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Job Details

Scientist I Downstream Process Development - Gene Therapy

Company name
Ultragenyx Pharmaceutical

Location
Woburn, MA, United States

Employment Type
Full-Time

Industry
Biotech, Sciences, Scientist, Chemistry, Engineering

Posted on
May 12, 2020

Valid Through
Aug 25, 2020

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Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

With the company’s recent acquisition of Dimension Therapeutics, the Ultragenyx Gene Therapy division was established. The Ultragenyx Gene Therapy division is headquartered in Cambridge, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding.

Position Summary

Reporting to the Associate Director, Downstream Process Development, the Scientist I will support the research and development of advanced purification methods and formulation development for AAV vectors.

Responsibilities:

Provide scientific leadership and define experimental strategy for early and late stage development studies for the production of high quality AAV vector products.

Design and execute development studies to evaluate new technologies, improve existing platforms and develop new platforms for high titer and high purity AAV products. Lead or support the development of 2nd generation downstream process for the late phase programs.

Lead and execute late phase process characterization activities including: risk assessments, scale down model qualification, pre-characterization and characterization experiments, viral clearance studies, and development of the PPQ and commercial process control strategy.

Support process transfer and scale up. Apply engineering concepts to the screening, optimization and scale-up of chromatography (affinity, ion exchange, size exclusion) and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.

Collaborate within cross-functional teams (Upstream Process Development, Analytical Development, Pilot Plant, Technology Transfer, Quality, and Manufacturing) to deliver required CMC activities.

Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, process descriptions, study protocols and reports, risk assessment documents, process characterization documents, and control strategy documents. Prepare scientific presentations as needed. Write/revise SOPs as needed.

Support business development programs and technology transfers.

Support regulatory filings and response to health authority questions. Author and review CMC sections for IND and BLA submissions.

Qualifications:

MS or PhD in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline

5 years (MS) or 0-5 years (PhD) relevant industrial experience in bioprocessing

Recent industrial experience with late-stage development and characterization of biologics or vaccine upstream process is highly preferred.

Expertise with GE AKTA units, column chromatography, filtration and UF/DF (TFF) operations required. Experience with High Throughput Screening platforms such Tecan will be a plus.

An in-depth understanding of purification of viral vectors, live viral vaccines, or large molecule biologics, including process scale-up and tech transfer.

Understanding of analytical methods used to support biologics purification process development is needed

Experience with high-throughput process development and statistical design of experience (DoE) preferred.

Experience with technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.

Should be highly motivated, demonstrate strong technical leadership skills, 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.

Independently motivated, detail oriented and good problem solving ability.

Experience in working with and managing outside vendors.

#LI-CZ1

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 CCPA Employee and Applicant Privacy Notice

Note to External Recruiters

: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to :

talentacquisition@ultragenyx.com

Company info

Ultragenyx Pharmaceutical
Website : http://www.ultragenyx.com

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