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Senior Research Associate II, Biologics Drug Product Development

Company: Ultragenyx Pharmaceutical
Location: San Francisco
Posted on: February 25, 2021

Job Description:

Senior Research Associate II, Biologics Drug Product Development 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--onboarding. Position Summary ultradedicated - Your biggest challenges yield rare possibilities 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 Associate Director/Senior 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 level. Responsibilities including, but not limited to:

  • Design and 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 characterization activities.
  • 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.-- Requirements:
    • Degree in Biochemistry, Chemistry, Chemical Engineering, BioEngineering, Pharmaceutical Sciences or a related discipline.
    • MS with 4+ years or BS with 6+ years industry working experience.
    • 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 highly desired.
    • 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--talentacquisition@ultragenyx.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 to:--talentacquisition@ultragenyx.com .

Keywords: Ultragenyx Pharmaceutical, San Francisco , Senior Research Associate II, Biologics Drug Product Development, Other , San Francisco, California

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