Senior Scientist, Analytical Development Brisbane, CA 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.
Position Summary: The Senior Scientist, Analytical Development will lead the analytical development activities of Ultragenyx pipeline projects, including monoclonal antibodies, proteins, and other therapeutic modalities.
Responsible for analytical method development/qualification, product characterization, and IND/BLA document preparation.
This position will report to the Executive Director, Analytical Development.
He/she will contribute to execute in-house analytical studies, coordinate in-house and outsourced analytical work, and in partnership with Technical Development and Quality colleagues to play a key role in the development of Ultragenyx's biotherapeutics.
Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities: Lead development and qualification of physical chemical analytical methods for in-process, drug substance and drug product characterization, release, and stability testing, support extended characterization studies for biologics.
Manage analytical method transfers to CMOs/CROs for clinical phase GMP testing, and support process technology transfer to c GMP CMOs.
Work closely with team members in analytical development and quality control, as well as other functions such as Manufacturing, CMC team, Project Development and Regulatory, to ensure the timely development, validation, testing and release of materials to be used to support clinical activities.
Author and review protocols, technical reports, method SOPs, method qualification documents, analytical sections of IND and BLA/MAA regulatory submissions.
Contribute to laboratory and manufacturing investigations, develop and execute experiments in the laboratory as needed.
Collaborate effectively with other functions, including process development, manufacturing, quality control, quality assurance, manufacturing, regulatory affairs etc.
Support CMC assessment of in-licensing opportunities and technology opportunities.
Requirements: Ph D/MS/BS in chemistry, biochemistry, molecular biology, or chemical engineering with analytical development experience in the Pharmaceutical or Biotechnology industry; Ph D a minimum of 5-8 years; or MS a minimum of 8-10 years; or BA/BS a minimum of 10-12 years related experience.
Hands-on experience in analytical method development for biologics including HPLC, CE and/or mass spectrometry-based methods.
Solid understanding of product characterization of biologics, including monoclonal antibodies and proteins.
Thorough technical understanding of early and late-stage development of biologics products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
Strong records of successful INDs, and preferably with BLAs and MAAs experience.
Management experience of internal lab, contract manufacturing sites, and contract analytical labs.
Excellent written and verbal communication skills; Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
Ability to engage collaboratively with CMC functions and external testing laboratories.
The typical annual salary range for this full-time position is listed below.
This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting.
The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range: $152,000 - $187,700 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: Generous vacation time and public holidays observed by the company.
Long term incentive and Employee stock purchase plans or equivalent offerings.
Fitness reimbursement.
* Benefits vary by region and country.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws.
Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs.
Applicants can request an accommodation prior to accepting a job offer.
If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at Apply for this job * indicates a required field #J-18808-Ljbffr