Downstream Manufacturing Science, MSAT Engineer II/III
Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 13, 2023
Job Description:
Overview
The work we do at FDB has never been more important-and we are
looking for talented candidates to join us. We are growing our
locations, our capabilities, and our teams, and looking for
passionate, mission-driven people like you who want to make a real
difference in people's lives. Join FDB and help manufacture the
next vaccine, cure, or gene therapy in partnership with some of the
most innovative biopharma companies across the globe. We are proud
to cultivate a culture that will fuel your passion, energy and
drive - what we call Genki.We are growing our locations and are
investing more than $2 billion into establishing a new--large-scale
manufacturing site for biopharmaceuticals in the United States to
accelerate the growth of our Bio CDMO (Contract and Development
Manufacturing Organization) business. This will be the largest
end-to-end CDMO provider in North America. The new site will offer
end-to-end solutions--to our customers looking to manufacture
biopharmaceuticals in the US. In addition to drug substance
manufacture, it will also--provide--automated fill-finish and
assembly, packaging, and labeling services. The new
state-of-the-art facility is located in Holly Springs, North
Carolina, United States.The Downstream Manufacturing Science team
is part of the Process Science department which provides
engineering and scientific leadership to support both clinical and
commercial processes in the area of protein purification
operations. The Process Science team act as leads in process
transfers, are Subject Matter Experts for manufacturing processes,
responsible for scale up/scale down of processes as well as other
projects. Cross functional collaboration throughout the entire
organization is an important part of our everyday work. The
department continuously strives to identify opportunities to
improve systems and practices and provides direction to the
manufacturing organization. As a Manufacturing Science
Scientist/Engineer, you will be a part of a dedicated team with
highly competent colleagues focusing on downstream operations. You
will be involved in multi-disciplinary projects working in close
collaboration with team members and/or in cross functional project
groups. This position provides a unique and exciting opportunity to
use your breadth and depth of experience in upstream development
and manufacturing to shape the future of the manufacturing science
team in this $2B large scale manufacturing site.--
External US
Responsibilities:
- Lead and support technology transfer teams, including execution
of laboratory experiments and guiding implementation of process
parameters or controls for manufacturing processes.
- Provide technical risk assessments for new manufacturing
processes.
- Develop project plans, timelines, and communication forums to
ensure a smooth tech transfer.
- Provide comprehensive written manufacturing protocols and
reports summarizing investigations, studies and projects.
- Provide interpretation of manufacturing data, analyse
laboratory- or manufacturing data to solve manufacturing
problems.
- Set up analysis of manufacturing process performance and
reporting to manufacturing management.
- Coordinate, plan and execute/support manufacturing process
validation runs.
- Training of manufacturing staff and members of the
manufacturing sciences group on new processes and procedures.
- Capability to absorb and utilize new knowledge quickly and
drive data-based decisions.
- Closely collaborate with our Downstream manufacturing
department to support commercial/clinical programs running in the
manufacturing.
- Use a data-driven approach for Root cause investigations, data
analysis and impact assessments for deviations.
- Write documentation for internal and external use such as
manufacturing campaigns summary reports, PPQ protocol/reports,
impact assessments etc.
- Support continuous improvement projects, in partnership with
manufacturing where applicable, to improve manufacturability,
reliability, yield and cost.
- Support of supplier technical evaluations, risk assessments,
and raw material evaluation and qualification.Requirements:
- Master's degree or a BS/BA in a scientific or engineering
field.-- You have 5+ years of experience, depending on educational
background (Bachelor, Masters), within tech transfers in
biopharmaceutical or related field with a broad background in
protein purification and biologics manufacturing
- Prior drug substance manufacturing experience, including
process validation, process transfer, commercialization, and
manufacturing support and troubleshooting
- Strong attention to detail, highly organized and the ability to
multitask in a fast-paced, highly interactive environment.
- Experience communicating and collaborating
cross-functionally
- Excellent verbal and written communication, as well as
presentation skills
- Flexible, organized and solution-oriented mindset.
- Self-motivated and capable of working with a high degree of
independency as well as having a positive attitude and being
proactive.
- Able to travel, domestic and international (approximately
10-20%)FDBN works with technical data, technology and materials
that are subject to U.S. export laws and regulations. This position
will require access to technical data, technology and source code
that is controlled under U.S. export laws and regulations,
including but not limited to the International Traffic in Arms
Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration
Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To
conform to these laws and regulations, applicants must be U.S.
citizens, lawful permanent residents of the U.S., protected
individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and
refugees) or otherwise eligible for an export authorization from
the U.S. Department of State or U.S. Department of Commerce. Offers
of employment will be contingent on the Company's ability to secure
an export authorization.FDBN is an Equal Opportunity Employer. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin,
disability, protected veteran status, sexual orientation, gender
identify or any other protected class. If an accommodation to the
application process is needed, please email
glenna.gonzalez@fujifilm.com.To all agencies: Please, no phone
calls or emails to any employee of FUJIFILM about this requisition.
All resumes submitted by search firms/employment agencies to any
employee at FUJIFILM via-email, the internet or in any form and/or
method will be deemed the sole property of FUJIFILM, unless such
search firms/employment agencies were engaged by FUJIFILM for this
requisition and a valid agreement with FUJIFILM is in place. In the
event a candidate who was submitted outside of the FUJIFILM agency
engagement process is hired, no fee or payment of any kind will be
paid.
Keywords: FUJIFILM Holdings America Corporation, Cary , Downstream Manufacturing Science, MSAT Engineer II/III, Engineering , Holly Springs, North Carolina
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