Director, Analytical Development at Ultragenyx in 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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Analytical Development will lead the analytical development activities of Ultragenyx pipeline projects, include 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 set analytical strategy, coordinate in-house and outsourced analytical work, and in partnership with Technical Development and Quality colleagues to play key role in the development of Ultragenyx’s biotherapeutics.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Lead the analytical development activities for early and late-stage Programs
Lead development and qualification of physical chemical analytical methods for in-process, drug substance and drug product characterization, release, and stability testing
Manage analytical method transfers to CMOs/CROs for clinical phase GMP testing, and support process technology transfer to cGMP CMOs
Manage relationships with existing and new CMOs/CROs, including managing timelines and cost for the analytical development in support of manufacturing activities performed at CMOs
In collaboration with Quality Control, set product release and stability/shelf-life specifications
Support CMC assessment of in-licensing opportunities and technology opportunities.
Interact with global regulatory agencies and responsible for author and review of relevant sections of regulatory filings.

Requirements:

PhD or MS in chemistry, biochemistry, molecular biology, or chemical engineering with 10+ years of analytical development experience working in the Pharmaceutical or Biotechnology industry.
Hands on experience in analytical method development for biologics including HPLC, CE and mass spectrometry-based methods.
In-depth understanding of product characterization of biologics, including monoclonal antibodies and proteins
In-depth 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/BLAs/MAAs
Leadership and management experience of internal departments and contract manufacturing sites and contract analytical labs
Proven leadership experience and savvy influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team building, communication, and organizational skills required.

Physical Demands/Work Environment/Safety Considerations:

Stand for extended periods of time with periodic stooping/bending / kneeling.
Able to lift, push, pull up to 50lbs.
Climb ladders and stairs of various heights.
Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.
Certain tasks may require use of a respirator; medical clearance will be required in advance #LI-CS1 #LI-Hybrid

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$216,400—$267,300 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 · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * 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 talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.