Research Associate II / Senior Research Associate I, Biologics Drug Product Development
Company: Ultragenyx Pharmaceuticals
Location: South San Francisco
Posted on: May 3, 2021
Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real
impactful action to care for the needs of patients and our people
is always the right thing to do. To achieve this goal, our vision
is to lead the future of rare disease medicine. For us, this means
going where other biopharma companies won't go - challenging the
status quo and creating a new model that advances our field so more
patients and caregivers can benefit from life-changing treatments.
We do this by following the science, applying a novel rapid
development approach, making innovative medicines at fair and
reasonable prices, and creating a collaborative ecosystem to reach
patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so
culture is an essential cornerstone for Ultragenyx. We remain
continuously focused on creating a supportive and inclusive
environment of profound learning and growth - so employees can
thrive in all areas of their lives, in and outside of work.
Ultimately, we want to be an organization where we would be proud
for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of
your career, and grow a lot, both professionally and personally,
come join our team. During the COVID-19 Outbreak, we are committed
to our hiring process. The health and safety of our employees and
prospective employees take priority which means at this time our
approach will include video discussions, interviews, and
ultradedicated - Your biggest challenges yield rare
In this role, you will develop formulation and support process
development activities for Ultragenyx's growing nucleic acid
therapy and biologic pipeline. This position will report to the
Principal Scientist of Biologics Drug Product Development in the
Technical Development group. You will contribute to the Drug
Product/Formulation function in CMC development teams to enable
successful regulatory filings of new biologics. You will play a key
role in the internal mRNA and protein drug product process
development capability at Ultragenyx. This role is based in
Brisbane, CA. Job title is dependent on candidate's experience
- Design / perform lab-based experiments and activities to
develop drug product formulations and manufacturing processes for
Ultragenyx's mRNA and protein products.
- Document laboratory experiments and results in lab notebooks
and summarize findings in technical reports as needed.
- Conduct drug product process optimization and process
- Author relevant drug product sections in regulatory filings and
address agency questions.
- Provide formulation and molecule support for Translational
Research projects as appropriate.
- Follow all safety and compliance regulations and company
policies at work.
- Title commensurate with education and experience.
- Degree in Biochemistry, Chemistry, Chemical Engineering,
BioEngineering, Pharmaceutical Sciences or a related
- RA II: MS with 0+ years or BS with 2+ years industry working
- SRA I: MS with 2+ years or BS with 4+ years industry working
- Must have knowledge of analytical instrumentation used in
formulation development such as SEC, DSC, fluorescence, UV-visible
spectrometry, CE, MFI, HIAC, light scattering.
- Must have hands-on experience in formulation and process
development for proteins and oligonucleotide molecules, including
pH, buffer and excipient screening, stress stability studies,
- Must have excellent problem solving skills and verbal and
written communication skills.
- Solid knowledge on oligonucleotide molecules, direct hands-on
experience with mRNA nanoparticles research and characterization is
- Experience in DOE statistical approach in formulation and
process development is desired.
- Familiar with fill-finish process optimization and clinical
compatibility studies is a plus
- Ability to lift 50 pounds.
Ultragenyx Pharmaceutical is an equal opportunity employer &
prohibits unlawful discrimination based on race, color, religion,
gender, sexual orientation, gender identity/expression, national
origin/ancestry, age, disability, marital and veteran status.
Reasonable accommodation will be provided for qualified individuals
with disabilities and for qualified disabled veterans in job
application procedures, as required by applicable law. If you have
any difficulty using our online application system and need an
accommodation due to a disability, you may contact Talent
Acquisition by calling: (415) 483-8800 or by emailing us at
email@example.com. For electronic email and mail
inquiries, please include a description of your requested
accommodation, your name and contact information.
See our CCPA Employee and Applicant Privacy Notice.
Note to External Recruiters: All candidate activity and open
positions are managed strictly through our Human Resources
Department. Our Human Resources Department kindly requests that
recruiters not contact employees/hiring managers directly in an
attempt to solicit business and present candidates. Please note
that failure to comply with this request will be a factor in
determining a professional relationship with our organization.
Submission of unsolicited resumes prior to an agreement set in
place between the Human Resources Department and the recruiting
agency will not create any implied obligation. Inquiries on
developing a recruiting relationship with us, may be directed to:
Keywords: Ultragenyx Pharmaceuticals, South San Francisco , Research Associate II / Senior Research Associate I, Biologics Drug Product Development, Other , South San Francisco, California
Didn't find what you're looking for? Search again!