Ultragenyx Pharmaceutical
Biopharmaceutical
Director,CMCQCSmallMolecules
“Director, CMC QC Small Molecules at Ultragenyx Pharmaceutical. Skills: CMC QC Small Molecules, Outsourced QC Oversight, Analytical Technical Expertise, Regulatory & Compliance Knowledge, Outsourced QC & Vendor Oversight, Regulatory Submissions & Inspections. 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”
What You'll Achieve.
Ensuring compliant, phase‑appropriate, and inspection‑ready execution; Support global regulatory submissions and health authority inspections
Industry & Context.
Investigations (deviations, OOS); CAPAs
Onsite work 2-3 days each week, or more depending on business needs
What They're Looking For.
Must Have
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, 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 Have
QC testing experience supporting rare and ultra‑rare disease development models—characterized by lean organizations, accelerated timelines, and high reliance on outsourced partners, Experience with biologics QC, Quality control experience working within rare and/or ultra‑rare disease development models, including lean organizations, accelerated timelines, and high reliance on outsourced partners, 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
What You'll Do.
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
investigations (deviations
and lifecycle management in compliance with ICH/USP/Ph. Eur. /JP requirements
Author and manage responses to QC‑related observations and commitments
How You'll Work.
Team & Collaboration
Leads QC governance for contract manufacturing organizations (CMOs), contract laboratories (CLs), and other external partners; Creating a collaborative ecosystem
Applying for this Director, CMC QC Small Molecules role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Ultragenyx Pharmaceutical?
Real rants from real employees. Read before you apply.