Director, CMC QC Small Molecules

Director, CMC QC Small Molecules at Ultragenyx Director, CMC QC Small Molecules at Ultragenyx in BRISBANE, California Posted in 1 day ago.

Type:

Full Time Job Description:

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 .

Position Summary:

ultra dedicated

• Your biggest challenges yield rare possibilities The Director, CMC Quality Control
• Small Molecules is responsible for providing technical and strategic oversight of all outsourced QC activities supporting Ultragenyx small molecule drug substance and drug product programs across development and commercialization.

This position reports to the Executive Director, CMCQC. The role leads QC governance for contract manufacturing organizations (CMOs), contract laboratories (CLs), and other external partners, ensuring compliant, phaseappropriate, and inspectionready execution. QC testing experience supporting rare and ultrarare disease development models-characterized by lean organizations, accelerated timelines, and high reliance on outsourced partners-is a strong asset. Experience with biologics QC is considered an additional advantage, particularly for candidates supporting hybrid portfolios in a virtual QC model.

Work Model:

Flex:

This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Outsourced QC Oversight Provide endtoend QC oversight for a 100% outsourced operating model, supporting small molecule drug substance and drug product programs across clinical and commercial stages. CMC QC Leadership

• Small Molecules Provide technical and strategic leadership for small molecule QC, including solid oral dosage forms and sterile parenterals, with handson oversight of analytical testing, method validation, investigations (deviations, OOS), CAPAs, and lifecycle management in compliance with ICH/USP/Ph.

Eur./JP requirements. Analytical & Contract Laboratory Oversight Perform technical review and approval of outsourced analytical data, method validation, stability programs, reference standards, specifications, and shelflife assignments, ensuring phaseappropriate 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. CrossFunctional & Regulatory Engagement Collaborate crossfunctionally and lead CMC QC contributions to regulatory submissions, inspections, and audits, including authoring and defending QC sections and managing responses to health authority observations. Oligonucleotide Biologics QC (Advantage)

• 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 crossfunctional 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 QCrelated observations and commitments.

Requirements:

Education & Experience 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. CMC QC Experience

• Small Molecules Minimum 5-8+ years of direct CMC QC experience supporting small molecule drug substance and drug product, including commercial assets.

Analytical Technical Expertise Demonstrated handson expertise with small molecule analytical techniques, including HPLC/UPLC, LCMS, GC, dissolution, Karl Fischer, particle size, residual solvents, impurity profiling, and compendial safety testing. Regulatory & Compliance Knowledge Strong working knowledge of ICH, FDA, EMA, USP, and Ph. Eur. requirements applicable to small molecule development and commercialization. Outsourced QC & Vendor Oversight Proven experience overseeing external QC laboratories, CMOs, and contract testing organizations, including technical governance and performance management. Regulatory Submissions & Inspections Experience supporting global regulatory submissions and health authority inspections, including defense of outsourced QC data. Rare & UltraRare Disease Experience (Asset) Quality control experience working within rare and/or ultrarare disease development models, including lean organizations, accelerated timelines, and high reliance on outsourced partners, is a strong asset. AI & Digital Enablement (Asset) Experience applying digital, automation, and/or AIenabled 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. #LI-CS1 #LI-Hybrid The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range$232,600—$287,400 USD 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 country Ultragenyx 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, and any other status or classification protected by applicable federal, state, and/or local laws.

Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. 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 emailing us at talentacquisition@ultragenyx.com . See our CCPA Employee and Applicant Privacy Notice . See our . It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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 : . VEVRAA Federal Contractor. We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state. PDN-a1c64668-a755-4c53-89a5-99e8dcd02bb2