Associate Engineering Fellow, Process Engineering
Company: Takeda Pharmaceutical
Location: Cambridge
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 DescriptionSynthetic Molecule Process Development
(SMPD) is responsible for the development of robust, sustainable,
and cost-effective processes for the manufacture of new synthetic
molecule pharmaceuticals, along with methods for achieving and
controlling high standards of purity and quality. -The successful
candidate will be recognized as a technical resource/expert within
SMPD and across Pharmaceutical Sciences and utilize his/ her
technical expertise to contribute across multiple projects, drive
technical/scientific strategy and mentor junior engineers. The
Associate Engineering Fellow will be leading complex programs and
will be responsible for all aspects of reaction & particle
engineering, including the development of scale down models for the
study of unit operations, process safety evaluation as well as
technical transfer to external contract manufacturing
organizations. He or she will be collaborating closely with the
Chemistry and Technology groups to apply enabling & emerging
development and manufacturing technologies and will be responsible
for helping shape the department's technology roadmap, based on
pipeline needs and current trends in research. -The ideal candidate
will have deep experience in using process analytical technologies
(PAT) in combination with mathematical models (both statistical &
first principle) to enhance process understanding to effectively
develop/ optimize/ scale-up and troubleshoot processes. The
Associate Engineering Fellow will have experience with building
scale-down equipment and developing innovative advanced process
control strategies for both batch and continuous processes. The
ideal candidate will strive to continuously improve how pipeline
projects are supported and will be developing new workflows to
facilitate and accelerate process development, optimization and
understanding as well as technical transfer to manufacturing,
leveraging digital tools, automation, robotics and/ or cobotics. He
or she will represent Takeda with universities/industrial consortia
and drive the group's publication strategy. -How you will
contribute:
- Develops project and/ or significant technical strategy and
leverages technical skill(s) as a resource/expert within the
department.
- Collaborates closely with cross-functional teams, including
process chemistry, analytical development, drug product
development, manufacturing, quality assurance, and regulatory
affairs, to develop and implement effective process engineering
strategies.
- Drives process optimization initiatives to improve
sustainability, process efficiency, yield, quality, and
cost-effectiveness, utilizing expertise in process chemistry and
fundamental engineering principles.
- Oversees process scale-up activities from laboratory to pilot
plant and commercial-scale production, ensuring smooth technology
transfer and process validation.
- Has full accountability for all engineering aspects for complex
pipeline projects.
- Initiates complex projects with extraordinary technical
challenges and applies strong technical risk assessment
skills.
- Owns a discipline/technical skill in its entirety and continues
to develop expertise in other key technical skills.
- Conducts analysis of technical and conceptual risk through
robust process characterization, failure mode analysis, and risk
assessment methodologies, identifies trends and defines and
champions process or scientific strategies.
- Benchmarks current trends in R&D and manufacturing
technologies.
- Incorporates novel manufacturing, technologies, and industry
trends as a key aspect of scientific strategy development.
- Leads small working groups as appropriate to address knowledge
gaps in programs linking departmental strategy to strategies of
other relevant functions.
- Identifies topics for initiatives and leads local/global
initiatives on behalf of senior staff.
- Recognized as a technical leader/resource by the group and
fosters development of technology skill sets within department and
among junior staff.
- Acts as a mentor to junior staff.
- Leads the development of novel solutions for complex
cross-functional data analysis, modeling, and engineering
challenges.
- Contributes to departmental strategy around scientific
improvement and new capabilities.
- Coordinates and leads technology transfer to internal or
external manufacturing sites or vendors.
- Communicates with senior management of other functions on
implementation of infrastructure, technology, work processes, or
business processes.
- Responsible for authoring relevant sections of regulatory
documents, validation plans, development reports, process flow
diagrams (PFDs), piping and instrumentation diagrams (P&IDs),
process descriptions and peer reviewed manuscripts.
- Defines outsourcing strategy for department in conjunction with
senior staff.
- Proactively identifies vendors and builds relationships to gain
access to technologies as needed to deliver against pipeline
goals.
- Attends pertinent workshops and conferences. Belongs to a
national professional society, actively participates in local and
national activities. Presents scientific posters or podia
internally and externally to Takeda. Authors internal reports of
publication quality and co-authors publishable manuscripts.
Represents Takeda in relationships with universities and industrial
consortia. Is an inventor on invention disclosures and patents.
Authors publications. Contributes to and drives publication
strategy within department. Establishes recognition as scientific
leader within Takeda. -Minimum Requirements/Qualifications:
- A Ph.D. degree with 7+ years of pharmaceutical industry
experience; an MS degree with 13+ years of pharmaceutical industry
experience; or a BS degree with 15+ years of pharmaceutical
industry experience. Degrees in chemical engineering required
- Extensive experience in the use of mathematical, both
statistical and first principle, models as well as advanced process
control systems preferred.
- Extensive experience in building reaction kinetic models as
well as process models preferred.
- Extensive experience in building laboratory and pilot plant
equipment preferred.
- Experience in crystallization process development and scale-up
with an emphasis on polymorph, purity and particle size control a
plus.
- Experience in the use and scale-up of milling technologies
(both dry and wet) for particle size control preferred.
- Experience in the use of process analytical technologies
(FT-IR, NIR, FBRM, UV-vis, etc.) required.
- Experience in building chemometric models preferred.
- Experience in developing continuous processes a plus.
- Sound knowledge of current Good Manufacturing Practices
(cGMP).
- Experience working in a pilot plant a plus.
- Previous experience with the use of contract facilities and
managing technical transfers.
- Experience in working in a multi-disciplinary team
environment.
- Significant technical and strategic leadership and
accomplishments
- Previous experience contributing to regulatory filings,
preferably experience with late-stage filings.
- Proven scientific track record through presentations at
scientific conferences and publication of peer reviewed
manuscripts. -Knowledge and Skills:
- Able to troubleshoot critical issues or problems and determine
the causes and possible solutions
- Ability to work well on global cross-functional team.
- Ability to expresses oneself clearly and concisely within team;
documents issues and/or concerns concisely and comprehensively;
adjusts communication style as appropriate for the audience timely
and effectively communicates with senior management; technical
writing skills to support authorship of internal/external and
approval of internal technical documents
- Excellent time management and prioritization skills to balance
several project and departmental objectives
- Recognized specialist in defined scientific area or areas
- 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
- Demonstrated involvement in professional community evidenced by
presentation of scientific posters or lectures at professional
conferences or events and communicating new scientific trends.
Interacts with external vendors for projects
- Develops and uses knowledge and interpersonal skills to
appropriately influence and guide others towards the accomplishment
of department/function goals and objectives 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.Takeda 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:Cambridge,
MAU.S. Base Salary Range:$149,100.00 - $234,300.00The 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.LocationsCambridge, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Brookline , Associate Engineering Fellow, Process Engineering, Engineering , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...