Senior Director, Upstream Process Development

5 days ago

Brisbane, Queensland, Australia Ultragenyx Pharmaceutical Inc. Full time
Senior Director, Upstream Process Development

Brisbane, CA

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.

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.
  • Long term incentive and Employee stock purchase plans or equivalent offerings.
  • Fitness reimbursement.

* 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.

#J-18808-Ljbffr

  • Director of Upstream Process Innovation

    5 days ago

    Brisbane, Queensland, Australia Ultragenyx Pharmaceutical Inc. Full time

    SynopsisUltragenyx Pharmaceutical Inc. is seeking a highly skilled and experienced individual to lead the development of upstream process development for late-stage pipeline products.Key Responsibilities:Develop and implement strategies for upstream process development, aligning with global CMC development goals and priorities.Lead the development of cell...

  • Senior Director for Biologics Development

    5 days ago

    Brisbane, Queensland, Australia Ultragenyx Pharmaceutical Inc. Full time

    About the RoleThe Senior Director for Biologics Development will be responsible for leading the development of upstream process development for late-stage pipeline products at Ultragenyx Pharmaceutical Inc.Main Objectives:Develop and execute strategic plans for upstream process development, ensuring alignment with global CMC development goals and...

  • Upstream Technical Development Expert

    5 days ago

    Brisbane, Queensland, Australia Ultragenyx Pharmaceutical Inc. Full time

    About the PositionThe Upstream Technical Development Expert will be responsible for leading the development of upstream process development for late-stage pipeline products at Ultragenyx Pharmaceutical Inc.Main Objectives:Develop and execute strategic plans for upstream process development, ensuring alignment with global CMC development goals and...

  • Manager, Upstream Processing

    5 days ago

    Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear...

  • Process Development Leader for Late-Stage Assets

    5 days ago

    Brisbane, Queensland, Australia Ultragenyx Pharmaceutical Inc. Full time

    Job DescriptionWe are seeking an experienced Process Development Leader to join our team at Ultragenyx Pharmaceutical Inc.Main Responsibilities:Develop and implement upstream process development strategies, ensuring alignment with global CMC development goals and priorities.Lead the development of mammalian and microbial process development to support...

  • Upstream Operations Expert

    5 days ago

    Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

    About the JobThis Upstream Process Manager position has become available due to internal movement and is essential for supporting the balanced growth of our Operations group. You will have the opportunity to showcase your leadership strengths, guiding your team through the next phase of our evolution.What We OfferWe provide a comprehensive benefits package...

  • Senior Federal Prosecutor

    4 days ago

    Brisbane, Queensland, Australia Director of Public Prosecution Full time

    Create a free Lawyers Weekly Jobs accountIn addition to the base salary and 15.4% superannuation, the Senior Federal Prosecutor (SFP) position attracts a $25,950 per annum allowance, in line with the Determination 2024-4 Prosecutor Allowance.The Office of the Director of Public Prosecutions (Cth) (CDPP) is looking for highly skilled, forward-thinking, and...

  • Process Engineer

    7 days ago

    Brisbane, Queensland, Australia Prudentia Process Consulting Full time

    As a Process Engineer, you will play an important role in delivering project design and support services to the diverse portfolio of projects in our Energy / Chemicals team. We are seeking outcome-focused individuals who are highly motivated, proactive, and thrive in a challenging, multi-disciplinary environment. The salary and level of responsibility for...

  • Process Design Specialist

    7 days ago

    Brisbane, Queensland, Australia Prudentia Process Consulting Full time

    As a Process Engineer at Prudentia Process Consulting, you will play a crucial role in delivering project design and support services to diverse projects in our Energy/Chemicals team. We are seeking outcome-focused individuals who are highly motivated, proactive, and thrive in challenging, multi-disciplinary environments.Key Responsibilities:Minimum of 3...

  • Product Development Director

    7 days ago

    Brisbane, Queensland, Australia Mineral Technologies Full time

    Join our dynamic team at Mineral Technologies in Carrara, QLD as a Product Development Director. As a leader in mineral processing equipment and modular processing plant design, we require experience in driving innovation and product development.About the CompanyWe are a forward-thinking organization committed to delivering cutting-edge solutions.Job...

  • Process Team Leader

    4 weeks ago

    Brisbane, Queensland, Australia Santos Limited Full time

    Location: Brisbane Ref#: ATR 500862 Description & Requirements About Us Santos provides reliable, affordable energy for progress and seeks to provide lower carbon energy over time.Santos is a global energy company with operations across Australia, Papua New Guinea, Timor-Leste and the United States.At Santos, our goal is to be a global leader in the energy...

  • Senior Director, Planning

    9 hours ago

    Brisbane, Queensland, Australia Foot Locker, Inc. Full time

    Overview (Text Only)Foot Locker is on a mission to unlock the inner sneakerhead in all of us The Senior Director, Planning & Allocations, FL APAC is a key member of the FL APAC Senior Leadership Team, holding overall responsibility for the effective management of the product planning and allocations functions.The Planning & Allocations Department provides...

  • Senior SMP Designer

    3 days ago

    Brisbane, Queensland, Australia Prudentia Process Consulting Full time

    Add expected salary to your profile for insightsEstablished in 2014, Sedgman Prudentia delivers multi-discipline engineering services across all phases of projects from research and development, piloting, option selection or optimisation studies, feasibility studies, front-end engineering and detailed design, project implementation, operational readiness and...

  • Process Improvement Director

    4 days ago

    Brisbane, Queensland, Australia Waters Corporation Full time

    Commercial Excellence StrategistThis is an exciting opportunity to join our Center for Process Excellence team as a Sr Director, Global Process Owner – Commercial. The successful candidate will drive transformative improvements in strategic and tactical sales and marketing processes and systems, accelerating revenue growth and improving efficiency and...

  • Senior Director, National Accounts

    3 weeks ago

    Brisbane, Queensland, Australia Vera Therapeutics, Inc. Full time

    Title: Senior Director, National Accounts Location: Brisbane, CA/Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for...

  • Senior Process Engineer- Gas Processing

    3 weeks ago

    Brisbane, Queensland, Australia Mining3 Full time

    Mining3 is dedicated to transforming the mining industry by collaborating with partners to accelerate the deployment of innovative solutions.Our programs develop into world-class solutions to industry challenges, with a focus on safety, cost reduction and sustainability through Technology.About the Role: This is a full-time Senior Process Engineer – (Gas...

  • Senior and Principal Planners

    1 week ago

    Brisbane, Queensland, Australia Department of State Development, Infrastructure and Planning Full time

    Be among the first 25 applicants.Human Centred Executive Leader, Board Member, General Manager, Strategic Policy, Projects and Operational ImprovementMultiple Director roles available.Seniority LevelDirectorEmployment TypeFull-timeJob FunctionOtherIndustriesGovernment AdministrationGet notified about new Principal Planner jobs in Brisbane, Queensland,...

  • Prosecutor Leader

    4 days ago

    Brisbane, Queensland, Australia Director of Public Prosecution Full time

    The Office of the Director of Public Prosecutions (Cth) is looking for a highly skilled and experienced Senior Federal Prosecutor to join its team. As a Senior Federal Prosecutor, you will be responsible for utilising cutting-edge technology, applying relevant legislation and policy, and exercising judgment to make legal decisions and recommendations.About...

  • Federal Prosecution Specialist

    4 days ago

    Brisbane, Queensland, Australia Director of Public Prosecution Full time

    The Director of Public Prosecutions (DPP) is seeking a highly skilled and forward-thinking Senior Federal Prosecutor to join its team. This exciting opportunity allows you to utilise cutting-edge technology, apply relevant legislation and policy, and exercise judgment to make legal decisions and recommendations.About the Role:As a Senior Federal Prosecutor,...

  • Senior Contract Professional

    6 days ago

    Brisbane, Queensland, Australia H-E Parts Full time

    OverviewH-E Parts is seeking a seasoned Senior Contract Professional to lead the delivery of complex commercial projects. This role requires an individual with exceptional negotiation skills, strong analytical abilities, and experience in managing contractual relationships.About the RoleThis position involves working closely with project managers to ensure...