Director, Analytical Development

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. You 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. #LI-CS1 #LI-Hybrid