Scientist I, Upstream Process Development - Gene Therapy
Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.
US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
Roles based outside the US: If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.
Position Summary
ultrainnovative – Tackle rare and dynamic challenges
Ultragenyx has multiple Gene Therapy programs in development in the rare and ultrarare disease space, a robust pipeline. We are building a state of the art GMP manufacturing facility in Bedford, MA. Join our team!
Reporting to the Associate Director Upstream Process Development, the Senior Research Associate/Scientist I is expected to lead, design, and conduct experiments aimed at defining robust bioreactor processes for the production of AAV vectors in HeLa and/or HEK293 Producer cell platforms and help develop robust and scalable processes suitable for cGMP production.
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
- Independently/Semi-independently lead development of a gene therapy program(s) as upstream process subject matter expert.
- Lead project/program experiments including planning and executing experiments across the Upstream Process Development team for AAV production
- Design and apply DOE to develop, refine, optimize and characterize cell culture and vector production processes.
- Apply engineering concepts to develop and scale the mammalian cell culture processes, including transient transfection, infection-based processes, clarification of harvested material, and other upstream unit operations.
- Conduct laboratory studies to enhance AAV manufacturing technologies, capabilities, and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
- Conduct well-designed experiments and troubleshoot process and equipment when needed.
- Generate, manage, evaluate, and maintain critical data in a highly organized manner. Help improve and maintain ELN templates and complete experiment write-ups in timely manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
Requirements
- PhD in Biochemical Engineering or Biological Sciences with 0-2 years’ experience
- Experience with small- or large-scale single-use bioreactor operations, and technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.
- Familiarity with development of viral vectors, live viral vaccines, producer cell lines, high throughput or disposable bioreactors, culture media development, or perfusion unit operations is preferred.
- Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
- Ability to execute and follow-through to completion and documentation. Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.
- Strong team player-Must work well within teams in highly collaborative environment, where equipment and space are shared with wider pharmaceutical development team.
#LI-LM1
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
· Generous vacation time and public holidays observed by the company
· Volunteer days
· Long term incentive and Employee stock purchase plans or equivalent offerings
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
* Benefits vary by region and country
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
See our Privacy Policy.