Staff Engineer / Senior Staff Engineer - Biologics Process Development
Company: Takeda Pharmaceutical
Location: Reading
Posted on: May 9, 2022
Job Description:
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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 filingsTECHNICAL
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, 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.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 ProgramsEmpowering Our People to
ShineDiscover more at -takedajobs.comNo Phone Calls or Recruiters
PleaseThis job posting excludes CO applicantsTakeda 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.#LI-LLP1 -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, Somerville , Staff Engineer / Senior Staff Engineer - Biologics Process Development , Other , Reading, Massachusetts
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