Downstream Staff Engineer
Company: Takeda Pharmaceutical
Location: Framingham
Posted on: May 12, 2022
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Job Description:
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Job Description
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a Staff
Engineer - Biologics Process Development (Purification Focus) in
our Lexington, 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 work towards 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.
OBJECTIVES:
Provide theoretical/conceptual input to the design, development and
execution of research assignments for a specific project or
projects within the functional area. Independently plan and execute
most unit operation characterization and optimization experiments
within expertise and develops an awareness of unit operations in
other areas.
You will have cross-functional leadership opportunities on high
visibility projects. Responsible for significant or sole technical
leadership within project or complex study. Prepare technology
transfer documentation, regulatory documents, and validation plans
and reports or coordinates with team members to ensure execution.
Represent line functions on CMC teams as appropriate/necessary.
Proactively identifies process or study issues/challenges and
proposes potential resolutions.
Develop 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.
ACCOUNTABILITIES:
Understand project timelines and deliverables and plans/coordinates
project work accordingly with departmental, functional, and
external stakeholders
Provide technical leadership to project teams within area of
expertise and commits resources to execute specific project
tasks.
Contribute significantly and independently to project work which
may within functional area.
Review, interprets, and communicates data cross-functionally within
CMC and project teams.
Plan and implement resolutions to technical problems/issues
Represent functional area on GCT project teams by communicating
activities from designated functional area to project team
Support local and global initiatives which may include leading
initiatives or work streams
Serve as a technical resource for junior staff and leverages
expertise in laboratory technology as a functional
resource/trainer.
Independently designs and executes experiments, and reports
results
Helps develop project strategy and communicates complex
data/decisions within department and cross functionally as
necessary
Build and maintain relationships with key vendors and assists with
technical aspects of vendor negotiations
Analyze manufacturing issues and coordinates potential resolution
with the CMC team.
Integrate scientific/technical efforts around cross-functional
EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
Required:
Bachelor's degree in chemistry, biology, pharmacy, engineering or
related pharmaceutical science and 8+ years relevant industry
experience
Master's degree in chemistry, biology, pharmacy, engineering or
related pharmaceutical science; 6+ years relevant industry
experience
PhD in chemistry, biology, pharmacy, engineering or related
pharmaceutical science; 0+ years relevant industry experience
Bachelor's: 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 in working in a multi-disciplinary team environment
Previous experience contributing to regulatory filings
PhD: Demonstrated mastery of subject or area related to field
Knowledge and Skills:
Analytical and Problem Solving Skills - Able to troubleshoot
critical issues or problems, and determine causes and possible
solutions
Teamwork -- Ability to work well in cross functional team
environment and across global line functions.
Communication Skills -Able to expresses one's self concisely within
team; documents issues and/or concerns with colleagues; adjust
communication style for the audience; timely and effectively
communicates issues to supervisor; technical writing skills to
support authorship of internal technical documents
Organization - Exercise good time management and prioritization
skills and can manage multiple tasks simultaneously
Knowledge Sharing - Ability to capture organizational knowledge;
improve solutions, processes, and deliverables through use of
information; improve information capital by contributing
experience, theories, deliverables, and models for others to
use
Resource Management -Ability to manage one's time within
individual, departmental, and corporate goals and timelines;
management of all resources (vendors)
External Involvement - Demonstrated involvement in professional
community evidenced by presentation of scientific posters or
lectures at professional conferences or events
Technical - Subject matter expertise of applicable lab equipment
and operations
TRAVEL REQUIREMENTS:
May require approximately 5-10% travel.
LINE FUNCTION SPECIFIC QUALIFICATIONS
The 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.
You will 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 both microbial and mammalian sources
Purification of different biologic modalities: Non-Fc recombinants,
MAbs, and Fc-fusion proteins
Chromatography (IEX, Affinity, HIC, Mixed-mode)
Filtration (depth filtration, viral filtration, sterilizing
filtration, ultrafiltration/diafiltration)
Familiarity with cell culture processes characterization of
proteins.
You must have experience in design of experiments, process
monitoring, process risk assessment, statistical analysis and the
ability of interpreting data and deriving conclusions. You must
demonstrate excellent written and verbal communication skills.
Contribute to the preparation of CMC sections of regulatory
filings. Author and review high quality technical reports and
presentations for management and peers. Independently refer to
procedures, policies and practices for guidance. Contribute to
publications in the field of expertise. Knowledge of cGMP
manufacturing is required.
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
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, US field-based employees, employees
must be fully vaccinated in order to continue in their current
roles. US employees who work at a Takeda manufacturing facility,
and those who work at a BioLife center or BioLife lab, may be
subject to different guidelines. Candidates are encouraged to speak
with their recruiter to seek further information on the applicable
guidelines for the Business Unit/Function for which they have
applied.
Empowering Our People to Shine
Discover more at takedajobs.com
This job posting excludes CO applicants.
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No Phone Calls or Recruiters Please.
Takeda 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.
EEO Statement
Takeda 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.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Framingham , Downstream Staff Engineer, Engineering , Framingham, Massachusetts
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