Ultragenyxpharmaceutical
Director, CMC QC Small Molecules
South San Francisco, CA · Director
Sponsorship not specifiedDetected 18 hours ago
Performance ManagementLeadership
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- ultra dedicated - Your biggest challenges yield rare possibilities
- This position reports to the Executive Director, CMC ‑ QC.
- Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs.
Responsibilities
- Perform technical review and approval of outsourced analytical data, method validation, stability programs, reference standards, specifications, and shelf ‑ life assignments, ensuring phase ‑ appropriate QC strategies and data integrity.
- External Partner & CMO/CL Management
- Lead the selection, qualification, and performance management of CMOs and contract laboratories, serving as the QC technical representative during manufacturing campaigns and managing quality agreements, scopes of work, and issue resolution.
- Lead selection, qualification, onboarding,
Benefits
- 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 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.
- Collaborate cross ‑ functionally and lead CMC QC contributions to regulatory submissions, inspections, and audits, including authoring and defending QC sections and managing responses to health authority observations.
Company info
- 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.
- 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.
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