DESCRIZIONE/REQUISITI |
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At Genmab, we’re committed to building
extra[not]ordinary futures together, by
developing antibody products and pioneering,
knock-your-socks-off therapies that change
the lives of patients and the future of
cancer treatment and serious diseases. From
our people who are caring, candid, and
impact-driven to our business, which is
innovative and rooted in science, we believe
that being proudly unique, determined to be
our best, and authentic is essential to
fulfilling our purpose.
The Role & Department
In Genmab’s expansive growth, we are now
looking for a Drug Product Subject Matter
Expert (SME) to take upon the responsibility
within the area of Compatibility and In-use
for Genmab’s portfolio products. You will
work closely together with early/late stage
project teams as well as Drug Supply and
subject matter experts within the Science &
Technology team. As a Drug Product SME
specializing in Compatibility and In-Use, you
will play a pivotal role in ensuring the
integration of our pharmaceutical products
within various healthcare environments.
Leveraging your expertise in drug product
formulation, you will assess compatibility
with delivery systems, storage conditions,
and patient needs.
You will be joining the "Pharmaceutical
Development and Product Support" team in the
Late Stage Manufacturing Development (LSMD)
department in CMC operations. LSMD currently
has 25 team members and is responsible for
the late stage development activities of
Genmab’s portfolio projects and preparation
of the CMC package for regulatory filings.
Key responsibilities include
- Oversight of Compatibility and In-use
strategies for early/late stage clinical
development programs to ensure alignment with
product objectives and regulatory
requirements
- Responsible for Compatibility and In-use
studies conducted for Genmab portfolio
projects, incl. preparing/reviewing protocols
and reports
- Responsible for providing expert guidance
and recommendations for Compatibility and In-
use inquiries (in-side/out-side Genmab)
- Collaborate with cross-functional teams as
Medical and Clinical to integrate
Compatibility and In-use considerations into
product development plans
- Support authoring and review of relevant
CMC regulatory submissions documents for
Compatibility and In-use
- Responsible for CMC input to clinical trial
documents such as IMP/Pharmacy manual
- Support DP late stage development
activities, incl. formulation development,
drug product process characterization and
validation activities
- Support DP activities performed at our
partnered CMOs
Requirements
- Master’s degree in natural science,
pharmacy or similar
- You have at least 5-10 years of documented
professional experience with chemistry,
manufacturing, and controls (CMC) biologics
product development in the Biopharmaceutical
industry
- You have active experience within drug
product formulation, Compatibility and In-use
studies and a solid understanding of
regulatory requirements
- Experience with multiple delivery systems
is a plus
- You preferably have experience with
lifecycle management and medical information
requests
- Excellent communication skills in English
written and oral
Moreover, you meet the following professional
requirements:
- You are focused on achieving goals that are
important for the team and our
organization
- You have the ability to work successfully
under pressure in a fast-paced environment
and with tight timelines
- You are pro-active, take initiative and
responsibility
You are a team player with demonstrated
ability to collaborate with a diverse group
of internal and external stakeholders
- With your positive attitude, you enjoy
working in multicultural teams inside and
outside of Genmab
This role is located in Copenhagen, Denmark.
About You
- You are passionate about our purpose and
genuinely care about our mission to transform
the lives of patients through innovative
cancer treatment
- You bring rigor and excellence to all that
you do. You are a fierce believer in our
rooted-in-science approach to problem-
solving
- You are a generous collaborator who can
work in teams with diverse backgrounds
- You are determined to do and be your best
and take pride in enabling the best work of
others on the team
- You are not afraid to grapple with the
unknown and be innovative
- You have experience working in a fast-
growing, dynamic company (or a strong desire
to)
- You work hard and are not afraid to have a
little fun while you do so
Locations
Genmab leverages the effectiveness of an
agile working environment, when possible, for
the betterment of employee work-life balance.
Our offices are designed as open, community-
based spaces that work to connect employees
while being immersed in our state-of-the-art
laboratories. Whether you’re in one of our
collaboratively designed office spaces or
working remotely, we thrive on connecting
with each other to innovate.
About Genmab
Genmab is an international biotechnology
company with a core purpose guiding its
unstoppable team to strive towards improving
the lives of patients through innovative and
differentiated antibody therapeutics. For
more than 20 years, its passionate,
innovative and collaborative team has
invented next-generation antibody technology
platforms and leveraged translational
research and data sciences, which has
resulted in a proprietary pipeline including
bispecific T-cell engagers, next-generation
immune checkpoint modulators, effector
function enhanced antibodies and antibody-
drug conjugates. To help develop and deliver
novel antibody therapies to patients, Genmab
has formed 20+ strategic partnerships with
biotechnology and pharmaceutical companies.
By 2030, Genmab’s vision is to transform the
lives of people with cancer and other serious
diseases with Knock-Your-Socks-Off (KYSO™)
antibody medicines.
Established in 1999, Genmab is headquartered
in Copenhagen, Denmark with locations in
Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and
inclusion
We are committed to fostering workplace
diversity at all levels of the company and we
believe it is essential for our continued
success. No applicant shall be discriminated
against or treated unfairly because of their
race, color, religion, sex (including
pregnancy, gender identity, and sexual
orientation), national origin, age,
disability, or genetic information. Learn
more about our commitments on our website.
Genmab is committed to protecting your
personal data and privacy. Please see our
privacy policy for handling your data in
connection with your application on our
website https://www.genmab.com/privacy.
How to apply: Directly at this website
https://genmab.wd3.myworkdayjobs.com/en-
US/Genmab_Careers_Site/details/Subject-
Matter-Expert--Drug-Product_R10311?
locationCountry=49ab063f422741e2aef271de00efe
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