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Senior Scientist, Drug Product Development

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Company :
Takeda

Location :
Boston, Massachusetts

Expiry Date :
Fri, 06 Nov 2020 23:59:59 GMT

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Job_Description

Are you looking for a patient-focused company that will inspire you and support
your career? If so, be empowered to take charge of your future at Takeda. Join
us as a Senior Scientist, Drug Product Development in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-
driven market leadership and being a values-led company. To do this, we empower
our people to realize their potential through life-changing work. Certified as
a Global Top Employer, we offer stimulating careers, encourage innovation, and
strive for excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an unwavering
commitment to deliver Better Health and a Brighter Future to people around the
world.

Here, everyone matters and you will be a vital contributor to our inspiring,
bold mission.

As a Senior Scientist working in the Drug Product Development team, you will be
empowered to design, execute and/or manages phase appropriate formulation and
process development studies encompassing all activities from early phase
formulation to manufacturing process validation.

OBJECTIVES/PURPOSE

The Senior Scientist is expected to provide technical leadership on product
development activities encompassing different modalities including small
molecules, microbiome, oligonucleotides and peptides. The Senior Scientist is
responsible for independently planning and execution of drug product
development activities including Drug Discovery support, Pre-formulation,
Formulation/Process Development, Tech Transfer, Clinical Manufacturing and
Regulatory Filing supports. The Senior Scientist line function on
Pharmaceutical Sciences teams and will provide theoretical/conceptual input to
the design, development and execution of research assignments for drug product
development.

ACCOUNTABILITIES
* Designs, executes and/or manages phase appropriate formulation and
process development studies encompassing all activities from early phase
formulation to manufacturing process validation with inputs from manager
as needed.
* Manage CROs and CMOs to support drug product development and GMP
manufacturing of the drug product.
* Responsible for drug product manufacturing activities at CMO s
including master batch records, protocols GMP manufacturing, batch
release, deviations, investigations, CAPA s and change controls.
* Author/review internal development reports, CMC sections of IND/IMPD/NDA
and responses in support of regulatory filings/queries.
* Represent DPD group on cross functional CMC teams and leverage strategic
understanding of the project and CMC priorities to plan/coordinate the
drug product development studies with cross-functional peers.
* Provide project progress updates/reports to manager to ensure management
is engaged and aware of the project strategy, current activities and
future needs.
* Serves as subject matter expert and contributes actively to complex/
multiple projects or functional areas through leading or influencing
others.
* Lead and support departmental (or cross functional) key initiatives to
drive scientific and technical innovations.
* Ensures a productive, respectful and development-rich environment;
provides training/mentoring for junior staff.
* Proactively identifies vendors and builds relationships to gain access to
technologies as needed to deliver on pipeline goals.

DIMENSIONS AND ASPECTS
* Comprehensive understanding of the pharmaceutical industry and Cell
Therapy

Leadership
* Demonstrated ability to work across functions, regions and cultures
* Enterprise level leadership with the ability to inspire, motivate and
drive results
* Excellent communicator, able to persuasively convey both ideas and data,
verbally and in writing
* Proven skills as an effective team player who can engender credibility
and confidence within and outside the company
* Ability to distil complex issues and ideas down to simple comprehensible
terms
* Executive leadership presence and confidence
* Embraces and demonstrates a diversity and inclusion mindset and role
models these behaviors for the organization
* Ability to develop and drive a Global Workforce and Talent strategy for
all colleagues in the Global, Regional and Local organizations

Decision-making_and_Autonomy
* Broad decision-making responsibilities
o Ability to make highly complex decisions that impact the enterprise
o Accountable for decision making for Cell Therapy
o Ability to seek diverse input from multiple constituents and
stakeholders to drive innovative solutions
o Ability to incorporate feedback and ensure decisions are made
swiftly to yield flawless execution
* Accountable for designing and implementing vision and strategy for
designated scope

Interaction
* Effectively navigates the changing external and internal environment and
leads others through change by creating and inspiring and engaging
workplace
* Ability to effectively implement R&D s partnership strategy
* Effectively represent Takeda in High-level negotiations with the ability
to resolve conflict in a constructive manner
* Ability to build strong partnerships and drive role clarity with other
interfacing Takeda functions

Innovation
* Visionary and forward thinking with the ability to influence and
effectively drive organizational change and continuous innovation
* Comfortable challenging the status quo and bringing forward innovative
solutions
* Ability to take risks implementing innovative solutions, accelerating
time to market

Complexity
* Ability to work in a global ecosystem (internal and external) with a high
degree of complexity
* Breadth of knowledge required across therapeutic areas, indications, and/
or modalities

Education,_Behavioral_Competencies_And_Skills
* Must have a degree in a related scientific discipline.
* BS with at least eleven (11) years, MS/PharmD with at least nine (9)
years or a PhD with a minimum of three (3) years of experience in Product
Development in the Pharmaceutical industry is required.
* Extensive experience and demonstrated track record in several drug
product development activities such as Drug Discovery support, Pre-
formulation, Early phase formulation development, formulation
characterization, manufacturing process development, tech transfer, scale
up and validation.
* Technical expertise in development of oral or parenteral products with
demonstrated experience in one or more formulation techniques including
but not limited to solubilization, spray drying, hot melt extrusion,
nanoparticles, dry/wet granulation, tablet compression, Wurster process,
tablet coating, encapsulation, liquid fill/finish and aseptic processing.
* Good working knowledge of common analytical techniques such as HPLC, DSC,
TGA, XRPD, IR/Raman spectroscopy and particle size analysis techniques.
* Extensive experience in CMC pharmaceutical development for drug products
under cGMP s.
* Previous experience contributing to regulatory filings.
* Ability to work independently, take initiatives, and complete tasks to
meet the deadlines.
* Strong team player.
* Must be capable of handling multiple projects with competing timelines
and must be able to make complex decisions.
* Must possess solid communication skills as well as organizational skills.
* Demonstrated leadership skills Develops and uses knowledge and
interpersonal skills to appropriately influence and guide others towards
the accomplishment of department/function goals and objectives.

Additional_Information
* Requires occasional travel to various meetings or vendor sites
* Some international travel may be required
* Hands-on laboratory work is required

Travel_Requirements
* May require approximately 10% – 20% travel

What_Takeda_Can_Offer_You
* 401(k) with company match and Annual Retirement Contribution Plan
* Tuition reimbursement Company match of charitable contributions
* Health & Wellness programs including onsite flu shots and health
screenings
* Generous time off for vacation and the option to purchase additional
vacation days
* Community Outreach Programs

Empowering Our People to Shine

Discover more at

No Phone Calls or Recruiters Please

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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