(Senior) Technical Operations Engineer
Company: Principia Biopharma Inc.
Posted on: May 31, 2021
At Kiadis Pharma, a Sanofi Company, we are leveraging the
natural strengths of humanity and our collective immune systems to
source the best cells for life. Our NK cell (natural killer cell)
research and development programs and partnerships are at the
cutting-edge of the industry, paving the way for new and exciting
therapies, in immuno-oncology and beyond.
In support of developing our innovative NK cell therapies, we
are looking for a (Senior) Technical Operations Engineer,
home-based in the United States (preferably East Coast).
As a (Senior) Technical Operations Engineer, you are part of the
Technical Operations Team which is responsible for ensuring the
reliability, capacity, and quality of the Kiadis manufacturing
operations at our US based Contract Manufacturing Organizations
(CMOs). Together with your colleagues you manage and optimize
existing production processes and technologies, by monitoring and
understanding their performance and leading improvement
opportunities. In addition, you are responsible for the resolution
of escalated process deviations or investigations. In your
day-to-day work you will:
Define and manage manufacturing-related change controls, quality
events, and CAPAs.
Manage and improve the technology knowledge on processing and
manufacturing in collaboration with your Process Development
colleagues. Act as subject matter expert and proactively identify
new trends and opportunities.
Provide expert support, guidance, and training to production
staff related to technology, process, aseptic handling.
Help assess the feasibility of new equipment, processes, and
changes to established processes or equipment and lead the
Represent the manufacturing organization during the development
of new processes. Lead risks assessments, GAP assessments, the "fit
for manufacturing/process fit to plant" process.
Monitor process performance together with Quality Assurance, and
Process Development. Including Identifying and proposing the
resulting required changes.
Select raw material suppliers and perform impact assessments of
vendor changes in collaboration with Quality Assurance,
Manufacturing, and Process Development.
As needed, supports the review of incoming material related
Acts as a subject matter expert towards the Process Development
team and process monitoring activities
- Collaborate with Quality Assurance to secure the release of
clinical materials, and review and approve of cGMP
The Kiadis Operations team is responsible for all aspects of CMC
development, manufacturing, procurement, planning, and customer
service within Kiadis. We are a group of experienced professionals
- cell therapy experts, biologists, engineers, analysts,
manufacturing technicians, and more, driven by the passion to
develop and supply innovative cell therapy products, directly to
patients. We work through a global network of internal and external
laboratories and production facilities and interact on a daily
basis with apheresis centers and hospitals around the world. Join
us and see for yourself how your talent and skills will bring us
closer to our ultimate goal: helping patients worldwide.
The ideal candidate
We are looking for someone who shares our love for cells and
process technology and likes being part of a dynamic organization.
Someone that is an excellent team player and communicator, has a
strong sense of quality, and is pragmatic. In addition, we are
looking for someone with the following requirements:
BSc or MSc in cell biology, biotechnology, bioprocess
technology, or a related field.
Minimum of 3 years of working experience in a relevant field,
preferably in industrial cell therapy, biologics, vaccines, or
upstream biologics manufacturing.
Strong understanding of state-of-the-art practice in biologics
or the cell therapy field
Strategic forward-thinking manner, with the ability to
communicate with people at all levels of an organization.
Self-directed with a strong operational focus.
Organized, bringing focus and structure into projects.
Fluency in English, other languages are a plus.
- Availability to travel up to 10% to CMOs/contractors and to AMS
What we offer
People from all over the world, together as one team, contribute
to improving the lives of patients every day. We offer an exciting
position in an innovative, dynamic, and inspiring environment where
you'll receive a competitive remuneration package, autonomy, and
the opportunity to make your own mark within Kiadis.
We create an environment where ideas are shared, experiences are
impactful, and talent is developed. Because of our inclusive and
family-like environment, you will always have the feeling of
belonging & appreciation.
At Sanofi diversity and inclusion is foundational to how we
operate and embedded in our Core Values. We recognize to truly tap
into the richness diversity brings we must lead with inclusion and
have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
Keywords: Principia Biopharma Inc., Framingham , (Senior) Technical Operations Engineer, Other , Framingham, Massachusetts
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