Director, Biologics CMC QC, Europe

☞ Ultragenyx Pharmaceutical

View: 172

Update day: 26-03-2024

Location: Allschwil Basel-Landschaft BL

Category: Beauty / Wellness

Industry:

Job type: Temps plein, Temps de travail : 90-100%

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Job content

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.

US based roles: starting on January 3rd, 2022, 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.

Position summary
ultradedicated –Your biggest challenges yield rare possibilities

As Director, CMC Quality Control, you are responsible for quality control oversight in the production of clinical trial and commercial products. You proactively manage and engage contract manufacturing and research organizations to ensure that appropriate quality standards, regulatory requirements and contract expectations are met during production (in-process controls) and testing for disposition of our products (product release, stability, comparability, etc.). You collaborate closely with cross-functional departments and stake holders to achieve corporate goals and objectives, as well as with program CMC core teams to develop and implement manufacturing and regulatory drug substance and drug product specifications. You prepare and author CMC Quality control sections for BLA/IND filings and Health Authority communications for area of expertise (e.g. Information Requests (IRs) from global regulatory agencies). In this role, you report to the VP Analytical Development & CMC QC.

What you will be doing

    • Partner with Ultragenyx analytical development and/or contract analytical development labs to ensure robust phase appropriate method development to enable successful method qualification and validation
    • Manage the qualification and validation of analytical test methods for clinical, commercial products, and intermediates in accordance with ICH/EU/FDA/USP/Ph. Eur. guidelines
    • Author, update, and revise CMC regulatory filing sections to support regulatory filings
    • Manage the generation, execution and technical review of analytical data, laboratory documents, method validation protocols, method validation summary reports, and method development reports.
    • Participate in the selection of CMOs and CLs for of new and existing programs / projects
    • Ensure compliance with current GMP’s in a manufacturing environment to ensure that the products are assessed to agreed-upon specifications and in alignment with regulatory requirements in a timely manner in order to support in-process, lot release and stability testing
    • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA/EU guidelines
    • Maintain QC project plans and their associated timelines
    • Perform QC related deviation investigations and CAPA implementation in support of QC projects and improvement
    • Support inspections/audits (regulatory or internal) and author audit observation responses when necessary
    • Responsible for planning, tracking, monitoring and adhering to annual budget
    • Working in a Matrix organization – support internal projects including gene therapy and mRNA related assets as required
    • Supervise a small team or contractors where applicable
    • Champion, lead and participate in continuous improvement activities for the quality control operations
    • Engage and support regular QC operations review for all Commercial and Clinical assets.
    • Participation in external technical conferences and presentation
    • Participation in a continuous management and leadership training programs offered by the Company

What you bring to the role

    • Bachelor’s degree in Biochemistry, Chemistry, Biology, or a related field required; graduate degree is highly desirable
    • Experience with a minimum of 12 years in a GMP environment (Biopharmaceutical Industry) with at least 8 years in analytical method qualification, validation and life cycle management.
    • Experienced in executing analytical and biochemistry test methods validations and methods life cycle management.
    • Experienced in Biological molecules methods, including RP-HPLC, IEX, SEC, SDS-PAGE, ELISA and Bioassay, Western blot, 2D western blots, CE and CIEF. Expertise and familiarity with most of the following characterization techniques including LC-MS, MALDI-TOF-MS, CD, FTIR, DSC techniques.
    • Excellent oral and written communication skills in English and German, and proven ability to work autonomously and manage effectively in a matrix environment
    • Proficiency in MS Office, Word and Excel - Proficiency in statistical analysis (e.g. JMP) software desired
    • Attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines
    • Excellent interpersonal and verbal communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company
    • Travelling to the US head office and other CMO/CRO sites will be required (once restrictions are lifted) - 25%
Applicants are in possession of valid work permit for Switzerland

Full-time employee benefits include some of the following, but not limited to:
  • Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
  • Long-term Incentive and Employee Stock Purchase Plans
  • Paid parental, adoption, and caregiver leave
  • Wellness Offering
  • Deferred compensation for specific roles
  • Fitness reimbursement
  • Tuition Reimbursement
  • Professional development programs

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 attalentacquisition@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 to:talentacquisition@ultragenyx.com.
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Deadline: 10-05-2024

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