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Senior Director, Quality Control Internal Testing

Company: Disability Solutions
Location: Woburn
Posted on: September 19, 2023

Job Description:

Why Join Us?Be a hero for our rare disease patientsAt 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 .Position Summary: ultra focused - Work together to fearlessly uncover new possibilities As Senior Director, Quality Control Internal Testing, you will lead lab testing groups (Microbiology, Chemistry, Bioassay, Virology, Molecular) and support our continued growth in test result delivery, new method transfer and validation, and compliance as we transition from late stage clinical to commercial GMP. The QC lab in Woburn MA supports testing from both externally manufactured and internally manufactured AAV gene therapies from our newly opened manufacturing facility in Bedford, MA. Scope includes in-process, release and stability of Drug Substance and sterile Drug Products. Position reports to Executive Director of QC. Ultragenyx has multiple Gene Therapy programs in development in the rare and ultrarare disease space, and a robust pipeline. We are building a state of the art GMP manufacturing facility in Bedford, MA. Join our team! 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:

  • Lead Microbiology, Molecular, Bioassay, Chemistry, and Virology lab groups. Techniques include Bioburden, HPLC, CE, ELISA, q/dd/dPCR, Cell Culture, In Cell Western, Enzyme Activity, LC/MS.
  • Ensure PLI/PAI readiness, commercial level GMP compliance, and successful Health Authority inspections (FDA, EMA, etc).
  • Drive continuous improvement in lab operations/systems and result/CoA delivery to business.
  • Optimize cross-lab collaboration, resource utilization, training, instrumentation usage, invalid assay, OOS, and review processes.
  • Directly supervise 4-5 AD/Director level leaders and -30 total lab scientists/analysts
  • Interface with other QC areas (CMC, Operations, GTMF QC) and partner groups (Manufacturing, MSAT, AD, Regulatory, Quality Assurance) Requirements:
    • Minimum B.S. degree in preferably Microbiology, Chemistry, or Biochemistry
    • 15+ years of experience in biopharmaceutical or biotechnology based GMP
    • 8+ years of direct supervisory experience of technical or quality professionals
    • Must have commercial QC lab supervisory experience
    • Must be able to work on-site at least 4 days per week
    • Knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections Management Skills:
      • Clarify Direction & Priorities :Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.
      • Partner & Collaborate Effectively : Listen to and value others' thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
      • Support Learning & Growth : Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others. #LI-CZ1 #LI-Onsite 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. 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 countryUltragenyx Pharmaceutical is an equal opportunity employer and 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, as required by applicable law. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by calling (415) 483-8800 or emailing us at .See our CCPA Employee and Applicant Privacy Notice . See our Privacy Policy .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 : .

Keywords: Disability Solutions, Boston , Senior Director, Quality Control Internal Testing, Executive , Woburn, Massachusetts

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