Staff Engineer / Senior Staff Engineer - Biologics Process Development
Company: Takeda Pharmaceutical
Location: Charlestown
Posted on: May 16, 2022
|
|
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 Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge.
Job DescriptionJob DescriptionAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a Staff Engineer / Senior
Staff Engineer - Biologics Process Development (Viral Vector
Purification Focus) 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, you will be a vital
contributor to our inspiring, bold mission.
POSITION OBJECTIVES:Provides theoretical/conceptual input to the
design, development and execution of research assignments for a
specific project or projects within the functional area.
Independently plans and executes most unit operation
characterization and optimization experiments within expertise and
develops an awareness of unit operations in other areas.The role
will have cross-functional leadership opportunities on high
visibility projects. Responsible for significant or sole technical
leadership within project or complex study. Prepares technology
transfer documentation, regulatory documents, and reports or
coordinates with team members to ensure execution. Represents line
functions on CMC teams as appropriate/necessary. Proactively
identifies process or study issues/challenges and proposes
potential resolutions.Develops project or significant technical
strategy within area of expertise. Leverages technical skill(s) as
a resource/expert within the department. Identifies and plans
broader technical objectives (project and scientific related) and
initiates processes meet objectives with input from manager as
needed. Identifies and recommends vendors as appropriate.
Coordinates cross-functional teams and resolutions, with a focus on
scientific /technical challenges.
POSITION ACCOUNTABILITIES:The role will have cross-functional
leadership opportunities on high visibility projects. The
successful candidate will lead interns/co-ops and potential future
contractors. Develops and leverages strategic understanding of
project and CMC priorities to plan/coordinate with cross-functional
peers and evaluate impact of decisions across CMC and other
development functions. Contributes significantly 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.The Staff Engineer / Senior Staff
Engineer - Biologics Process Development reviews, interprets, and
communicates data cross functionally within CMC and project teams.
Coordinates with others in creating technical reports including
reviewing and editing. Conducts analysis of technical and
conceptual risk and trends. Identifies process trends and
defines/champions 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.
Represents functional area on project teams by communicating
activities from designated functional area to project team.
Identifies topics for initiatives and leads local/global
initiatives as directed by senior staff. Ensures a productive and
development-rich environment; provides training/mentoring for
junior staff. Defines more complex/novel approaches and
methodologies to solving complex technical challenges . Proactively
identifies vendors and builds relationships to gain access to
technologies as needed to deliver on pipeline goals. Manages key
vendor relationships across multiple projects as appropriate, and
proactively affects resolution of issues arising at vendors.
Initiate and influence project direction outside department.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:PhD in
chemistry, biology, pharmacy, engineering or related pharmaceutical
science; 0-3 years relevant industry experience Master's degree in
chemistry, biology, pharmacy, engineering or related pharmaceutical
science; 3-5 years relevant industry experience Bachelor's degree
in chemistry, biology, pharmacy, engineering or related
pharmaceutical science and 7-10 years relevant industry experience
Technical expertise in downstream process development of biologics,
viral vector experience is a plus. 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 is a plus Experience in working in a multi-disciplinary
team environment Previous experience contributing to regulatory
filings
TECHNICAL FOCUS AREA/SPECIFIC QUALIFICATIONSThe position will be a
key contributor within a group responsible for upstream and
downstream process development. In support of purification process
development the group performs the following activities:
small-scale experiments, scale-up, technology transfer and support
for programs that bring new bio-pharmaceutical products to
pre-clinical, clinical, and commercial manufacturing phases. The
candidate will design and carry out experiments for purification
process development, optimization and characterization studies for
therapeutic proteins. The scope includes IND- and BLA-enabling
studies and preparation of regulatory submissions. The experimental
studies involve both lab scale and pilot plant runs, including, but
not limited to toxicology, clinical, and validation batches.This
person must have extensive knowledge and experience on
phase-appropriate purification process development and associated
unit operations, including:Product harvesting (clarification and
capture) from production bioreactors Purification from mammalian
sources (adherent and/or suspension) Purification of different
biologic modalities: Viral vectors (LV, gRV, etc.), Non-Fc
recombinants, MAbs, and Fc-fusion proteins Chromatography (IEX,
Affinity, HIC, Mixed-mode) Filtration (depth filtration,
sterilizing filtration, ultrafiltration/diafiltration) Familiarity
with cell culture processes and analytical characterization of
proteins is preferred.The candidate must have experience in design
of experiments, process monitoring, process risk assessment,
statistical analysis and the ability of interpreting data and
deriving conclusions. The candidate must demonstrate excellent
written and verbal communication skills. Contributes to the
preparation of CMC sections of regulatory filings. Authors and
reviews high quality technical reports and presentations for
management and peers. Independently refers to procedures, policies
and practices for guidance. Contributes to publications in the
field of expertise. Knowledge of cGMP manufacturing is
required.
Knowledge and Skills:Analytical and Problem Solving Skills - Able
to troubleshoot critical issues or problems using appropriate
information and, determine causes and possible solutions Teamwork -
Ability to work well on global cross-functional teams.
Communication Skills -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 Organization - Exercises
good time management and prioritization skills to balance multiple
project and departmental objectives Technical - Subject matter
expertise in a specific scientific area or areas. Demonstrated
ability to successfully contribute across multiple scientific
endeavors Knowledge Sharing - 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 Resource Management -Project management skills;
ability to manage one's time within individual, departmental, and
corporate goals and timelines; management of internal external
resources (vendors) External Involvement - Demonstrated involvement
in professional community evidenced by presentation of scientific
posters or lectures at professional conferences or events.
Interacts with external vendors for projects Leadership Skills -
Develops and uses knowledge and interpersonal skills to
appropriately influence and guide others towards the accomplishment
of department/function goals and objectivesTRAVEL REQUIREMENTS:May
require approximately 10% travelEffective November 1, 2021, absent
an approved religious or medical reason, all US office-based and
lab-based Takeda employees who work fully on-site or in a hybrid
model (as determined by Takeda) must be fully vaccinated to work at
a Takeda site or to engage with Takeda colleagues or anyone else on
behalf of Takeda. As of the same date, absent an approved religious
or medical reason..... click apply for full job details
Keywords: Takeda Pharmaceutical, Boston , Staff Engineer / Senior Staff Engineer - Biologics Process Development , Other , Charlestown, Massachusetts
Click
here to apply!
|