Scientist II, Bioanalytical and Biomarker Operations

Ultragenyx • Novato, CA

100d • $126,900 - $156,800

About The Position

Ultragenyx is seeking a motivated Scientist to join the Bioanalytical and Biomarker Development group. This role will oversee bioanalytical and biomarker assay development and sample testing at CROs, ensuring smooth method transfers, high-quality assay validation, and successful study execution. The Scientist will also manage budgets, ensure regulatory compliance, and collaborate with internal teams and CRO partners to drive operational excellence.

Requirements

• PhD, MSc, a BA/BS or equivalent in a relevant scientific discipline (e.g., biochemistry, analytical chemistry, pharmacology, or biology).
• Preferred 10 years of experience in the pharmaceutical, biotech, or contract research industry supporting bioanalytical operations.
• Scientist II: PhD with a minimum of 3-5 years related or post-doctoral experience; or a MS and a minimum of 8-10 years related experience; or a BA/BS and a minimum of 8-15 years related experience.
• Strong understanding and hands on experience of bioanalytical techniques (e.g., LC-MS, immunoassays, PCR) that support a multi-modality portfolio; prior experience on ASO or siRMA is preferred.
• Expertise in the development, validation, and implementation of bioanalytical methods; well-versed in current regulatory bioanalytical guidelines.
• Extensive experience in regulatory compliance (GLP, GxP, FDA, EMA) and quality assurance.
• Previous clinical study management experience is a plus.
• Proven ability to analyze complex data, provide strategic insights, and solve technical challenges.
• Strong expertise of the risk mitigation for vendor management activities, with a demonstrated track record in stakeholder management.
• Excellent CRO management, project management, budgeting, and resource allocation skills.
• Strong communication and interpersonal skills, with the ability to present to senior management and regulatory agencies.

Nice To Haves

• Experience in clinical bioanalysis, as well as bioanalytical and biomarker assay development across early- and late-phase drug development.
• Familiarity with laboratory automation and innovative technologies in bioanalytical testing.
• Track record of contributing to successful regulatory submissions and inspections/audits.
• Knowledge of project management tools, methodologies, and best practices.

Responsibilities

• Oversee and manage the execution of assigned bioanalytical and biomarker assays and testing to support preclinical and clinical development programs.
• Ensure the timely, efficient, and high-quality delivery of bioanalytical and biomarker data.
• Develop and implement best practices for laboratory operations, including assay transfer, development/qualification, validation, and sample analysis as per the Ultragenyx processes.
• Develop and/or support KPIs for operational excellence and manage/optimize as appropriate.
• Ensure bioanalytical and biomarker operations comply with all relevant regulatory guidelines (e.g., FDA, EMA, GxP).
• Oversee the adherence of Standard Operating Procedures (SOPs) for bioanalytical and biomarker methods and laboratory operations.
• In partnership with CQA or GLP/GCLP compliance, participate in audits and inspections, ensuring that all bioanalytical and biomarker activities are conducted according to industry standards.
• Develop and manage budgets for bioanalytical and biomarker operations (non-clinical, clinical studies) of assigned studies.
• Partner with cross functional groups to establish best practices for planning study conduct and other study related activities.
• Plan and execute risk mitigation strategies and communicate to relevant stakeholders.
• Collaborate with cross-functional teams, including internal laboratory, BBD project reps, Biomarker strategist, clinical development, regulatory affairs, and project management.
• Ensure timely communication of progress, challenges, and solutions to key stakeholders, project teams, and senior leadership.
• Lead efforts to optimize bioanalytical processes, improve turnaround times, and reduce costs.
• Implement and adhere to the process maps for efficiency and productivity.
• Identify opportunities for automation, technology integration, and innovative methodologies in bioanalytical and biomarker testing.
• Stay up to date on the latest trends, technologies, and regulatory changes in the bioanalytical and biomarker field and communicate to the key stakeholders.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree