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Senior Scientist, Small Molecule Formulations

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: May 3, 2021

Job Description:



Senior Scientist, Small Molecule Formulations

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 wont 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 ourapproachwill includevideo discussions, interviews, andonboarding.

Position Summary

ultra focused Work together to fearlessly uncover new possibilities

You will lead formulation and process development for Ultragenyxs 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. Position can be based in Novato, CA or Brisbane, CA.

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 agency questions. 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 small molecules. Experience in DOE statistical approach in formulation and process development. Working knowledge of quality and regulatory requirements of small molecule products including ICH guidelines. Experience working with contract manufacturing organizations is preferred. 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 contactTalent Acquisitionby calling:(415) 483-8800or byemailingus 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, Novato , Senior Scientist, Small Molecule Formulations, Other , Novato, California

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