Senior Scientist, Small Molecule Formulations

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: February 23, 2021

Job Description:

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 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 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, Novato , Senior Scientist, Small Molecule Formulations, Other , Novato, California