Senior Scientist - Analytical Development (AD) Synthetic Molecules - Early 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 Senior Scientist - Analytical Development (AD)
Synthetic Molecules - Early Development - where you will provide
and drive theoretical/conceptual input to the design, development
and execution of research assignments for a specific project or
projects within the functional area to drive efficient progress to
early regulatory agency filings. You will also leverage analytical
technical skill(s) as a resource/expert within Analytical
Development, and be responsible for significant or sole technical
leadership within project or complex studies. As part of the
Analytical Development team, you will report to Director,
Analytical Development.How you will contribute:
- Develops project and technical strategy within area of
expertise.
- 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.
- Prepare and coordinate completion of technology transfer
documentation, CMC sections of regulatory documents, or validation
plans and reports within expertise for review.
- Coordinate transfer of projects as necessary within Takeda or
externally.
- Identify and plan broader technical objectives (project and
scientific related) with input from manager as needed.
- Identify and recommend vendors as appropriate.
- Coordinate cross-functional teams and resolutions, with a focus
on scientific /technical challenges.
- Contribute to complex/multiple projects or functional areas
through leading or influencing others.
- Influences and supports initiatives related to driving
scientific and technical improvement within function and
potentially cross-functionally.
- Review, interpret, and communicate data cross functionally
within CMC and project teams.
- Coordinate 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 (e.g. CMC team AD representative or team lead).
- 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 lead local/global
initiatives as directed by senior staff.
- Ensure a productive and development-rich environment; Serves as
a technical resource or mentor for junior staff and uses 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.
- Manages key vendor relationships across multiple projects as
appropriate, and affects resolution of issues arising at
vendors.
- Initiate and influence project direction outside
department.
- Prepare and review technical reports and regulatory filing
documentationMinimum Requirements/Qualifications:
- Bachelors degree in chemistry, biology, pharmacy, or related
pharmaceutical science and 11+ years (Sr. Scientist) or 8+ years
(Scientist) relevant industry experience
- Masters degree in chemistry, biology, pharmacy, engineering or
related pharmaceutical science; 9+ years (Sr. Scientist) or 6+
years (Scientist) relevant industry experience
- PhD in chemistry, biology, pharmacy, engineering or related
pharmaceutical science; 3+ years (Sr. Scientist) relevant industry
experience
- Extensive experience in CMC pharmaceutical development for
active pharmaceutical ingredients and drug products under
cGMP's
- Sound knowledge of current Good Manufacturing Practices
(cGMP)
- Previous experience with the use of contract facilities
- Experience working in a multi-disciplinary team
environment
- Previous experience contributing to regulatory filings
- Able to expresses one's self 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; 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; improve
solutions, processes, and deliverables through use of information;
improve information capital by contributing experience, theories,
deliverables, and models for others to use.
- Project management skills; ability to manage one's time within
individual, departmental, and corporate goals and timelines;
management of internal external resources (vendors)
- Demonstrated involvement in professional community evidenced by
presentation of scientific posters or lectures at professional
conferences or events preferred (Snr Scientist)
- Leadership Skills (Sr. Scientist) - Develops and uses knowledge
and interpersonal skills to appropriately influence and guide
others towards the accomplishment of department/function goals and
objectives
- Strong knowledge of analytical techniques with advanced
experience in multiple techniques such as LC, GC, CE, MS,
dissolution, etc.
- Able to work in lab setting
- Experience representing Analytical Development in a cross
functional CMC environment
- Proven experience with a variety of method development,
validation, and transfer;
- Ability to design and direct analytical strategy to meet CMC
project objectives.
- Experience in preparing regulatory documentation.More 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:$133,000.00 - $209,000.00The 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 , Senior Scientist - Analytical Development (AD) Synthetic Molecules - Early Development, Other , Boston, Massachusetts
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