Director, CMC QC Small Molecules

Ultragenyx Pharmaceutical•South San Francisco, CA

3d•Hybrid

About The Position

At Ultragenyx, we are dedicated to leading the future of rare disease medicine by challenging the status quo and creating a new model that advances the field. We achieve 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. Our commitment extends to our people, fostering a supportive and inclusive environment of profound learning and growth. We aim to be an organization where employees can have a meaningful impact, do the best work of their careers, and grow professionally and personally.

Requirements

Bachelor’s degree with 14+ years or Master’s degree with 10–12+ years, or PhD with 8–10+ years of relevant GMP experience in chemistry, pharmaceutical sciences, biochemistry, or a related discipline.
Minimum 5–8+ years of direct CMC QC experience supporting small molecule drug substance and drug product, including commercial assets.
Demonstrated hands-on expertise with small molecule analytical techniques, including HPLC/UPLC, LC-MS, GC, dissolution, Karl Fischer, particle size, residual solvents, impurity profiling, and compendial safety testing.
Strong working knowledge of ICH, FDA, EMA, USP, and Ph. Eur. requirements applicable to small molecule development and commercialization.
Proven experience overseeing external QC laboratories, CMOs, and contract testing organizations, including technical governance and performance management.
Experience supporting global regulatory submissions and health authority inspections, including defense of outsourced QC data.

Nice To Haves

Quality control experience working within rare and/or ultra-rare disease development models, including lean organizations, accelerated timelines, and high reliance on outsourced partners, is a strong asset.
Experience applying digital, automation, and/or AI-enabled solutions within QC or CMC environments, such as analytical data review, trend analysis, stability modeling, data integrity monitoring, or outsourced partner performance management, is a strong asset.
Experience with biologics QC is considered an additional advantage, particularly for candidates supporting hybrid portfolios in a virtual QC model.

Responsibilities

Provide end-to-end QC oversight for a 100% outsourced operating model, supporting small molecule drug substance and drug product programs across clinical and commercial stages.
Provide technical and strategic leadership for small molecule QC, including solid oral dosage forms and sterile parenterals, with hands-on oversight of analytical testing, method validation, investigations (deviations, OOS), CAPAs, and lifecycle management in compliance with ICH/USP/Ph. Eur./JP requirements.
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.
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.
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.
Provide QC oversight or strategic input for biologics and/or oligonucleotide programs, including analytical methods, stability, and regulatory interactions, as needed.
Lead selection, qualification, onboarding, and ongoing performance management of contract laboratories and QC service providers, including governance models, KPIs, and issue escalation.
Act as the QC representative in cross-functional CMC teams, collaborating closely with Technical Operations, Analytical Development, QA, Regulatory Affairs, Supply Chain, and Program Management.
Lead QC support for regulatory inspections and audits involving CMOs and CLs; author and manage responses to QC-related observations and commitments.