Ultragenyx
Scientist II, Bioanalytical and Biomarker Operations
Ultragenyx, Novato, California, United States, 94949
Scientist II, Bioanalytical and Biomarker Operations
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.
Work Model Flex: Onsite work 2‑3 days per week (or as required by business needs).
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 best practices for laboratory operations.
Ensure compliance with FDA, EMA, GxP, and SOPs; participate in audits and inspections.
Develop and manage budgets for bioanalytical and biomarker operations; plan risk mitigation strategies.
Collaborate with cross‑functional teams; communicate progress and challenges to stakeholders.
Lead continuous improvement efforts to optimize processes, reduce turnaround times, and lower costs.
Identify opportunities for automation and innovative methodologies.
Requirements
PhD, MSc, BA/BS, or equivalent in a relevant scientific discipline (biochemistry, analytical chemistry, pharmacology, biology, etc.).
10+ years of experience in the pharmaceutical, biotech, or CRO industry supporting bioanalytical operations.
Three to five years of hands‑on LC‑MS method development and validation experience preferred.
Strong regulatory compliance experience (GLP, GxP, FDA, EMA).
Excellent project management, budgeting, and stakeholder communication skills.
Skills and Expertise
Hands‑on experience with LC‑MS, immunoassays, PCR (ASO or siRMA preferred).
Expertise in development, validation, and implementation of bioanalytical methods; knowledge of current regulatory guidelines.
Analytical, strategic, and problem‑solving skills.
Experience with vendor management, risk mitigation, and CRO oversight.
Clear communication and interpersonal skills.
Preferred Qualifications
Experience in early- and late‑phase clinical bioanalysis.
Familiarity with laboratory automation and innovative technologies.
Track record of successful regulatory submissions and inspections.
Knowledge of project management tools and best practices.
Salary Range $126,900 USD – $156,800 USD per year.
Benefits
Generous vacation time and public holidays.
Volunteer days.
Long‑term incentive and employee stock purchase plans.
Employee wellbeing benefits.
Fitness reimbursement.Tuition sponsorship.
Professional development plans.
Equal Opportunity Employer Ultragenyx Pharmaceutical is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, and veteran status. Reasonable accommodation will be provided for all protected statuses. Applicants can request accommodations before accepting a job offer.
To apply, email
talentacquisition@ultragenyx.com .
Note to External Recruiters:
All candidate activity is managed strictly through the Human Resources Department. Please do not contact employees or hiring managers directly.
#J-18808-Ljbffr
Work Model Flex: Onsite work 2‑3 days per week (or as required by business needs).
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 best practices for laboratory operations.
Ensure compliance with FDA, EMA, GxP, and SOPs; participate in audits and inspections.
Develop and manage budgets for bioanalytical and biomarker operations; plan risk mitigation strategies.
Collaborate with cross‑functional teams; communicate progress and challenges to stakeholders.
Lead continuous improvement efforts to optimize processes, reduce turnaround times, and lower costs.
Identify opportunities for automation and innovative methodologies.
Requirements
PhD, MSc, BA/BS, or equivalent in a relevant scientific discipline (biochemistry, analytical chemistry, pharmacology, biology, etc.).
10+ years of experience in the pharmaceutical, biotech, or CRO industry supporting bioanalytical operations.
Three to five years of hands‑on LC‑MS method development and validation experience preferred.
Strong regulatory compliance experience (GLP, GxP, FDA, EMA).
Excellent project management, budgeting, and stakeholder communication skills.
Skills and Expertise
Hands‑on experience with LC‑MS, immunoassays, PCR (ASO or siRMA preferred).
Expertise in development, validation, and implementation of bioanalytical methods; knowledge of current regulatory guidelines.
Analytical, strategic, and problem‑solving skills.
Experience with vendor management, risk mitigation, and CRO oversight.
Clear communication and interpersonal skills.
Preferred Qualifications
Experience in early- and late‑phase clinical bioanalysis.
Familiarity with laboratory automation and innovative technologies.
Track record of successful regulatory submissions and inspections.
Knowledge of project management tools and best practices.
Salary Range $126,900 USD – $156,800 USD per year.
Benefits
Generous vacation time and public holidays.
Volunteer days.
Long‑term incentive and employee stock purchase plans.
Employee wellbeing benefits.
Fitness reimbursement.Tuition sponsorship.
Professional development plans.
Equal Opportunity Employer Ultragenyx Pharmaceutical is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, and veteran status. Reasonable accommodation will be provided for all protected statuses. Applicants can request accommodations before accepting a job offer.
To apply, email
talentacquisition@ultragenyx.com .
Note to External Recruiters:
All candidate activity is managed strictly through the Human Resources Department. Please do not contact employees or hiring managers directly.
#J-18808-Ljbffr