Senior Director, Upstream Process Development at Ultragenyx in BRISBANE, California

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:

ultrainnovative - Tackle rare and dynamic challenges

This position seeks a highly motivated and experienced technical leader to lead the development of upstream process development for Ultragenyx pipeline products, including proteins, antibodies, therapeutic messenger RNAs and AAV-based gene therapy products. This position reports to the VP, Technical Development and will interact with all levels across the company organizations. He/she will be part of the Technology Development team, Global CMC Development and will lead key program development activities internally as well as at external CDMOs. He/she will provide strategic direction, technical expertise, and tactical oversight for activities in upstream process development for late-stage and commercial stage programs.

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:

• Lead BLA enabling development of a late-stage antibody asset via external manufacturing.


• Manage a complex technology transfer, troubleshoot manufacturing deviations, and author PAS to ensure global access for the antibody asset.


• Establish external and internal upstream process development strategies in alignment with Global CMC Development, program teams, and CMC subteams goals and priorities.


• Lead upstream process development including cell culture process development, tech transfer and scale up, process characterization and validation of biologics and enzymes.


• Lead the mammalian and microbial process development to support development, non-GMP production, and troubleshooting of GMP manufacturing.


• Lead external development at CDMOs, manage communications, contracts, timelines and budget, oversee tech transfer, process improvement, and investigation in support of GMP manufacturing and product supply.


• Collaborate effectively cross-functionally and cross-company with external partners, downstream, analytical, manufacturing, quality etc. to deliver project milestones on time and within budget.


• Build and manage upstream team to achieve consistently positive results, including but not limited to, recruiting, mentoring and managing in-house team.


• Author and review SOPs, technical reports, IRs and relevant sections of regulatory IND/BLA/MAA fillings and interacts with global regulatory agencies.


• Follow all safety and compliance regulations and company policies at work.

Requirements:

• PhD in Chemical Engineering, Biochemistry, or related field with minimum 10+ years of relevant working experience, or MS with minimum 12 years, or BS with minimum 15 years with 5+ years of leadership experience


• Must have hands-on experience in Upstream Process Development of biologics, MSAT, Manufacturing and/or Engineering in biotech/pharmaceutical industry


• Proven track record of accomplishments in the design, development, and validation of clinical and/or commercial stage biologics manufacturing processes, with emphasis on upstream process development.


• Strong track record of successful IND/IMPD/BLA/MAA filing and familiarity with quality and regulatory requirements of large molecule products including ICH guidelines.


• Significant experience working in an outsourcing environment. GMP manufacturing experience is preferred.


• Strong interpersonal skills and the ability to lead the team managing in-house USP team and effort.


• Must have excellent problem-solving skills with proven ability to work autonomously and manage effectively in a matrix environment.


• High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.


• Must be willing to travel 10% of time. #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$251,500—$310,700 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.

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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-9e7d6574-c387-4578-8b27-63843a040dc7 Apply Now