Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

We are seeking a highly capable and proactive Senior Finance Manager, EMEA to join our rapidly growing team in the EMEA Region. This is a critical new headcount addition that will be instrumental in stabilizing core financial controls and supporting a region expected to continue to grow its topline and investment.

Reporting to the EMEA Finance Director, the Senior Finance Manager will take ownership of essential operational and compliance duties. This role is ideal for a detail-oriented, commercially astute finance professional ready to thrive in a complex, fast-paced environment characterized by significant growth, multiple markets, new product launches (including gene therapies), and evolving partner deals.

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.
Or
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Perform detailed, day-to-day Opex tracking, variance analysis, and reporting, supporting OPEX and cost savings/productivity initiatives through transparent reporting and targeted analytics
• Provide proactive budget holder support to Commercial and Medical teams, ensuring strict adherence to budgets and financial policies
• Manage and control transactional volume related to increased headcount, vendor management, and travel/expense reporting
• Generate monthly and quarterly performance reports and review with regional, country, and department managers
• Maintain controllership of expenses, with focus on all OpEx lines directly controlled by the European entities
• Deliver monthly and quarterly results reporting, including variance analysis and corrective action plans, and recommend cost-saving initiatives to achieve financial targets
• Work closely with US-based teams to support procure-to-pay, payroll, management/statutory reporting, IT, HR, and other corporate processes
• Drive process improvement projects with corporate and regional functions to deliver cost and operational efficiencies across the region
• Support monthly and quarterly financial close processes, including preparation of accruals and detailed revenue reconciliation across multiple brands, countries, and partner deals
• Lead improvements in FP&A reporting, forecasting, and automation to enhance reliability, efficiency, and insight generation
• Act as the primary liaison for Global Accounting, Supply Chain, and Tax, supporting compliance and minimizing operational risk across the region
• Identify and implement improvements in core financial processes and utilize data analytics (Power BI, Excel) to deliver insights, scenario planning, and support senior stakeholder decision-making

Requirements:

• Minimum 5+ years of progressive experience in Finance (FP&A, Controlling, or Corporate Finance), in the biotech, pharmaceutical, or life sciences sector in a European context
• Master’s degree in finance, Accounting, Economics, or relevant field; professional qualification (CFA, ACA, ACCA, CIMA or equivalent) highly desirable
• Fluent English required; additional European language (e.g., German, French) a strong asset
• Demonstrable understanding of biotech business drivers, including revenue recognition for complex licensing/partner deals and product launch dynamics
• Strong proficiency in Opex tracking, financial analysis, and budget management
• Solid understanding of revenue recognition principles within pharmaceutical or life sciences environments
• Advanced Microsoft tools skills, including Excel and Power Query, with experience using ERP/financial planning systems and Power BI
• High attention to detail with a strong focus on compliance and financial control
• Proven ability to work cross-functionally and act as a liaison with global teams while building strong relationships
• Ability to manage high volumes of transactional activity while maintaining data integrity, alongside strong personal effectiveness (resilience, accountability, and self-motivation)

#LI-CK1 #LI-Remote

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Reporting to the QC Microbiology Director, the Senior QC Analyst II will support the Ultragenyx gene therapy program pipeline through oversight, review and/or execution of GMP microbiological assays including but not limited to endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing.  This position is responsible for scheduling laboratory activities and ensuring testing is completed on time and in a compliant manner. 

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. SME for multiple microbiological assays (e.g. bioburden, endotoxin, TOC, conductivity, growth promotion, etc.). 
2. Execute routine, non-routine, and qualification testing of in-house microbiological methods. 
3. Review and approve cGMP analytical data from utility, release, and stability testing for internally and externally generated data. 
4. Support and lead QC Microbiology laboratory operations (e.g. monitor incoming samples, schedule microbial testing and qualification of critical media and reagents, ensure QC data packets and logbooks are reviewed within required timelines, etc.). 
5. Independently own and author quality records including change controls, deviations, CAPAs, invalid assays, excursion investigations, OOS Investigations, etc. with minimal managerial oversite. 
6. Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).  
7. Serve as trainer for in-house microbiological methods. 
8. Lead, or participate in, the development of new methods.  
9. Model leadership behaviors and mentor/train junior staff.   
10. Work with internal/external personnel within and outside area of expertise to support cross functional activities. 
11. Participate in regulatory inspections. 

Requirements:

1. BS or MS in Microbiology with 6+ years of QC experience. 
2. Demonstrated knowledge of microbiological methods including endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing. 
3. Strong technical writing skills with demonstrated experience in controlled document generation in accordance with GMPs. 
4. Experience with electronic document management systems (EDMS) such as Veeva Vault and LIMS is preferred. 
5. Strong collaboration and communication skills. 
6. Independently motivated and detail-oriented with good problem-solving ability. 

Physical Demand Requirements:

• 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-CT1 #LI-Onsite

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Medical Writing-Publications will provide strategic direction within the department and lead the successful development and tactical execution of publication plans across multiple programs in alignment with integrated evidence generation plans and lifecycle strategies and in compliance with SOPs, publication guidelines, and company goals. In addition, the Senior Director will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, including distribution of work to medical writers or agencies as needed. They will serve as the primary contact for publication activities in collaboration with a cross‐functional group, including Clinical Development, Medical Affairs, Biometrics, Pharm/Tox, Research, and other relevant functions.  

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.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Lead key strategic initiatives within the department including publication strategy, planning, and execution of Ultragenyx products and pipeline publication plans, ensuring alignment with department and company goals. 
2. Provide leadership within the department by proposing and overseeing new initiatives and capabilities, such as establishing best practices for pubs strategy development and pull-through. 
3. Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses and provide publication support and ensure compliant development of company-sponsored publications. 
4. Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions).  
5. Liaise with relevant corporate functions and partner(s), as applicable, to ensure appropriate communication of publications‐related activities including manuscripts and congress abstracts/posters/presentations. 
6. Uses advanced communication and persuasion strategies to negotiate on behalf of their department or function on strategic matters. 
7. Contributes to strategic planning for the broader function and support high‐quality execution of Corporate‐wide initiatives. 
8. Acts as a trusted advisor and recognized technical expert. 
9. Manage and/or mentor junior medical writers and contractors. 
10. Support publication budget planning and management. 

Requirements:

1. BS, MS, or doctorate in a scientific or medical field. 
2. Solid experience (BS with >15 years or advanced degree with >10 years) in publication management and medical writing in the biotechnology/pharmaceutical industry preferred. 
3. Proven success with leading and managing medical writing agencies as well as track record for consistently meeting or exceeding quantitative targets. 
4. Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of applicable publications-related guidelines (i.e., ICMJE, GPP) and best practices, as well as legal, regulatory, compliance, and clinical/medical affairs. 
5. Experience writing and preparing manuscripts for publication in peer‐reviewed journals as well as abstracts, posters, and slide decks for presentation at scientific congresses. 
6. Successful and superior influencing skills across all levels of the organization and external collaborators. 
7. Exceptional oral and written communication skills. 
8. Experience in successfully engaging with cross‐functional product teams. 
9. Strong organizational abilities and experience in a multitasking environment. 
10. Motivated, self‐directed, and able to work autonomously and in team settings to meet aggressive organizational goals. 
11. Rare disease experience and a strong understanding of neurodevelopmental disorders are a plus. 

#LI-CS1 #LI-Hybrid, or #LI-Remote

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Associate Director, GRA Global Labeling will be responsible for providing global labeling expertise and direction in support of the development, registration, and lifecycle management of innovative programs for rare diseases. This individual will liaise across key functional areas collecting critical regulatory milestones and developing detailed target label strategy plans during clinical development programs in order to align with company objectives and registration strategies. The responsibilities include managing labeling changes for lifecycle products, assisting in the development of labeling content for new products in pre-approval stages, and reviewing applicable regulatory documentation and artwork. The individual will also support implementation of approved labels which may include document control, QC/proofread, translations and verification of translations, and tracking project milestones and status. The individual must possess a thorough knowledge of global regulations and guidance governing drugs and biologics in all phases of clinical development. This position will report to Senior Director, GRA Global Labeling. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases. 

• Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources. 

• Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes). 

• Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text.  

• Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations. 

• Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors. 

• Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones). 

• Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness. 

• Contribute to the review and approval of artwork supporting global submissions. 

• Implement and maintain a quality control measure during all stages of label development. 

• Maintain knowledgebase of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s).   

• Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business. 

Requirements:

• Minimum BA/BS degree in life sciences. Advanced degree preferred. 

• Strong scientific background with 8 years’ experience in the biotechnology and/or pharmaceutical industry including at least 4+ years in a global regulatory/labeling position. 

• Excellent attention to detail with solid coordinating, task planning and time management skills. 

• Excellent verbal, written and interpersonal communication skills. 

• Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability. 

• Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making in a collaborative way, and implementing plans and risk mitigation strategies. 

• Thorough understanding of global drug development regulations and guidelines. 
• Willingness to work in a dynamic, fast paced and changing corporate environment where roles and responsibilities are not well defined. 

#LI-CS1 #LI-Remote

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Commercial Intern for Commercial Affairs provides comprehensive administrative support to the Commercial team and Office Manager, ensuring efficient operations and smooth workflow. This role requires excellent organizational, communication, and interpersonal skills, as well as the ability to handle confidential information with discretion. The ideal candidate will be proactive, detail-oriented, and capable of managing multiple tasks in a fast-paced environment.

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:

1. Calendar Management: Schedule and coordinate meetings, appointments, and travel arrangements for Medical Affairs team members, including both internal and external stakeholders.
2. Meeting Support: Prepare meeting agendas, take and distribute meeting minutes, and manage logistics for departmental meetings, conferences, and events. 
3. Internal and External Events Support: Manage logistics (venue, transportation, accommodation), contract drafting, and payment workflow 
4. Document Management: Maintain and organize departmental files, including electronic and hard copy documents, ensuring accuracy and accessibility. This includes managing contracts, presentations, and medical literature. 
5. Expense Reporting and Budget Support: Process expense reports, track departmental budgets, and assist with procurement and invoice processing. 
6. Communication and Correspondence: Manage incoming and outgoing correspondence, including emails, phone calls, and mail, and draft and edit documents, presentations, and reports.
7. Data Entry and Reporting: Enter and maintain data in various databases and systems and generate reports as needed. 
8. Travel Coordination: Arrange complex domestic and international travel, including flights, accommodations, and transportation, and prepare travel itineraries.  
9. Vendor Liaison: Communicate with vendors and external partners regarding contracts, invoices, and other administrative matters. 
10. Compliance Support: Assist with compliance-related activities, document tracking and archiving, and ensure adherence to company policies and procedures. 
11. Office Manager Support: Provide general administrative support, CONCUR, including ordering office supplies, managing office equipment, and handling incoming and outgoing mail. 

Requirements:

1. Education: Must currently be enrolled in a degree program; associate or bachelor’s degree preferred. 
2. Experience: Minimum of 01 year of administrative experience, preferably in a medical, pharmaceutical, or healthcare setting.  
3. Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), and experience with database management and electronic document management systems. 
4. Communication Skills: Excellent written and verbal communication skills, with the ability to interact professionally with individuals at all levels.  
5. Organizational Skills: Strong organizational and time-management skills, with the ability to prioritize tasks and meet deadlines.
6. Attention to Detail: Meticulous attention to detail and accuracy in all work.  
7. Confidentiality: Ability to handle sensitive and confidential information with discretion and professionalism.
8. Problem-Solving Skills: Ability to identify and resolve administrative issues effectively. 
9. Interpersonal Skills: Strong interpersonal skills and the ability to work effectively as part of a team.
10. Adaptability: Ability to adapt to changing priorities and work in a fast-paced environment.
11. Proficiencyin Spanish and English (written and verbal) is highly desirable

#LI-AJ1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Regional Supply Chain Management for Japan acts as the representative for Global Supply Chain Management for all matters relating to the Japan region. This position focusses on building, implementing and executing the regional supply planning and distribution strategy in alignment with overall regional business strategy. The role oversees the distribution network and operations, regional demand, supply, operations and inventory planning, as well as ensuring successful product in-market product launches. 

This highly matrixed role closely liaises with many global and regional functions (Sales & Commercial, Packaging, Supply Planning, Medical Affairs, Clinical Operations, Quality, Finance and Tax), and represents the global supply chain in all Japan regional matters. This position also ensures compliance of the supply operations with local / regional regulations and global standards. 

The role may also act as a liaison between the local Japan management team and the wider Technical Operations group in the Japan region – including Global Packaging Operations and Global Product Supply.   

This position is a member of the Global Supply Chain leadership team and is located in Tokyo, Japan.  

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:

1. As the Japan region grows, support all supply related activities in the region. Represent supply chain on the regional commercial management team.  
2. Build and oversee a reliable supply network in Japan for commercial distribution and support local clinical distribution activities including new product launch readiness as needed. 
3. Manage all local supply chain related activities including, but not limited to, order management, transportation, warehousing, inventory management and reporting, logistics and trade (import / export), and ERP transactions for Japanese product. 
4. Own the business relationship with all in country third party logistics providers. 
5. Alongside the local commercial team, oversee the regional Sales Inventory and Operations Planning (SIOP) for commercial launches, marketed products, early access programs and investigator sponsored trials. 
6. Develop annual budget plans and ensure supply chain costs in the region align with financial goals. Identify opportunities for supply chain related cost savings and implement solutions. 
7. Ensure compliance with regional regulations, GDP guidance, trade compliance and tax compliance in all areas of the regional supply chains 
8. Support for order processing operations from and to the wholesaler. 

Requirements:

1. Language: Fluency in both Japanese and English is required, both written and spoken, as well as understanding of local business norms in both countries. 
2. Education: A bachelor’s degree or local equivalent in a related field (Supply Chain, Business, Engineering). A master’s degree in business administration (MBA) is strongly preferred. 
3. Management experience: 8 or more years of experience in Supply Chain / Technical Operations in the pharmaceutical or biotech industries. Strong preference for project management and pharmaceutical launch experience as well as a certificate in Lean / Six-sigma training (green belt or higher). 
4. Pharmaceutical and regulatory experience: Understanding of pharmaceutical industry procedures and regulations including GxP and other regulatory requirements – particularly as it pertains to the local Japan market. Experience with new product introductions as it pertains to supply chain is preferred. 
5. Quality acumen: Familiarity with local and harmonized quality standards as they pertain to finished products and distribution. Experience operating in a pharmaceutical or biotechnology quality system and its related components (deviation, change control, etc…)    
6. Financial acumen and compliance: Understanding of regional and global commercial implications including SOX, tax regulations, international trade rules and trade compliance. 
7. Information technology: Hands on experience with the implementation and / or operation of a scalable enterprise resource system (ERP) such as Oracle, SAP or similar system. 
8. Travel: Ability and willingness to travel throughout Japan as needed as well as internationally (estimated four times per year), including travel to California. 

#LI-CK1  #LI-Hybrid

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Ultragenyx is seeking a dynamic and experienced physician to join the Gene Therapy Treatment Team. The physician will play a key medical affairs leadership role within the gene therapy portfolio, initially focused on GSDIa and MPS IIIA, where the company is in position to launch two gene therapies this year. This position will be instrumental in providing clinical and scientific education to gene therapy treating centers to ensure that patients receive their one-time therapy in the most effective manner and achieve their optimal therapeutic outcome.  

Reporting to the VP Global Medical Expert – Gene Therapies, the Executive Director is a senior medical affairs leader responsible for ensuring scientifically rigorous, compliant, and effective implementation of one-time gene therapies. The Executive Director will work closely with Medical Science Liaisons in the high-profile and innovative Gene Therapy Treatment Team through a largely externally facing role. The Executive Director also partners closely with Medical Affairs, Clinical Development, Regulatory, and Commercial leadership to enable successful launch and post launch adoption, while shaping external scientific dialogue around safety, durability, immunomodulation, and patient outcomes.   

The role requires extensive peer-to-peer interactions with external physicians providing gene therapy treatment in the commercial setting. The successful candidate will be comfortable working in a fast-paced intellectual environment, understand patient care including immunomodulation, and is able to work at the interface between clinical development and medical affairs leveraging their expertise to advance our mission to change the future of rare disease medicine. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Serve as a senior external medical leader for Ultragenyx gene therapies, leading compliant complex, scientific discussions with treating physicians  

• Enable successful implementation of gene therapies globally both within Ultragenyx and with external medical experts 

• Respond to inquiries and questions from treating sites with appropriate level of urgency 

• Lead the strategic and scientific requirements for educational materials and lead the delivery of training for the gene therapy treatment centers to ensure those centers are well prepared to manage patients throughout their gene therapy treatment journey 

• Provide expertise and contribute as needed to protocol development, steering committee meetings, data generation initiatives of Disease Monitoring Programs, and life-cycle management for label/indication expansion 

• Advise on strategic development of publications and medical materials that enable external medical engagement and address evidence gaps to inform clinical decision making 

• Work in partnership with VP, GME – Gene Therapies to develop and implement the global Gene Therapies Treatment Team Framework  

• Mentor and develop Global Medical Expert physicians and MSLs, helping build a scalable, high‑performing medical organization to support current and future gene therapy launches 

• Provide expertise and contribute as needed to key regulatory agency communications, including filings and information request responses 

• Represent Ultragenyx at key scientific and external stakeholder meetings to advance awareness and deep understanding of our science and therapies 

• As an expert, lead the education and training of Ultragenyx internal teams  

• Stay abreast of internal and external developments, trends and dynamics and provide direction for strategic implications to the development and commercialization of gene therapy  

Requirements:

• Medical Doctor (MD required, MD plus PhD preferred) with Board Certification (or equivalent) in Clinical Immunology, Clinical/Biochemical Genetics, Rheumatology or Neurology (required) 

• Academic/Faculty experience (+7 years) with a track record of high-quality publications   

• Pharmaceutical experience in drug development and clinical trials or Medical Affairs (+7 years) 

• Experience in the management of patients receiving systemic AAV gene therapy in the clinical trial and/or post FDA approval setting  

• Demonstrated ability to prioritize and lead complex post‑approval gene therapy activities, applying sound scientific judgment while enabling cross‑functional decision‑making 

• Demonstrated ability to lead through ambiguity and make strategic medical decisions in first‑ or best‑in‑class therapeutic settings 

• Availability for some out-of-hours work is an expectation 

• Demonstrated success working in a cross functional or multidisciplinary setting is essential 

• An established broad network of key experts and leaders within the rare disease community  
• Travel: 25-50% but may reduce with time as launches progress and team grows   

#LI-CS1 #LI-Remote

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

The GMP Facilities Tech II performs preventative and corrective maintenance on a variety of complex utility systems within Ultragenyx GMP QC laboratory and manufacturing facilities. Equipment/systems include but is not limited to HVAC systems, cold storage, compressed air and gas systems, Reverse Osmosis (RO) and Water for Injection (WFI) systems, wastewater treatment, clean steam generation, fire detection/suppression, boilers, pumps/motors, etc. The Facilities Tech II will also perform corrective and preventive maintenance on GMP lab instruments and process equipment such as bioreactors, filling machines, centrifuges, rockers, chromatography columns, autoclaves, and glass washers. With minimal oversight, the Facilities Tech II must be able to interpret drawings, wiring diagrams, and equipment specifications to effectively perform troubleshooting and repair activities.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols. This is a 12 hour shift based position.  Hours will be 12 midnight to 10 am typically Wednesday through Saturday, but days could vary depending on coverage needed.

Responsibilities:

1. Perform and document all corrective and preventative maintenance activities performed on GMP facility equipment and/or systems in accordance with GDP requirements.

2. Ensure GMP compliance with all facilities related activities including corrective and preventative maintenance.

3. Troubleshoot complex electrical and controls issues on all building systems and equipment.

4. Maintain all facility equipment and systems at optimum levels of performance, efficiency, and reliability.

5. Ensure that all facilities and maintenance activities are performed in accordance with current internal and external requirements for safety, quality, regulatory environmental, and compliance standards.

6. Execute continuous improvement projects to improve departmental performance.

7. Collaboratively work to resolve issues and improve equipment performance.

8. Always demonstrate good safety practices, including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.

9. Respond to emergency service calls and resolve identified issues in a timely manner and in accordance with all safety, quality and compliance requirements.

10. Perform weekend walkthrough duties according to schedule.

11. Participate in an On-Call rotation for off hour facility emergencies.

12. Ensure that all required quality and safety training is completed on time and current.

Requirements:

Minimum of a High School Diploma, preferably a college degree, or equivalent combination of education and direct work experience

1. 3+ years of experience working in a GMP or regulated environment required.

2. Experience working for a maintenance organization in a GMP Biotech/Pharmaceutical manufacturing environment is preferred.

3. Experience with Building Management Systems (BMS) and Computerized Maintenance Monitoring System (CMMS) software is preferred.

4. Licensure in any of the following areas is preferred: Wastewater Treatment, Refrigeration/Air Conditioning, Electrician, or Plumbing.

5. Must demonstrate ability to work independently, make effective decisions, resolve technical issues, and manage time effectively.

6. Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization across all departments.

7. Must demonstrate the ability to work effectively in teams to achieve results.

8. Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is required.

Physical Demand Requirements: 

· Stand for extended periods of time with periodic stooping / bending / kneeling.

· Ability to climb ladders and stairs of various heights.

· Able to lift, push, pull up to 50lbs.

· Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.

· Certain tasks may require use of a respirator; medical clearance will be required in advance.

· Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment.

· Working in temperature-controlled environments (cold rooms).

#LI-CT1 #LI-Onsite

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

The primary role of the EHS intern is to support EHS compliance activities related to the Gene Therapy Manufacturing Facility located in Bedford, MA and Quality Control Labs located in Woburn, MA.  This includes supporting EHS functions within manufacturing, facilities, engineering, warehouse, laboratories, and office spaces.  This role will support site inspections, data management, metric reporting, and continuous improvement projects. In addition, this assignment will offer the opportunity to learn about gene therapy manufacturing and hands-on experience supporting manufacturing process systems in a GMP environment and Quality Control laboratories.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Draft, deliver and support EHS department communications (safety alerts, events, training).
• Assist with EHS Insight data management including incident investigations, hazard reporting, inspections, corrective actions, and compliance tasks.
• Assist in coordination and execution of Emergency Response activities (evacuation, medical, spill response, business continuity).
• Assist with contractor management oversight, including developing Job Hazard Analysis and safe work permits.
• Collaborate with key stakeholders (Facilities, Quality Control) regarding inspection findings and corrective action planning.
• Support a fast-paced work environment with many tasks and shifting priorities.

Requirements:

• BS/BA in technical discipline: Safety, Environmental, Life Sciences, Engineering or similar field.
• 0-1 year experience in the EHS field, prior internship is desired.
• Strong communication and organization skills. Creative problem-solving capabilities

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 controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Certain tasks may require the use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).

U.S. Hourly Wage Range: 

• $23.00-$30.00/hour
• The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s experience/educational background.

#LI-AJ1

Position Summary:

ultraimpact – Make a difference for those who need it most

Are you a motivated self-starter looking to jumpstart your career in a professional, regulated environment? We are looking for a Maintenance Coordinator to join our team at the Bedford facility. This is a critical support role for our maintenance team. If you are someone who loves to stay organized, enjoys helping others succeed, and has a high level of personal integrity, we want to invest in your growth.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

In this role, you will be the "nerve center" for our maintenance department, ensuring that every bolt turned and inspection completed is documented correctly. Your main tasks will include:

• CMMS Management: Accurate recording and documentation of the team’s daily maintenance activities in our Computerized Maintenance Management System.
• Vendor Liaison: Tracking sub-contractor and vendor documentation. You will proactively reach out to suppliers to ensure all paperwork is submitted accurately and on time.
• Operational Support: Identifying ways to "clear the path" for our technicians so they can focus on their technical work.
• Compliance & Integrity: Maintaining precise records that meet our strict regulatory standards. Doing the job right—even when no one is looking—is our top priority.

Requirements:

• Eager to Learn: You have a H.S. Diploma or equivalent and a genuine desire to develop professional skills in a technical industry.
• A Self-Starter: You don’t wait to be told what to do next. You see a gap and you fill it.
• Detail-Oriented: You understand that in a regulated environment, the job isn't finished until the paperwork is perfect.
• Communicator: You are comfortable picking up the phone to follow up with vendors and can communicate clearly with the internal team.
• • This internship is a full-time (40 hours per week) and reporting on site, 5 days a week to 170 Middlesex Turnpike, Bedford, MA and will start in May 2026 for one year. 
  • Ideal candidates will be high school graduates, participants or recent graduates of a biotechnology certificate program or those working on an associates degree.

U.S. Hourly Wage Range:

• $23.00-$25.00 
• The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Reporting to the Medical Affairs Director. The Intern, Medical Affairs is responsible for supporting the local medical affairs activities for the Ultragenyx portfolio of products and assist in the management of medical affairs operations in the country. The candidate will be working in conjunction with the local Medical Affairs team, Commercial team, Commercial and Market Access and Government Affairs Director and Sr. Product manager. This role will best suit someone who wants to learn about rare diseases business, provide creative ideas and gain experience while earning their degree.   

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:

• Support planning and execution of Medical Plan, tactics and activities in country  

• Support Medical team to ensure develop and adequate tracking the activities to maximize our opportunities to gain in each key account (v.g. Forms on time, letters to Key Decision Makers (KDMs), coordinate strategic agenda between KDMs and Vendors, events planning, contracts and execution)  

• Support preparation and follow up of KPIs for Medical  

• Contact and follow up on the negotiations with the main medical societies together with medical affairs. 

• Contact with local communication agencies and/or travel agencies to support the medical events or development of promotional materials 

• Development of medical projects / plans under medical affairs supervision  

• Data analysis  

• Prepare reports and presentations based on company needs 

• Support the team in daily administrative tasks. 

Requirements:

• Student of Business Administration, Marketing or Social Communication 

• Excellent communication skills and teamwork  

• Ability to quickly learn and process information 

• Organization and time management skills 

• Fluency in English 

• Excellent knowledge of MS Office 

• The position will be based in CDMX, México

#LI-AJ1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

メディカルサイエンスリエゾン（Medical Science Liaison：MSL）は、メディカルディレクターおよびフィールドメディカルチームと緊密に連携し、日本国内におけるメディカル戦略の実行を担います。 
Key Opinion Leader（KOL）や主要医療機関へのサイエンスベースの関係構築、最新科学情報の提供、エンゲージメントを通じ、Ultragenyxの開発品および上市製品の医療的価値の最大化を支援します。 
科学的中立性を保ちながら情報交換を行い、国内の医療従事者に対し臨床・科学的サポートを提供するフィールドベースの専門職です。 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. メディカルディレクターと連携し、日本のフィールドメディカルプランを実行する。 
2. リージョナルメディカルプランに沿ったメディカル施策（タクティクス）を実行する。 
3. 医療現場からの重要なインサイトを収集し、日本のメディカルプランに沿って社内ステークホルダーへ適時共有する。 
4. Key Opinion Leader（KOL）の特定を支援し、主要施設との科学的関係を確立・維持する。 
5. KOLおよび医療従事者に対し、最新の科学的知見や疾患マネジメント情報を提供する。 
6. KOLを対象に、講演者・アドボケートの育成およびサポートを行う。 
7. アドバイザリーボードの企画・準備・運営をサポートし、学会ではポスター・口演のレビューなど科学的支援を提供する。 
8. すべての活動において、企業方針・SOP・コンプライアンスを遵守し、公正かつ透明性のあるメディカル活動を実施する。 

Requirements:

1. 医学・薬学・生命科学領域の高等学位（MD、PhD、PharmDなど）を有し、MSLなどフィールドメディカル業務で2年以上の経験があることが望ましい。 
2. 希少疾患領域、特に遺伝性疾患領域での経験があれば尚可。 
3. 英語の中級レベルのコミュニケーション能力、および日本語のネイティブレベルの読解・文章作成能力を有すること。 
4. 社内外のステークホルダーとの良好な関係構築に必要な高いコミュニケーション能力とチームワークスキルを有すること。 
5. 臨床・科学情報を効果的にプレゼンテーションできる能力を有すること。 
6. 日本の医療提供体制について深い理解を持ち、患者ケアや医療提供体制への影響を考慮した判断ができること。 
7. 自身の業務スケジュールを整理・優先順位付けできる能力を有し、テリトリー管理や時間管理のスキルを備えていること。 
8. 約30％の出張および必要に応じた宿泊を伴う出張に対応できること。

#LI-CK1 #LI-Remote

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

As a Medical Science Liaison (MSL) in Japan, you will work closely with Medical Directors and the field medical team to execute local medical strategies. 
You will develop and enhance scientific relationships with Key Opinion Leaders (KOLs) and key medical institutions, while supporting scientific exchange and providing fair balanced medical information. 
This field-based role requires strong scientific credibility to engage with thought leaders and centers of excellence, supporting Ultragenyx's development stage and commercial products in Japan. 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Execute the Japan Field Medical Plan in collaboration with Medical Directors. 
2. Implement medical tactics aligned with the regional medical plan. 
3. Collect key scientific and clinical insights and share them internally in alignment with the regional medical plan. 
4. Support identification of Key Opinion Leaders (KOLs) and build/maintain scientific relationships with academic and community centers. 
5. Disseminate cutting edge scientific information and disease management concepts to KOLs and other healthcare professionals. 
6. Develop and support KOL speakers and scientific advocates. 
7. Support planning and execution of advisory boards and providing scientific support at medical congresses, including poster and presentation reviews. 
8. Ensure all activities are compliant with company policies, SOPs, and relevant compliance standards. 

Requirements:

1. Advanced degree in clinical/healthcare disciplines (MD, PhD, PharmD) required;
2.  2+ years of field medical experience (e.g., MSL) strongly preferred. 
3. Rare disease experience, particularly in genetic disorders, is preferred. 
4. Intermediate English proficiency and native level Japanese reading and writing skills required. 
5. Strong teamwork and communication skills to build effective relationships with internal and external stakeholders. 
6. Demonstrated ability to effectively present clinical and scientific information. 
7. Expert understanding of the Japanese healthcare delivery system and its impact on patient and medical care. 
8. Ability to organize and prioritize workload, with strong territory and time management skills. 
9. Ability to travel approximately 30%, including overnight travel as needed. 

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyx’s small molecule and oligonucleotide programs. This role is responsible for execution of departmental manufacturing strategies, management of external CMOs, and delivery of reliable clinical and commercial supply under cGMP conditions. The Director partners cross‑functionally to ensure safe, compliant, and efficient manufacturing while operating within established functional strategies. 

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:

1. Lead and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment, supporting both clinical and commercial supply. 
2. Oversee production planning, execution, and performance tracking to ensure reliable fulfillment of agreed manufacturing services. 
3. Manage and strengthen CMO relationships, including selection, onboarding, governance, and ongoing performance management. 
4. Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio, ensuring alignment with development and supply strategies. 
5. Author and/or provide expert input into CMC sections for global regulatory filings, including INDs, IMPDs, NDAs, and MAAs. 
6. Serve as an integral member of cross‑functional and cross‑discipline CMC teams for programs containing synthetic components. 
7. Oversee process development, optimization, technology transfer, and lifecycle management, including change controls, deviations, and investigations. 
8. Ensure development and maintenance of manufacturing-related documentation, including Design History Files and Quality Risk Management Plans. 
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing and quality governance documents. 
10. Promote continuous improvement, knowledge management, and operational excellence while representing Drug Substance Manufacturing on global and cross‑functional teams. 

Requirements:

1. Ph.D. in chemistry, chemical engineering, organic chemistry, or a related discipline, or equivalent industry experience. 
2. 8–12 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing. 
3. Demonstrated experience in managing small molecule synthetic chemistry, pharmaceutical CMC development, process scale‑up, and cGMP manufacturing. 
4. Demonstrated experience managing and participating in cross‑functional CMC teams. 
5. Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus. 
6. Familiarity with QbD principles, DoE, process scale-up and optimization, validation/qualification, and phase‑appropriate controls. 
7. Solid knowledge of cGMP requirements, ICH guidelines, and phase‑appropriate controls.. 
8. Familiarity with analytical development and quality control is advantageous. 
9. Strong track record of building and sustaining effective CMO partnerships. 
10. Demonstrated ability to lead teams, manage complexity, and deliver results in a matrixed environment. 
11. Excellent written and verbal communication skills in English; additional languages are a plus. 
12. Demonstrated commitment to leadership development, coaching, and continuous learning. 

Physical Demand Requirements

Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment.  

#LI-CT1 #LI-Hybrid

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The role supports the LATAM Commercial Analytics team through data management, reporting, dashboard maintenance, and content organization, contributing to data-driven decision-making across the region. 

By transforming market and commercial data into actionable business insights, this role is also responsible for developing tools and sales force effectiveness analysis that support the commercial & medical teams in executing, tracking, and optimizing tactical initiatives. 

In addition, Sr Analyst, Commercial Operations – LATAM serves as the focal point for the Veeva CRM system, ensuring data quality, system usability, training and alignment across all countries. 

This position provides exposure to the pharmaceutical industry, analytics tools, CRM systems, and cross-functional collaboration across the LATAM region. The role also plays a key support function to the Sr. Specialist, Commercial Operations LATAM in building, structuring, and continuously improving reports and presentations, offering strong hands-on learning opportunities while contributing to strategic regional initiatives. 

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:

• Work in partnership with LATAM commercial, medical and marketing teams to understand needs and translate into analytical reports/dashboards. 

• Develop, update and maintain automated reports/dashboards (PowerBI/Excel) to monitor business performance and improve effectiveness  

• Support the preparation of reports, KPIs, and presentations for LATAM monthly/quarterly business meetings. 

• Assist in collecting, cleaning, and organizing data from CRM, sales, and other internal sources and transform them into strategic business reports/dashboards 

• Support cross-functional data requests from LATAM & country Marketing, Commercial, Medical, Finance, and Supply Chain teams. 

• Point of contact for field teams regarding business performance and Veeva CRM questions. 

• Ensure Veeva CRM is consistently used across field teams in the region 

• Conduct Veeva CRM training session to accelerate end user adoption in LATAM 

• Maintain Veeva CRM data accuracy by performing basic validations and updates. 

• Lead Veeva CRM data update as well as system improvements requests 

• Support the documentation of analytics processes and improvements. 

• Assist contract uploading and approval process. 

• Support PO, invoicing and account payable tracking. 

Requirements:

• 3+ Years of experience working with Business Analytics, Market Intelligence, Sales force effectiveness, preferably in a pharmaceutical company 

• Bachelor’s degree in business, Engineering, Economics, Marketing, Data Science, or a related field. 

• Solid knowledge of Excel (formulas, charts, pivot tables) and Power BI is mandatory 

• Proved experience with CRM systems (Veeva/Salesforce).  

• Good organization skills and attention to detail. 

• Strong communication skills and willingness to work collaboratively. 

• Advanced English & Intermediate Spanish is required 

#LI-CK1 #LI-Hybrid

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

The Director of Disease Monitoring Programs (DMPs) is a visible leadership role accountable for the strategic planning and oversight for one or more assigned DMPs.  DMPs are a novel approach to GCP-compliant long-term data collection for rare diseases from pre-approval through post marketing. The Director of DMPs will collaborate with other functional leaders at both tactical and strategic levels.   

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups 
2. Ensure evidence strategy alignment throughout the development cycle for a program and across functions 
3. Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health) 
4. Provide input on the development of protocols, goals and endpoints tables, case report forms, Integrated Evidence Plans, publications, Steering Committees and other relevant deliverables 
5. Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc. 
6. Train and mentor cross-functional personnel working on DMPs as needed 

Requirements:

1. Bachelor degree or equivalent required (scientific or healthcare discipline preferred) 
2. 10+ years of progressively challenging experience in clinical research and/or drug development 
3. Critical thinking skills coupled with innovative approaches to problem solving 
4. Comfortable managing and presenting to senior level stakeholders 
5. Comprehensive understanding of high-quality data generation appropriate for regulatory, scientific, payer, physician and patient requirements to advance the understanding of rare diseases and their treatment/management  
6. Ability to provide operational expertise to a clinical development program 
7. Working knowledge of regulatory agency regulations and ICH GCP guidelines is required 
8. Strong strategic planning and decision-making skills 
9. Excellent written and verbal skills required.  Must display strong analytical and problem solving skills   
10. Willing and able to travel domestically and internationally 
11. Rare disease clinical trial experience desired 

#LI-CS1 #LI-Remote

Position Summary:

ultraimpact – Make a difference for those who need it most

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

We are seeking a motivated undergraduate/graduate student to join our AAV Purification Process Development team. The successful candidate will support laboratory and data‑driven activities that directly contribute to commercial manufacturing, process development, and clinical compatibility studies. This position offers hands‑on experience in gene therapy purification process development, exposure to GMP‑aligned development workflows, and the opportunity to learn industry‑relevant skills in various purification unit operations, clinical device compatibility, and industry relevant data analysis

• Actively contributes to programs in late-stage development to enhance AAV manufacturing technologies/capabilities and work-processes.
• Collect controlled experimental data and maintain accurate daily logs of experiments including methods, results, and conclusions.
• Conduct laboratory studies to support commercial manufacturing needs, including column and resin lifetime extension studies.
• Support development activities for AAV downstream processes, including buffer screening, filtration studies, and chromatography evaluations.
• Contribute to clinical in‑use compatibility studies, supporting material preparation, sample handling, and execution of defined protocols (as needed).
• Prepare buffers and solutions according to established procedures to support ongoing experiments and team operations.
• Support data management by compiling, organizing, and formatting process data
• Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports.
• Present scientific findings to the downstream and formulation development group or broader internal audience.
• Assist in general laboratory maintenance duties, including inventory of consumables and raw materials, buffer preparation, and routine lab maintenance/cleaning tasks.

Requirements:

• Graduate or Undergraduate student in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline.
• This is a 6 month co-op, starting July 6, 2026 working full-time (40 hours per week) until December 18, 2026
• Strong interest in bioprocessing, AAV/gene therapy, or downstream purification.
• Experience working with chromatography and filtration systems is a plus.
• Interest in learning and working in a fast-paced environment.
• Ability to follow protocols carefully and maintain attention to detail.
• Demonstrates strong organizational and communication skills and the ability to work effectively in a collaborative team environment.
• Independently motivated and detail-oriented with good problem-solving ability.

U.S. Hourly Wage Range: 

• $23.00-$30.00/hour. The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level.

#LI-AJ1     #LI-Onsite

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Director, FP&A will be a key business partner to Ultragenyx’s Development organization, with primary responsibility for strengthening financial governance, budget transparency, and accrual rigor across development activities. The position supports the Chief Medical Officer and senior Development leadership by enabling a clear, consistent understanding of spend to date, remaining budget, and forward‑looking financial exposure across clinical and non‑clinical functions. The role combines hands‑on analytical execution with executive‑level financial storytelling to improve confidence, decision‑making, and stewardship across the development portfolio. 

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:

1. Establish and maintain strong working relationships with Development leadership and operational stakeholders, serving as a trusted finance partner embedded in clinical study governance, financial oversight, and execution forums.  
2. Provide hands‑on financial support to Program Teams and Development functions by reviewing invoices, tracking actual spend, and identifying total and remaining budget at the study, program, and functional levels.  
3. Lead clinical trial cost modeling, including scenario planning and sensitivity analyses, clearly explaining cost drivers related to study design, timelines, enrollment assumptions, and execution strategies.  
4. Perform regular budget‑to‑actual analyses across clinical and non‑clinical Development activities, synthesizing account‑level, vendor‑level, and study‑level variances into concise, decision‑oriented insights.  
5. Deliver clear, actionable financial updates on spend, forecast changes, risks, and opportunities to minimize surprises and strengthen confidence in Development financial outlooks.  
6. Partner with Accounting and operational teams to support Development accrual processes, ensuring assumptions are timely, well‑documented, and aligned with underlying operational activity.  
7. Lead financial communications related to clinical trials and broader Development spend, including inputs to executive‑level readouts, portfolio reviews, and CMO‑level presentations.  
8. Support annual planning and in‑year reforecasting cycles by reviewing business‑generated forecasts, assessing reasonableness, and providing Development‑wide financial context and challenge.  
9. Design, implement, and continuously improve financial tools, reporting, and processes that enhance budget visibility, accrual understanding, and financial fluency across Development teams.  
10. Balance near‑term execution and stewardship of existing processes with a longer‑term focus on strengthening governance frameworks, standardization, and transparency across Development financial management. 

Requirements:

1. Bachelor’s degree in finance, Accounting, Economics, or a related discipline; MBA, CPA, or advanced degree preferred.  
2. Minimum of 12 years of progressive experience in FP&A, finance, or financial management supporting R&D or development organizations within the biotechnology, pharmaceutical, or life sciences industry.  
3. Demonstrated experience partnering with Development teams, including Clinical Operations and non‑clinical functions such as Regulatory, Pharmacovigilance, Biostatistics, and Statistical Programming.  
4. Deep expertise in clinical trial financial modeling, including cost drivers, scenario planning, and sensitivity analysis, with the ability to translate operational assumptions into credible forecasts.  
5. Strong background in financial governance, including budget oversight, variance analysis, accrual support, and spend‑to‑date transparency.  
6. Proven ability to influence without formal authority and partner effectively with senior leaders, program teams, and functional stakeholders.  
7. Ability to operate seamlessly between strategic and detailed perspectives, including hands‑on engagement with invoices, actuals, and accrual drivers, as well as executive‑level synthesis.  
8. Demonstrated success leading process improvement initiatives that improve budget visibility, accrual rigor, and financial fluency within business teams.  
9. Strong communication skills, with the ability to deliver clear, concise summaries of variances, forecast changes, and drivers to audiences ranging from study teams to executives.  
10. Advanced proficiency in financial modeling, forecasting, and analytics tools (e.g., Excel, Adaptive Insights, and enterprise planning systems) 

#LI-CK1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking an experienced Senior Director, Supply Chain Quality to provide global quality leadership and oversight across packaging, labeling, global logistics, distribution, and external supply chain partners supporting both clinical and commercial products. 

This role is accountable for establishing and maintaining a robust global Good Distribution Practice (GDP) quality framework that ensures compliant, reliable, and patient centric delivery of biologics, small molecule, antisense oligonucleotide (ASO), and gene therapy products. The successful candidate will bring deep hands-on experience with global GDP requirements, temperature controlled supply chains, and complex international distribution networks, and will serve as the quality authority for supply chain operations across internal teams and external partners. 

As a senior quality leader, this role will shape strategy, build organizational capability, and drive continuous improvement across the supply chain while ensuring inspection readiness and regulatory compliance globally. 

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:

• Provide global quality leadership and oversight for supply chain, packaging, labeling, warehousing, transportation, and distribution activities supporting clinical and commercial products.  

• Establish, implement, and maintain a robust global Good Distribution Practice (GDP) quality strategy, ensuring compliance with FDA, EMA, MHRA, WHO, PIC/S, and other applicable global regulations.  

• Serve as the Quality subject matter expert for complex global distribution models, including cold chain, ultra-cold chain, and controlled ambient logistics.  

• Provide QA oversight of packaging and labeling operations, including artwork approval, labeling controls, serialization/traceability, tamper-evident systems, and country-specific labeling requirements.  

• Lead qualification, oversight, and performance monitoring of external supply chain partners, including CMOs, 3PLs, freight forwarders, depots, and packaging vendors.  

• Ensure quality agreements clearly define GDP responsibilities, escalation pathways, compliance expectations, and performance metrics for all external partners.  

• Integrate GDP processes into the Quality Management System (QMS), including deviations, CAPAs, change control, complaints, risk management, and management review.  

• Lead and oversee investigations related to temperature excursions, shipment deviations, labeling errors, and distribution complaints, ensuring effective root cause analysis and sustainable corrective and preventive actions.  

• Serve as the quality representative for regulatory inspections and audits related to supply chain, distribution, packaging, and labeling, and support Health Authority and Qualified Person (QP) interactions.  

• Partner cross-functionally with Supply Chain, Technical Operations, Regulatory Affairs, Clinical Operations, and Commercial teams to support distribution network design, launch readiness, lifecycle management, and continuous improvement, while fostering a strong culture of quality and compliance. 

Requirements:

• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.  

• 15+ years of Quality Assurance experience in the biopharmaceutical industry, with substantial leadership responsibility in supply chain quality and GDP.  

• Demonstrated hands-on expertise in global GDP requirements, including EU GDP, U.S. distribution expectations, and international regulatory standards.  

• Proven experience supporting clinical and commercial distribution of temperature-sensitive products across global markets.  

• Experience working with biologics, small molecules, and advanced therapies (gene therapy and/or cell therapy experience strongly preferred).  

• Strong track record of leading and supporting regulatory inspections and audits (e.g., FDA, EMA, MHRA) related to supply chain and distribution.  

• Deep understanding of cGMP, GDP, and global regulatory expectations across U.S. and ex-U.S. regions.  

• Demonstrated ability to effectively manage and influence external partners, including CMOs, 3PLs, and logistics service providers.  

• Proven senior leadership presence with the ability to influence without direct authority in a matrixed, fast-paced environment.  
• Willingness and ability to travel approximately 15–20%, including domestic and international travel, as required. 

Physical Demand Requirements: 

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Working in temperature-controlled environments (cold rooms)  

#LI-CS1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyx’s drug product formulations, including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities, supports reliable clinical and commercial supply, and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partners cross‑functionally across Quality, Regulatory, Supply Chain, and Development organizations. 

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:

1. Lead external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment. 
2. Oversee production planning, execution, and performance tracking to ensure clinical and commercial supply commitments are met. 
3. Manage CMO relationships, including selection, onboarding, and performance management, fostering strong collaborative partnerships. 
4. Lead or support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs). 
5. Serve as an integral member of cross‑functional CMC teams, partnering with Quality, Regulatory, Supply Chain, Development, and Clinical teams. 
6. Develop and maintain manufacturing documentation, including Product Design History Files and Quality Risk Management Plans. 
7. Oversee process development, technology transfer, process optimization, and lifecycle management activities. 
8. Manage manufacturing-related deviations, change controls, investigations, and complaint responses. 
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents. 
10. Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on global and cross‑functional teams. 

Requirements:

1. PhD or equivalent relevant experience in Pharmaceutical Sciences, Engineering, or related discipline. 
2. 10–15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, preferably within global organizations. 
3. Demonstrated expertise in small molecule drug product development and clinical/commercial manufacturing; experience with multiple dosage forms preferred. 
4. Strong knowledge of QbD, DoE, process validation/qualification, phase‑appropriate manufacturing controls, PAT, and current regulatory expectations for drug products. 
5. Working knowledge of cGMP, ICH guidelines, and global regulatory submission requirements. 
6. Proven track record managing and sustaining effective CMO partnerships in a matrixed organization. 
7. Experience with analytical development and quality control is a plus. 
8. Strong problem‑solving, leadership, communication, and financial acumen. 
9. Commitment to coaching, feedback, and continuous learning and development.  

Physical Demand Requirements   

Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment.  

#LI-CT1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager, CMC QA will be responsible for the Product Complaints, Annual Product Quality Review and CMC Change Control Review Board programs and will maintain strategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyx’s CMC quality approach for the company. This role will direct and oversee operations in accordance with GxP regulations and Ultragenyx standards. 

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:

1. Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC 
2. Lead UGX Change Control Review Board program and provide coaching to Change Owners on the Change Control process as needed 
3. Support the release of production lots in accordance with Ultragenyx procedures 
4. Execution of Quality Systems in an Owner/SME or QA role, for Deviations, Change Controls and Product Quality Complaints 
5. Lead and actively participate in Continuous Improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners 
6. Design, develop, and review CMC QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department 
7. Support the Product Complaints function in investigating reported product quality events, as needed 
8. Represent Ultragenyx to Health Authorities during inspections 
9. Ensure activities and deliverables comply with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices. 
10. Communicate and promote a culture of quality and operational excellence  
11. Other duties as assigned 

Requirements:

1. A Bachelor’s degree or equivalent work experience in QA Manufacturing Operations or related discipline.  
2. 8+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality. 
3. Experience with management of Change Control process and Review Board. 
4. Experience with Product Disposition.  
5. Demonstrate quality mindset and influences across the entire organization. 
6. Strong understanding unique quality and manufacturing expectations from other regulatory authorities such as EMA, ANVISA, MHRA, etc. 
7. Expert knowledge of GMPs. 
8. Flexibility and the ability to manage change. 
9. Strong interpersonal skills and the ability to work well as part of a team. 
10. Demonstrated ability for analytical and systematic thinking. 
11. Experience with Product Complaint handling, investigations, and reporting a plus. 
12. Fosters an environment of accountability, diversity and speaking up. 
13. Demonstrated high personal and professional ethical standards. 
14. Travel up to 10% of total work hours.  

#LI-CT1 #LI-Hybrid

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Associate Director, Business Operations Northern Cluster will be responsible for driving the efficient execution of business operations, ensuring alignment between commercial, medical and other operational functions. The individual will work closely with the VP GM to define strategic priorities, improve processes and oversee day-to-day business activities in a fast paced, dynamic biotech organization that covers the following cluster of countries: UK, Ireland, Sweden, Norway, Denmark and Finland. This person should have experience with sales & marketing, financial, supply chain and operational processes. In addition, the ideal candidate should have experience establishing legal business entities and launching gene therapy products.  

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:

1. Operational effectiveness: Identify efficiencies and implement local solutions to improve productivity and scalability in the cluster. 
2. Strategic and tactical planning: Support the VP GM in collaborating with all functions to prepare and execute brand plans, new product launch plans, launch readiness metrics & dashboards, quarterly business reviews and long-range planning. Ensure pull-through of identified EMEA initiatives to local markets. 
3. Go-to-Market Gene Therapy Operations: Collaborate with the EMEA Gene Therapy launch team(s) to prepare and optimize local (site) readiness for gene therapy launches.  
4. Supply Chain Optimization: Partner with supply chain to enhance and develop product distribution in all markets. Lead and mange Home Delivery and Infusion services. 
5. Project Management: Oversee key projects, in particular affiliate legal entity set-up in prioritized countries, ensuring timelines, budgets and deliverables are met. Manage project budgets and third-party vendors to ensure optimal resource use. 
6. Cross-functional Cluster leadership and governance support: Support the VP GM in driving agenda preparation, slide preparation and leadership of key strategic operational meetings, offsites and forums.  
7. Compliance & Risk Management: Ensure adherence to local regulations e.g. ABPI, LIF etc. and mitigating operational risks 
8. Analytics and Insights generation: collaborating with the Regional Analytics team to ensure that maximum benefits are derived from field level interactions.  

Requirements:

Experience 

Industry Experience: 10+ years of experience in biotech, pharmaceutical, or life science industries. Rare Disease experience is highly advantageous.  

Leadership Experience: Proven track record of leading cross-functional teams (scientific, commercial, and operational teams). An ability to lead and manage the establishment of local business entities. Experience in developing launch strategies for gene therapies. 

Core skills: 

- Strong understanding of biotech business operating models, market dynamics and regulatory landscape 

- Financial acumen (budget management, financial forecasting, demand planning, KPIs) 

- Strategic planning and execution 

- Stakeholder management (internal teams, external vendors) 

- Excellent communication and negotiation skills 

Technology and Tools: 

- Familiarity with biotech-specific software and databases (e.g. CRM systems)

- Proficiency in data analytic tools and reporting systems 

Competencies 

1. Strong leadership and decision-making skills. 
2. High attention to detail and results-orientated mindset. 
3. Ability to manage ambiguity in a fast-paced environment. 
4. Collaborative, with strong relationship-building capabilities 
5. Continuous improvement mindset, with a focus on innovation and operational excellence 

Location 

Based in UK, with occasional travel to cluster countries (Ireland, Sweden, Norway, Denmark and Finland) and EMEA HQ in Switzerland. 

Flex position. 

#LI-DNI   #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager, Quality Assurance Japan, supports the Head of Quality Assurance Japan and leads day to day QA operations to sustain product launch and commercial activities. Partnering with CMC Quality, QC, Technical Operations, and Supply Chain, the role ensures operations aligned with Japanese GMP and GQP—while considering related GDP guidelines, GCP, and PV requirements—and supports the establishment of the local QA support model and supply chain model, providing technical assistance as needed. 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Under the direction of the Head of Quality Assurance Japan, lead day‑to‑day execution of QA activities and contribute to on‑time completion.  
2. Support compliance with internal policies, SOPs, industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; support inspection readiness, day‑of activities, and drafting post‑inspection responses. 
3. Perform batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on quality matters. 
4. Oversee domestic product testing and visual inspection results, and promptly report any manufacturing, quality control, or product quality issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, and relevant stakeholders. 
5. Author, revise, and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards. 
6. Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a safe, uninterrupted, and effective supply of products that meets patient and regulatory expectations. 
7. Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality. 
8. Draft and manage Quality Technical Agreements and, ensure their effective implementation, including support for GxP audits and supplier quality oversight of contracted partners such as CMOs, contract testing laboratories, and distributors.  
9. Provide QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team. 
10. Participate in external collaborations to stay current with domestic policies, practices, and regulatory guidance, and work with CMC Leads and Portfolio Management to support effective project planning and execution. Perform other duties as assigned, as needed. 

Requirements:

1. Bachelor’s degree (or equivalent qualification) in a scientific discipline such as Pharmacy, Biology, Chemistry, or Biochemistry. 
2. At least 7 years of experience in the pharmaceutical or medical device industry, including at least 5 years in a quality organization within a regulated industry. 
3. Experience in product lifecycle management, with an understanding of development through commercialization for small molecules, biologics, and advanced therapies (e.g., gene therapy and mRNA). 
4. In-depth understanding of Japanese GMP and GQP regulations, GDP guidelines, and PMDA/MHLW laws, ordinances, and notifications. 
5. Experience in negotiating and managing quality agreements, as well as vendor relationship and performance management. 
6. Excellent written and verbal communication skills in both Japanese and English, with strong interpersonal skills to collaborate effectively within cross functional teams. 
7. Proficiency in the use of risk assessment and root cause analysis (RCA) tools. 
8. Experience applying quality systems and requirements across preclinical, clinical, and commercial stages. 
9. Strong planning, organizational, and time management skills, with the ability to prioritize and execute multiple projects in a fast paced environment. 
10. Ability to travel domestically and internationally, including Ultragenyx offices in Japan and the United States and vendor sites, as required. 

#LI-CK1 #LI-Remote

Position Summary:

Senior Manager, Quality Assurance Japan は、Head of Quality Assurance Japan と共に日本における品質保証（QA）オペレーションを実務面から支え、製品上市・商業活動を支えるために必要なライセンス維持をサポートします。CMC Quality、QC、テクニカルオペレーション、サプライチェーンと連携し、グローバル（および国内）の GMP・GQPを中心とし、関連するGDPガイドライン、GCP、PVなどの要件との整合を考慮した運営を確保します。また、経営陣および Head of Quality Assurance Japan と協働して、国内の QA サポートモデルとサプライチェーンモデルを整え、必要に応じて技術的支援を提供します。 

Responsibilities:

1. 日本国内の品質保証（QA）業務について、Head of Quality Assurance Japanの指示のもと実務遂行を主導し、期限内の完遂に貢献します。 
2. 社内ポリシー・SOP、業界標準（GMP／GQP／GDP）、PMDA／MHALの法令通知やガイダンス への準拠を監督し、査察対応（事前準備、当日対応、照会事項・指摘事項への回答作成を含む）を担当し、当局とのコミュニケーションを支援します。 
3. 日本のGQP要件に基づき、ロット判定（Batch Disposition） を実施し、品質関連事項について規制当局とのコミュニケーションを支援します。 
4. 国内における製品試験結果・目視検査等を監督し、出荷判定関連業務で把握した製造・品質管理・製品品質に関する不具合 を総括製造販売責任者、Head of Quality Assurance Japan、及び関係責任者へ速やかに報告します。 
5. Ultragenyx Japan の SOP・品質文書 を作成・改訂・運用し、コーポレート基準／品質システム に準拠した運用と継続的改善を推進します。 
6. CMC QA／QC／テクニカルオペレーション／薬事／サプライチェーン と連携し、患者および当局の期待に応える 安全で途切れのない有効な製品供給 を確保します。 
7. グローバル Quality と連携し、変更管理、逸脱／CAPA、品質苦情調査、製品回収 などの品質プロセスを支援・推進します。 
8. 品質契約（Quality Agreements／Quality Technical Agreements） を策定・管理し、委託先（CMO、外部試験機関、物流業者等）への GxP 監査支援／サプライヤー品質 を含め、効果的な実行を確保します。 
9. アートワーク管理 について、品質観点からを必要に応じて支援し、国内委託組織とグローバル技術チームの日本語コミュニケーション を円滑にするサポートを提供します。 
10. 外部コラボレーション へ参加し国内政策・実務・最新ガイダンスを把握するとともに、CMC リード／ポートフォリオマネジメント と協働してプロジェクトの計画・実行・成果達成を推進します。必要に応じて その他の業務 を遂行します。 

Requirements:

1. 科学系分野の学士号（薬学・生物学・化学・生化学など）または同等の資格。 
2. 製薬／医療機器業界での実務経験 7年以上で、かつ規制産業の品質組織での経験 5年以上。 
3. 製品ライフサイクルマネジメントの経験（低分子・バイオ医薬・先端治療〔遺伝子治療、mRNA〕の開発～商業化への理解）。 
4. 日本のGMP／GQP規制、GDP ガイドライン、PMDA／MHLWの法令・通知への深い理解。 
5. 品質契約の交渉・管理、およびベンダー関係・パフォーマンス管理の経験。 
6. 日本語・英語の優れた口頭／文書コミュニケーション能力と、チームで円滑に協働できる対人スキル。 
7. リスクアセスメントおよび根本原因分析（RCA）ツールの活用に習熟していること。 
8. 前臨床・臨床・商業の各段階に応じた品質システム／要件の適用経験。 
9. 変化の速い環境で、複数プロジェクトの優先付けと遂行ができる計画力・組織力・タイムマネジメント能力。 
10. 必要に応じて、 国内外のUltragenyxオフィス（日本／米国）やベンダー施設へ出張できること。 

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

We are seeking an experienced and highly motivated Senior Medical Science Liaison (MSL) to join our team. In this role, you will act as a key link between Ultragenyx and the rare disease medical community, providing critical scientific information about our neurology portfolio pipeline and prepare for commercialization of an anti-sense oligonucleotide for the treatment of Angelman syndrome. The Sr MSL will have a strong clinical and/or scientific background, exceptional communication skills and a passion to shape the future of rare disease medicine and will interact with KOLs and centers of excellence. The Sr. MSL will also build and maintain strong partnerships with cross-functional colleagues and work closely with the Field Medical leadership to ensure execution of the Field Medical plan.

Work Model: 

Field: Officially documented as working as a member of the Ultragenyx field team, generally interacting with third parties on behalf of Ultragenyx

Responsibilities:

· Identify, establish and maintain long-term, strategic scientific relationships with KOLs and proactively liaise appropriately with internal stakeholders ensuring research, scientific, and clinical interests are communicated

· Provide fair balanced presentations and medical information in response to unsolicited questions as appropriate in academic, community, and healthcare provider settings

· Develop and execute US territory and KOL engagement plans to enable high-quality, impactful scientific engagement and education.

· Gather and lead reporting of medical and clinical insights that contribute to enhancement of Ultragenyx’s key medical positions, plans, future research and development efforts.

· Analyzes KOL’s scientific point of view on Ultragenyx’s medical and scientific positions on rare diseases and executes appropriate action plan

· Provide field-based medical affairs assistance for clinical research initiatives supported by the company, related to Investigator Initiated Trials, or other collaborative research and initiatives

· Collaborate with the Clinical Operations organization to enhance patient enrollment in company-sponsored clinical trials by identifying appropriate clinical trial sites and interacting with investigators in ongoing studies

· Leads projects/initiatives internally and represents medical affairs cross-functionally

· Represent Ultragenyx at scientific conferences and meetings, engaging with KOLs and collating scientific data insights. Provide leadership to plan impactful medical engagement activities and deliver timely post-congress insight and competitive intelligence reporting.

· Partner cross-functionally in assigned region, to optimize customer experience

· Ensures all activities are compliant with company policy and procedures, which includes documentation of all relevant MSL activities in CRM platform, management of travel and expense budget, and accurate and timely completion of administrative reports, projects, and required training.

Requirements:

· Terminal degree (e.g., MD, PhD, PharmD) in a clinical or medical specialty and minimum of 2 years prior experience as an MSL

· Candidates with an advanced degree (e.g., MS, MSN, MPH) and at least 5 years MSL experience in a related field to the therapeutic area will also be considered

· Demonstrated technical and scientific expertise in rare disease is preferred

· Demonstrated excellence in delivering high-impact clinical and scientific presentations to expert audiences in both virtual and live settings.

· Exceptional understanding of the health care delivery system and its impact on patient care and regional medical care

· Knowledge in interpreting and adhering to FDA regulations regarding product promotion, scientific exchange, and health care practitioner guidelines

· Thinks strategically and leverages knowledge of general business practices, the industry, medical practices and Ultragenyx strategic objectives to identify field opportunities

· Ability to relate and work with a wide range of people to achieve results

· Ability to work autonomously to organize and prioritize one’s own work schedule

· Ability to build and leverages strategic internal and external relationships to identify potential opportunities and partnerships to provide value and improve quality of care for patients

· Accountable for individual territory management

· Proactively and consistently delivers on commitments, prioritizes time, actions, and resources to meet goals

· Approximately 60% travel in region and nationally is required; overnight travel is required as needed

#LI-CS1 #LI-Remote

Position Summary:

We are seeking a seasoned Senior Network Systems Architect to lead the evolution of our global hybrid network and systems infrastructure. This role requires a strong foundation in Cisco Meraki, Azure Cloud networking, and Cisco ASA. The ideal candidate will bring hands-on expertise in designing, scaling, and supporting both on-premises and cloud environments, while contributing to a secure, reliable, and high-performing enterprise network. 

Familiarity with automation tools such as Python, Terraform, and Ansible is preferred, but not mandatory for success. Experience working with Managed Service Providers (MSPs) and global telecom carriers to negotiate contracts and provision circuits is essential. This position combines architecture with day-to-day operational support, requiring a balance of strategic planning and practical execution. 

ultracurious – Apply your biggest ideas in courageous ways

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:

• Manage day to day operations, Architect, deploy, and manage hybrid infrastructure environments using Cisco Meraki, Azure networking services, and Cisco ASA firewalls 

• Design and templatize scalable Meraki configurations and maintain consistent deployment practices across locations 

• Create and maintain Hub-and-Spoke network architectures across Azure regions, ensuring resiliency, segmentation, and traffic control 

• Provide a solid understanding of routing protocols, Azure routing, UDRs, NAT gateways, VPN/ExpressRoute gateways, and NVA-based architectures with multi-region failover support 

• Develop and maintain architectural documentation including high-level designs, topology diagrams, and operational procedures 

• Support operational excellence by serving as an escalation point for L1/L2/L3 network and systems issues and ensuring timely resolution 

• Perform deep packet inspection and network troubleshooting using tools like Wireshark and NetFlow 

• Participate in the planning, procurement, and provisioning of global circuits, including direct engagement and negotiation with carriers and service providers 

• Collaborate with MSPs and internal teams to manage operations, incidents, capacity planning, and global deployments 

• Familiar with automation tools such as Python, Terraform, and Ansible to streamline network and systems workflows 

• Utilize tools like ThousandEyes, Azure Monitor, and log analytics to ensure observability and proactive incident response 

• Ensure strong cross-functional collaboration with IT security, infrastructure, and compliance teams 

• Support growth and scaling initiatives by addressing evolving infrastructure needs, integrating new locations, and expanding global connectivity 

• Contribute to the recruitment, mentorship, and development of junior and mid-level engineers 

Requirements:

• 7+ years of experience in network and systems architecture, with a blend of cloud and on-premises responsibilities 

• Strong hands-on experience with Cisco Meraki, Cisco ASA, and Azure Firewall, as well as Azure network design and deployment 

• Solid understanding of core networking concepts such as BGP, IPsec, and high-availability configurations 

• Demonstrated experience managing or collaborating with MSPs and supporting global operations 

• Experience negotiating with and provisioning circuits through global telecom carriers 

• Strong analytical and troubleshooting skills, especially in production environments 

• Comfortable handling operational demands, including incident response, change control, capacity planning, and documentation 

• Excellent communication and interpersonal skills, with experience engaging both technical teams and senior stakeholders 

• Ability to manage shifting priorities and infrastructure needs as the company grows and scales globally 

Preferred Qualifications: 

• Bachelor’s degree in computer science, Engineering, or a related field, or equivalent work experience 

• Prior experience working in pharmaceutical or regulated industries 

• Working knowledge of Windows Server, Active Directory, DNS, DHCP, and group policy configurations and core systems operations 

• Experience with zero-trust network design, hybrid cloud security models, and compliance frameworks 

• Certifications such as CCNP, Azure Network Engineer Associate, or equivalent 

#LI-CT1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx Japanでは、希少疾患領域で革新的な治療選択肢を届けるため、担当テリトリーで主体的にビジネスを推進できる営業（UltraCare Liaison MR職）を募集しています。

ムコ多糖症VII型（MPS VII）、家族性高コレステロール血症ホモ接合体（HoFH）、そして2026年上市予定の長鎖脂肪酸代謝異常症（LC‑FAOD）治療薬の情報提供を担い、患者さんフォーカスの環境で成果を生み出すことが求められます。

変革を牽引できるビジネス感覚と高いコミュニケーション力を持ち、新規・拡大市場で実績を築いてきた方に最適なポジションです。

希少疾患領域に貢献したい情熱を持つ方にとって、非常にユニークで稀少なキャリア機会です。

Work Model: 

Field: Officially documented as working as a member of the Ultragenyx field team, generally interacting with third parties on behalf of Ultragenyx.

Responsibilities:

1. 担当テリトリーにおける「MPS VII」「HoFH」「LC-FAOD」治療薬のテリトリープランを策定・実行し、売上目標を達成する。
2. テリトリービジネスオーナーとして、インパクト分析・テリトリー分析を行い、診断、医療従事者教育、治療アクセス向上を最適化する。
3. テリトリーおよびアカウントプランを通じて Patient Identification と市場開発を推進し、販売機会を継続的に評価しながらビジネスを維持・成長させる。
4. 社内外の多様なステークホルダーと効果的な関係を構築し、コミュニケーションスタイルを柔軟に調整しつつ、合意形成と意思決定をリードする。
5. Ultragenyxの方針、SOP、コンプライアンスに基づき、Key Opinion Leaderや医療従事者とのエンゲージメントを推進する。
6. 重要アカウントに対して適切・効率的なカバレッジを実現するため、日次／週次で出張計画およびコールプランを立案・実行する。
7. PMS（市販後調査）を適切かつ迅速に収集し、関連部門と連携して正確な情報提供・報告を行う。
8. スタートアップ環境の一員として、社内プロセスや業務ルールの構築に貢献し、定量・定性の両面で担当エリアを超えた全国レベルのインパクトを示す。 

Requirements:

1. 学士号以上を有し、サイエンス／ヘルスケア関連領域で10年以上のビジネス経験（うち8年以上はヘルスケアまたはバイオテック業界）。希少疾患や家族性高コレステロール血症（HoFH）、代謝異常症領域の経験があれば尚良い。
2. 事業戦略の立案力・洞察力を持ち、主体的に周囲をリードできること。
3. メディカル、クリニカルオペレーション、Patient Services などと連携し、部門横断で業務を推進した実績。
4. 臨床・科学情報を正確かつ効果的に医療従事者へ説明／プレゼンできる能力。
5. 指示待ちではなく、自ら考え行動し、物事を前に進める Hands‑on 型の働き方ができること。
6. 英語力があれば尚可（グローバルとのコミュニケーションや科学資料の読解が発生）。
7. 約60〜70％（テリトリーにより変動）の出張に対応でき、必要に応じて宿泊を伴う出張が可能であること。
8. 成果のみならず質的な貢献を通じ、担当エリアを超えて組織全体にポジティブな影響を与えられること。

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Ultragenyx Japan is seeking highly driven UltraCare Liaisons who can independently lead business activities within their assigned territories to deliver innovative therapies in rare diseases. 

This role will be responsible for field engagement for MPS VII, HoFH, and the LC‑FAOD therapy planned for launch in 2026, operating in a deeply patient‑focused environment. 

We seek individuals with strong business acumen, excellent communication skills, and a proven track record in establishing and expanding sales in new or evolving markets. 

For those passionate about making a meaningful impact in rare diseases, this position represents a unique and exceptional career opportunity. 

Work Model: 

Field: Officially documented as working as a member of the Ultragenyx field team, generally interacting with third parties on behalf of Ultragenyx.

Responsibilities:

1. Develop and execute territory business plans for MPS VII, HoFH, and the launch plan for LC-FAOD treatments within the assigned territory to achieve sales targets. 
2. Act as the territory business owner, conducting impact and territory analyses to optimize patient diagnosis, HCP education, and treatment access. 
3. Drive patient identification and market development by building and executing territory and account plans, continuously assessing opportunities to sustain and grow the business. 
4. Build effective relationships with internal and external stakeholders, adapting communication styles to drive alignment and facilitate decisions. 
5. Engage with current and potential KOLs and HCPs in alignment with Ultragenyx policies, SOPs, and compliance requirements. 
6. Develop and execute daily/weekly travel and call plans to ensure optimal and efficient coverage across key accounts. 
7. Ensure timely and accurate collection of post‑marketing surveillance (PMS) data and collaborate with relevant teams on reporting. 
8. Contribute to building internal processes and business rules in a start-up environment, demonstrating impact beyond the assigned territory at a national level. 

Requirements:

1. Bachelor’s degree or higher with 10+ years of business experience in science related fields, including 8+ years in healthcare or biotechnology. Experience in rare diseases, Familial Hypercholesterolemia (HoFH), or metabolic disorders is highly preferred. 
2. Strategic business acumen with the ability to naturally lead and influence stakeholders. 
3. Demonstrated cross functional collaboration with medical, clinical operations, patient services, and other internal stakeholders. 
4. Ability to effectively present and explain clinical and scientific information to healthcare professionals. 
5. Hands on mindset with the ability to think independently, act proactively, and drive initiatives forward. 
6. English proficiency is an asset, particularly for engaging with global teams and reviewing scientific materials. 
7. Ability to travel approximately 60–70% of the time (depending on territory), including required overnight travel. 
8. Ability to deliver qualitative impact beyond the assigned territory and contribute positively at the broader organizational level.

#LI-CK1 #LI-Remote

Position Summary:

ultraimpact – Make a difference for those who need it most

We are looking for experienced UltraCare Liaisons (UCLs) that will represent Ultragenyx in the Rare Disease Community, responsible for the promotion of Dojolvi for the treatment of long chain fatty oxidation disorders (LC-FAOD). Ultragenyx is also preparing for the potential commercialization of two investigational novel gene therapies in MPSIIIA and GSD1a. We are seeking driven individuals with the desire to run their own business within a specified geography. These individuals will have strong business acumen, be able to drive change through innovative approaches, demonstrate excellent communication skills and consistently deliver sales results.

Work Model: 

Field: Officially documented as working as a member of the Ultragenyx field team, generally interacting with third parties on behalf of Ultragenyx. 

Responsibilities:

1. Serve as territory business owner with a focus upon impact and territory analysis. Other key areas of focus include optimizing: i) patient diagnosis and care through HCP education, ii) educating HCPs about Ultragenyx approved products, iii) assisting with treatment fulfillment
2. Ability to develop and nurture effective business relationship management with key stakeholders, including HCPs, Registered Dieticians, Genetic Counselors, Pharmacists, and related support staff
3. Proactively builds effective working relationships with internal/external stakeholders; can drive agreement/decisions from multiple stakeholders; ability to understand people’s emotions and flex communication style. Can adjust their approach based on different stakeholder needs, concerns, or audience member to drive alignment and meet their work goals.
4. Develop and maintain a strategic territory business plan focused on key academic centers, community targets within priority specialties, territory opportunities and challenges.
5. Determines and implements suitable travel schedule and call plan on a daily/weekly basis to ensure both adequate and highly effective coverage for all key accounts.
6. Executes programs, high impact in-services, and other educational opportunities for their territory.
7. Timely completion of compliance trainings, internal product & disease state trainings, Veeva administration, monthly expense reports, and all other administration expectations.

Requirements:

1. Bachelor’s Degree required
2. 8 years with 5+ years being in the healthcare/biotech industry, inclusive of 3 years of field-based experience in account management, sales, and/or field reimbursement. Rare disease experience is preferred.
3. Experience launching biopharma/pharma products successfully is preferred
4. Documented track record of field sales success
5. Strategic business acumen and cross-functional and collaborative leadership with internal stakeholders including marketing, medical, clinical operations, and patient services.
6. Demonstrated experience effectively presenting clinical/scientific information required
7. Approximately 50 - 60% (dependent on geography) travel is required; overnight travel is required as needed
8. Must live in territory geography. Territory includes: Washington, Oregon, Idaho, Montana, Wyoming, Northern California. Territory subject to change based on business need

#LI-NB1 #LI-Remote

Position Summary:

Ultradedicated – Your biggest challenges yield rare possibilities

The National Field Leader will establish launch strategy for the field sales teams, performance drivers and the resourcing plans to support the Ultragenyx Neurology therapeutic area. This leader will possess broad experience in leading teams, business ownership, analytics, driving performance, and the implementation of innovative solutions. The National Field Leader will need to formulate an effective national go-to-market plan, while allowing territorial variations, including establishing both short- and long-term success factors and appropriate KPIs. It will be the responsibility of the National Field Leader to provide direction related to key objectives within the territories and implement a national field plan that is organizationally approved and fully compliant with all applicable laws and the company code of conduct.  

Work Model: 

Field: Officially documented as working as a member of the Ultragenyx field team, generally interacting with third parties on behalf of Ultragenyx. 

Responsibilities:

1. Build and lead a national field sales team consisting of multiple regions and territories in each region.  
2. Mentor and coach regional leaders to effectively manage their teams – providing constructive feedback and coaching to achieve superior performance and leading efforts in field sales employee development 
3. Set launch and growth objectives while aligning with the marketing strategy and priorities. Ensure the sales and marketing strategies, programs and tactics are uniformly adopted and implemented by the sales force members, within the parameters of the company’s operating values, culture, to achieve product sales market share and revenue goals.  
4. Operate in the best interest of patients and providers, ensuring a ‘patient-first’ focus, demonstrating the highest ethical and moral standards 
5. Ensure that the UltraCare Liaison (Rare Disease Field Sales) team is equipped & trained to address field market requests, customer service issues and challenges, with a sense of urgency and accountability  
6. Understand healthcare trends in the Rare Disease Community and create pull-through tactics and solutions to mitigate market access challenges  
7. Employ strong organizational and analytical skills to optimize growth, including the ability to analyze complex data to develop strategic and actionable business plans  
8. Develop and implement key sales team processes such as incentive plans, communication plans, recognition programs, performance management   
9. Conduct regular business and performance reviews for all direct reports and their team members, and effectively manage under-performers  
10. Lead and maintain a culture of compliance, integrity and transparency  

Requirements:

1. Minimum of bachelor's degree; Advanced degree highly preferable Minimum of 15+ years of experience in sales with at least 3 years in a leadership position in rare/ultra-rare disease driving growth businesses  
2. Lead with emotional intelligence while thriving in a rapid-paced and dynamic environment that aligns with Ultragenyx values.  
3. The National Field Leader will serve as a role model for the culture that relies on teamwork and collaboration using a blend of science and business skills and experience  
4. Strong business relationships in the Rare Neurology community with an in-depth understanding of the clinic multidisciplinary team environment 
5. Must have experience launching an ASO (antisense oligonucleotide) product
6. Motivational and inspirational leader who can affect change, collaborate well with other cross-functional leaders and executive-level leaders and demonstrated success in launching new therapies 
7. Experience building high performing teams, with a focus on culture, compliance and launch excellence  
8. Approximately 75% travel is required including overnight travel as needed  

#LI-AM1 #LI-Remote

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

This role supports the development and execution of medical strategies in Japan, leveraging nutrition science or biochemistry and/or pathologic nutrition or a related field, expertise to guide research planning and evidence generation. 
The position primarily supports Ultragenyx’s development stage and commercialized products in Japan. 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Develop and execute medical strategies focused on the program’s mechanism of action, including dietary therapy–related mechanisms, within the field of metabolic disorders. 
2. Lead and provide scientific input to support field medical team and evidence generation from a metabolic disorders perspective.　 
3. Serve as a subject matter expert and strategic partner to Japan Medical Directors, leading the generation of  medical strategies as the biochemical and pathologic nutrition expert. 
4. Collaborates closely with Global Metabolic Nutrition Programs to ensure alignment of nutrition related scientific content and field communications.
5. Collect and share up to date scientific information on nutrition and metabolic disorders. 
6. Analyze and report findings from scientific literature and conference proceedings. 
7. Support the development of educational materials and internal training related to metabolic disorders. 
8. Ensure all activities comply with company policies, SOPs, and relevant compliance standards. 
9. Support scientific information exchange and insight gathering at congresses and external events as needed. 

Requirements:

1. Advanced degree (PhD or MS) in Nutrition Science, biochemistry and/or pathologic nutrition or a related field, with research experience required. 
2. Research experience in Nutrition Science and/or Biochemistry and/or metabolic disorders  
3. 3+ years post graduate experience in pharmaceutical industry, research or other relevant experience required. 
4. Clinical experience as a Registered Dietitian (e.g., patient counseling, nutrition management, or practical work in clinical settings) is preferred. 
5. Experience in rare diseases is a plus. 
6. Native level Japanese and business level English proficiency (reading, writing, and communication). 
7. Strong communication and teamwork skills to collaborate effectively with internal and external stakeholders. 
8. Demonstrated hands-on experience in analyzing, summarizing, and presenting scientific content. 
9. Ability to work independently and manage multiple priorities. 
10. Primarily remote or office based; able to support limited field activities (e.g., domestic travel and congress participation) as needed. 

#LI-CK1#LI-Remote

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

日本におけるメディカル戦略の立案・実行を支援し、栄養科学、生化学、病態栄養学、または関連分野の専門性を基盤として研究計画やエビデンス創出をリードする。 
国内でのUltragenyxの開発品および上市製品に対するメディカル活動を主たる責務として支援する。 

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. 代謝性疾患領域において、食事療法に関連するメカニズムを含むプログラムの作用機序（MOA）に焦点を当てたメディカル戦略を立案・実行する。 
2. 代謝性疾患の専門家として、フィールドメディカルチームおよびエビデンス創出活動を主導し、科学的方針およびインプットを提供する。 
3. 代謝性疾患の観点から、フィールドメディカルチームの活動およびエビデンス創出を支援するための科学的インプットを提供する。 
4. グローバル・メタボリック・ニュートリション・プログラム（Global Metabolic Nutrition Programs）と密に連携し、栄養に関連する科学的コンテンツおよびフィールドでのコミュニケーションの整合性を確保する。
5. 栄養科学および代謝性疾患に関する最新の科学情報を収集・共有する。 
6. 学術論文・学会発表の内容をレビューし、分析・要約・報告する。 
7. 代謝性疾患に関連する教育資材の作成および社内トレーニングを支援する。 
8. 社内方針およびSOP、関連コンプライアンス要件を遵守して、すべての活動を遂行する。 
9. （必要に応じて）学会や社外イベントでの科学情報提供・情報収集をサポートする。 

Requirements:

1. 栄養科学、生化学、病態栄養学のいずれか、または関連分野における高等学位（PhD または MS）を有し、研究経験を必須とします。 
2. 製薬業界、研究、またはその他の関連分野における大学院修了後3年以上の実務経験を必須とします。 
3. 管理栄養士としての臨床経験（患者指導、栄養管理、医療現場での実務等）があれば尚可とします。 
4. 希少疾患領域の経験が、あれば歓迎します。 
5. 日本語はネイティブレベル、英語はビジネスレベルの読解・文書作成・コミュニケーション能力を要します。 
6. 社内外ステークホルダーと円滑に連携できる高いコミュニケーション力およびチームワーク力。 
7. 科学的内容の分析・要約・資料作成およびプレゼンテーションに関する実務経験。 
8. 自律的に業務を進め、複数の優先事項を整理・管理できる能力。 
9. 原則リモートまたはオフィス環境で勤務しますが、業務上必要に応じて限定的な現場活動（国内出張、学会参加など）に対応できること。 

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Business Operations Lead will be responsible for driving the efficient execution of business operations, ensuring alignment between commercial, medical and other operational functions. The individual will work closely with the VP GM to define strategic priorities, improve processes and oversee day-to-day business activities in a fast paced, dynamic biotech organization that covers Germany, Austria and Switzerland. This person should have experience with sales & marketing, financial, supply chain and operational processes. The ideal candidate knows how to navigate the health care systems in the countries of the cluster.  

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Operational effectiveness: Identify efficiencies and implement local solutions to improve productivity and scalability in the cluster. 
2. Strategic and tactical planning: Support the VP GM in collaborating with all functions to prepare and execute brand plans, new product launch plans, launch readiness metrics & dashboards, quarterly business reviews and long-range planning. Ensure pull-through of identified EMEA initiatives to local markets. 
3. Go to Market Gene Therapy Operations: Collaborate with the EMEA Gene Therapy launch team(s) to prepare and optimize local (site) readiness for gene therapy launches.  
4. Supply Chain Optimization: Partner with supply chain to enhance and develop product distribution in all markets. Lead and mange Home Delivery and Infusion services. 
5. Project Management: Planning and independent execution of key projects, in particular operational marketing, market mapping and insights management, ensuring timelines, budgets and deliverables are met. Manage project budgets and third-party vendors to ensure optimal resource use. In close collaboration with commercial and medical field teams, develop materials to communicate to key stakeholders about Ultragenyx key products.  
6. Cross functional Cluster leadership and governance support: Support the VP GM in driving agenda preparation, slide preparation and leadership of key strategic operational meetings, offsites and forums.  
7. Compliance & Risk Management: Ensure adherence to local regulations e.g. AMG, BPI/AKG Code of Conduct etc. and mitigating operational risks 
8. Analytics and Insights generation: collaborating with the Regional Analytics team to ensure that maximum benefits are derived from field level interactions.  

Requirements:

Education 

1. Bachelor’s degree (required) in: 

Pharmacy, Medicine, Biology or Life Sciences, Business Administration or Management 

1. Advanced Degree (preferable) in: 

Master of Business Administration (MBA), Masters/PhD in a life science discipline 

1. Certifications (optional): 

Project management,  

Experience 

Industry Experience: 10+ years of experience in biotech, pharmaceutical, or life science industries. Rare Disease experience is highly advantageous.  

Leadership Experience: Proven track record of leading cross-functional teams (scientific, commercial, and operational teams). An ability to lead and manage the establishment of local business entities. Experience in developing launch strategies for orphan drugs, particularly gene therapies, is desirable. 

Core skills: 

1. Strong understanding of biotech business operating models, market dynamics and regulatory landscape 
2. Familiarity with German health care system 
3. Financial acumen (budget management, financial forecasting, demand planning, KPIs) 
4. Strategic planning and execution 
5. Stakeholder management (internal teams, external vendors) 
6. Excellent communication and negotiation skills)