Scientist II, Bioanalytical and Biomarker Operations

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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 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 andpersonally come join our team . Position Summary : 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. ultra impact Make a difference for those who need it most Work Model : Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite. Responsibilities : Bioanalytical and Biomarker Operations Management : 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 the Ultragenyx processes. Develop and / or support KPIs for operational excellence and manage / optimize as appropriate Regulatory Compliance and Quality Assurance : 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 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 Strategic Planning and Budgeting : 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. Contribute to department budget oversight and ensure deliverables are within timelines budget and fair market value Stakeholder Collaboration : Collaborate with cross-functional teams including internal laboratory BBD project reps Biomarker strategist clinical development regulatory affairs and project management etc. Ensure timely communication of progress challenges and solutions to key stakeholders project reams and senior leadership Continuous Improvement and Innovation : 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 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 Skills and Expertise : 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 Three to five years of hands-on LC-MS method development and validation experience preferred 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 Preferred Qualifications : 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 #LI-CT1 #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 applicants 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 $ - $ 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 . See our CCPA Employee and Applicant Privacy Notice . It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be a subject of criminal penalties and civil liability. Key Skills Laboratory Experience,Immunoassays,Machine Learning,Biochemistry,Assays,Research Experience,Spectroscopy,Research & Development,cGMP,Cell Culture,Molecular Biology,Data Analysis Skills Employment Type: Full Time Experience : years Vacancy : 1 Monthly Salary Salary : - #J-18808-Ljbffr