
- Prepare and review technical reports and regulatory filing
documentation.
- Coordinate cross-functional teams and resolutions, with a focus
on scientific /technical challenges.Minimum
Requirements/Qualifications:
- Bachelors degree in chemistry, biology, pharmacy, or related
pharmaceutical science and 8+ years relevant industry
experience
- Masters degree in chemistry, biology, pharmacy, engineering or
related pharmaceutical science and 6+ years relevant industry
experience
- PhD in chemistry, biology, pharmacy, engineering or related
pharmaceutical science
- Experience in CMC pharmaceutical development for active
pharmaceutical ingredients and drug products under cGMP's
- Sound knowledge of current Good Manufacturing Practices
(cGMP)
- Experience with the use of contract facilities
- Experience contributing to regulatory filings
- Have developed expertise in multiple areas of analytical
technology and demonstrate an in-depth working knowledge of program
strategy. Experienced with working on late-stage assets and with
various regulatory agencies
- Knowledge of analytical techniques with advanced experience in
multiple techniques such as LC, GC, MS, dissolution, particle size
analysis, etc.; Able to work in a lab setting and independently
interpret results of complex experiments and integrate data
produced by other disciplines
- Experience with a variety of method development, validation,
and transfer; Ability to design and direct analytical strategy to
meet CMC project objectives
- Able to coordinate resources (internal/external) to support a
project
- Experience with analytical testing for liposome or LNP or other
complex formulations preferred
- Able to expresses oneself clearly and concisely within team;
documents issues and/or concerns concisely with colleagues; adjusts
communication style as appropriate for the audience; timely and
effectively communicates with senior management; has sound
technical writing skills to support authorship and approval of
internal technical documents.
- Subject matter expertise in a specific scientific area or
areas. Demonstrated ability to successfully contribute across
multiple scientific endeavors
- Ability to capture knowledge within the organization; improves
solutions, processes, and deliverables through use of information;
improves information capital by contributing experience, theories,
deliverables, and models for others to use
- Demonstrated involvement in professional community evidenced by
presentation of scientific posters or lectures at professional
conferences or events preferredMore 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.#LI-SB1Takeda
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:$108,500.00 - $170,500.00The 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, Brockton , Scientist - Analytical Development (AD) - Late Development, Other , Boston, Massachusetts
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