American Society for Cell Biology

Scientist I/II, Quality Control - Cellular Virology

Ultragenyx Gene Therapy
Woburn, Massachusetts, United States
12 days ago

Description

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 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 approach will include video discussions, interviews, and onboarding.
Position Summary
ultradedicated – Your biggest challenges yield rare possibilities
 
Reporting to the Director or Associate Director, QC Virology, the Scientist I/II - QC Cellular Virology will support the UGT portfolio of clinical development programs to ensure timely delivery of clinical supplies. The Scientist I/II - QC Virology will engage the technology transfer from R&D or external laboratories to QC, execute the method development, qualification and validation, and establish analytical procedure SOPs, testing forms and processes for critical reagent qualification. The incumbent will support cellular virology and associated molecular biology method development and validation as well as method troubleshooting at CTOs/CMOs.
 
The Scientist I/II - QC Virology will manage the Cellular Virology lab, perform routine GMP testing of AAV vectors and Ad5 analytical methods (TCID50, rcAAV, residual infectious Ad, and other methods as needed), and support viral clearance studies. The incumbent will be responsible for reviewing, authorizing, and analyzing all test data in Cellular Virology.
 
The Scientist I/II – QC Virology will support managing various biological bank activities and be responsible for the preparation of specification, test data review, and issuance of COA for mammalian cell bank, viral bank, plasmid and E.coli cell bank.  
 
The Scientist I/II - QC Virology will execute QC quality system activities to ensure virology operation in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials and eventual commercial products. The incumbent will prepare QC document to support regulatory filing.


Requirements

Responsibilities

    • Lead and execute the technical transfer, development and validation of cell based viral assays such as TCID50, rcAAV, PCR, and other methods for lot release and stability study as well as viral clearance studies. Write method development/validation protocols and reports with some/minimal supervision.
    • Establish various virology test SOPs for release test and reagent qualification. Perform cell based viral assays, review and authorize test data to generate characterization, release and stability data.
    • Lead and/or support biological bank programs and collaborate cross-functionally for production/test scheduling and releasing of various MCB and WCB of bacteria, viruses, and mammalian cells. Prepare specifications, review and authorize the test data and generate COAs for cell banks and plasmids.
    • Manage and ensure the working condition of the cellular virology laboratory including adequate supplies of reagents and materials and execute the routine lab and equipment maintenance activities including timely logbook review.
    • Work independently to review and trend QC data including control chart and stability data and generate analytical method performance trending reports.
    • Write QC virology related documents to support regulatory filing.
    • Execute QC QS activities such as OOS/invalid investigation, deviation, change control, CAPA, and training curricula.
    • Work with cross functional teams associated with cellular virology topics and support CTO/CMO in virology method development/validation and troubleshooting.
    • Support other QC activities or situational projects upon request.

Requirements

    • BS, MS, or Ph.D. in Virology, Cell Biology, Molecular Biology, Biochemistry, Microbiology or a related discipline with 4+ years industry experience
    • Experience with viral propagation and cell based infectious assays required, and experience with routine cell culture strongly desired
    • Experience developing and qualifying biological methods in one of the following areas: TCID50, cell-based assays, and molecular biology assays  
    • Experience in QC cGMP operation preferred
    • Experience drafting validation protocols, data reports and QC/QA compliance documents
    • Experience with statistical analysis of analytical data and stability studies preferred
    • Experience with viral vectors is not required but experience with biologics preferred
    • Familiarity with qPCR and/or ddPCR
    • Ability and desire to work in a fast-paced, start-up environment
    • Strong collaboration, team-working skills and communication skills
    • Independently motivated and detail-oriented with good problem solving ability
#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.
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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 totalentacquisition@ultragenyx.com.

Job Information

  • Job ID: 57854427
  • Location:
    Woburn, Massachusetts, United States
  • Position Title: Scientist I/II, Quality Control - Cellular Virology
  • Company Name: Ultragenyx Gene Therapy
  • Job Function: Quality Control,
    Scientist
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 3-5 Years
  • Required Travel: 0-10%
Biotechnology
Cambridge , MA ,

Why Join Us? Be a hero for our rare disease patients Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target 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 treatin...

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