Compliance Coordinator

Company: Ultragenyx Pharmaceutical
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Ultragenyx - Gene Therapy - Manufacturing / 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 treating the underlying disease. Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, 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: The GMP Compliance Coordinator is responsible for providing direct and detailed GMP manufacturing support for UGT's deviations, CAPA's, change controls and IND authoring Responsibilities

• Partner with the UGT Team including PD, MFG. MSAT and QA to draft and investigate internal deviations, CAPAs and change controls.
• Support all phases of the clinical and commercial manufacturing including technology transfer, production campaign, deviation evaluation and investigation, batch disposition, and campaign conclusion and summary.
• Act as the key technical manufacturing support for the CMO by attaining an in-depth understanding and knowledge of the UGT gene therapy manufacturing processes, materials, equipment, and batch documentation to be able to quickly assess issues and propose solutions to challenges.
• Create and track metrics for internal deviations, CAPAs and change controls.
• Author IND section for regulatory filings as needed
• Partner with CMOs to coordinate and drive deviation closure
• Partner with CMO and internal UGT QA to track CMO deviation, batch record review and lot release metric's
• Maintain manufacturing department training curricula and metrics-- Requirements
  • BS in a scientific field of study with 4-7+ years of relevant experience working in GMP Manufacturing/Contract Manufacturing in the Pharmaceutical/ biotech industry
  • Experience in a GMP clean room environment including sterile technique and gowning
  • In-depth technical understanding of GMP biologics manufacturing and general awareness of international regulations and standards
  • Proven ability to work independently, leadership aptitude and good people skills with the desire and ability to work in a fast-paced, start-up environment
  • Strong collaboration and team-building, communication, and organizational skills required
  • Experience with trouble-shooting and providing solutions to complex technical and logistical issues
  • Excellent written and verbal communication skills
  • Travel: approximately 25%-- #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. 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 .

Keywords: Ultragenyx Pharmaceutical, Cambridge , Compliance Coordinator, Other , Cambridge, Massachusetts