Senior Scientist, Small Molecule Formulations
Company: Ultragenyx Pharmaceutical
Posted on: February 23, 2021
Senior Scientist, Small Molecule Formulations Ultragenyx is a
commercial-stage biopharmaceutical company committed to developing
novel therapies for the treatment of rare and ultra-rare genetic
diseases. The company has rapidly built a diverse portfolio of
small molecule, monoclonal antibody, mRNA and gene therapy
candidates with the potential to address debilitating genetic
diseases for which the unmet medical need is high, the biology for
treatment is clear, and for which there are typically no approved
therapies treating the underlying disease.-- Developing new
treatments for rare genetic diseases is challenging work. It takes
courage, talent, and dedication to look past the easy answers and
uncover new solutions that can make a meaningful impact. At
Ultragenyx we push each other to perform at our very best, because
we never lose sight of our mission - to make a difference in our
patients' lives. Come join our team during this exciting time of
growth and opportunities! 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 process will include WebEx video discussions,
interviews & onboarding. Position Summary ultrafocused - Work
together to fearlessly uncover new possibilities You will lead
formulation and process development for Ultragenyx's small molecule
products. You will report to the Senior Director, Small Molecule
Process in Technical Development, and represent the drug product
development function in CMC development teams to enable successful
regulatory filings of new products. Responsibilities including, but
not limited to:
- Develop drug product formulations, dosage forms and
manufacturing processes for small molecule products.
- Conduct process optimization, scale-up, tech transfer, and
process characterization activities.
- Collaborate with other functional areas in the CMC project team
to deliver project milestones on time and within budget.
- Work with CROs and CMOs and manage their activities to ensure
timely delivery of high-quality work.
- Author relevant sections in regulatory filings and address
- Support Manufacturing Management and Quality in deviation
investigations and product life cycle management.
- Support Translational Research as a technical consultant.
- Follow all safety and compliance regulations and company
policies at work. Requirements:
- Degree in Chemistry, Chemical Engineering, Pharmaceutical
Sciences or a related discipline.
- PhD with 5+ years' relevant working experience, or MS with 12+
years, or BS with 15+ years.
- Hands-on experience in formulation and process development for
- Experience in DOE statistical approach in formulation and
- Working knowledge of quality and regulatory requirements of
small molecule products including ICH guidelines.
- Experience working with contract manufacturing organizations is
- Experience in both early stage and late stage development is
desired. #LI-CV1 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
email@example.com . For electronic email and
mail inquiries, please include a description of your requested
accommodation, your name and contact information. 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
Keywords: Ultragenyx Pharmaceutical, Novato , Senior Scientist, Small Molecule Formulations, Other , Novato, California
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