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:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Director, Manufacturing Sciences and Technology will oversee the Drug Substance (DS) team, providing technical and program leadership for early- and late-phase AAV manufacturing processes at both internal and contract manufacturing facilities.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Establish and improve systems and procedures for Technology Transfer, Process Performance Qualification (PPQ) and Continued Process Verification (CPV) of AAV gene therapy programs.
• Lead a team to deliver technology transfers for the early and late phase AAV manufacturing processes at both internal and contract manufacturing facilities. Own process control strategy documents, facility fit, process change assessment, FMEA, tech transfer plan, campaign summary reports, investigation reports and other technical and risk assessment documents.
• Lead the DS PPQ teams, own process validation master plans, DS PPQ master plans, PPQ protocols and PPQ reports.
• Lead the CPV program, own CPV plans, interim reports and Annual Product Reviews (APRs) for commercial products. Lead cross-functional manufacturing data review meetings. Develop and drive lifecycle management of commercial products.
• Lead a CMC team or represent MSAT and manufacturing functions in a CMC team. Provide technical and strategic leadership to drive alignment of critical decisions and risk mitigations within CMC functions and ensure timely delivery of CMC milestones per established contract. 
• Leverage process expertise and Operational Excellence approaches to lead / support process/operational deviations and manufacturing investigations, provide product impact assessment or risk assessment, support root cause identifications and Corrective Action and Preventive Actions (CAPA).
• Stay current with the AAV manufacturing technology innovation, and drive implementation of process improvements targeted at reducing manufacturing costs and improving process yield/product quality throughout the lifecycle of the product.
• Author module 3 section of regulatory submissions (IND/IMPD/BLA/MAA) and respond to information requests by health authorities.
• Lead the tracking, execution, and close-out of process-related post-marketing regulatory commitments; represent MSAT in Change Review meetings.
• Manage and mentor junior MSAT team members.

Requirements:

• Ph.D. or master’s degree in science or equivalent with substantial experience in pharmaceutical industry
• 12+ years in life sciences industry. Biologics, Gene / Cell Therapy experience required
• Experience with IND and BLA regulatory authoring
• Advanced manufacturing and technical acumen in the early, late and commercial phases of biopharmaceutical development and manufacturing
• Understanding of relevant global regulation and phase appropriate GxP requirements
• Experience with regulatory inspections and writing investigations and product impact summaries that meet regulatory expectations
• Excellent verbal and written communication skills
• Ability to work independently and as part of a team
• Experienced in working in a matrix organization with ability to influence and drive decision-making with different stakeholders
• Six Sigma / Lean management background

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping/bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• Climb ladders and stairs of various heights.
• Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.
• Certain tasks may require use of a respirator; medical clearance will be required in advance. #LI-CS1 #LI-Onsite

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$224,100—$276,800 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 Privacy Policy.   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.PDN-9e12c7d4-b720-4d8d-a43e-68b6858bc53d