Director, Purification Process Development
Apply NowCompany: Ultragenyx Pharmaceutical
Location: Woburn, MA 01801
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:
ultradedicated - Your biggest challenges yield rare possibilities
The Director of Purification Process Development will provide strategic leadership to the Purification Process Development team, leveraging subject matter expertise to support the development of robust, innovative purification processes and providing strategic guidance to the implementation of new and improved technologies for early and late-stage manufacturing activities. Reporting to the Senior Director of Pharmaceutical Development, the incumbent will work collaboratively with process and analytical development leads to align strategy, development, and technology implementation. A critical function of this role will include strategic leadership supporting the delivery of CMC milestones to advance development of AAV gene therapy vector products.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.
Responsibilities:
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
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: [redacted].
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 Director of Purification Process Development will provide strategic leadership to the Purification Process Development team, leveraging subject matter expertise to support the development of robust, innovative purification processes and providing strategic guidance to the implementation of new and improved technologies for early and late-stage manufacturing activities. Reporting to the Senior Director of Pharmaceutical Development, the incumbent will work collaboratively with process and analytical development leads to align strategy, development, and technology implementation. A critical function of this role will include strategic leadership supporting the delivery of CMC milestones to advance development of AAV gene therapy vector products.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.
Responsibilities:
- Work collaboratively with process development leadership to build scalable AAV production platforms, including next-generation platforms, to support Ultragenyx Gene Therapy's multi-product portfolio of clinical development programs.
- Develop, optimize, and characterize robust purification production processes and process technology.
- Provide scientific leadership on transfer and implementation of new technologies to ensure timely and efficient implementation to manufacturing.
- Work across Development, Manufacturing, Regulatory Affairs, and Quality functions to ensure development, manufacturing, and CMC Regulatory activities are scheduled in accordance with Program Core Team timelines and executed on time according to plan.
- Provide strategic leadership and influence for the development and tech transfer of process platforms to support manufacturing of AAV gene therapy products across a network of internal and external manufacturing sites.
- Develop phase appropriate process development strategy through process validation and global regulatory submissions.
- Represent Pharmaceutical Development at cross-functional program and strategy meetings.
- Develop and lead a group of scientists through direct supervision or as matrix leader.
- Author and review regulatory submissions and responses to questions from health authorities.
- BS, MS, or PhD in Chemical Engineering or Biological/Biochemical sciences.
- Minimum 12 years (BS), 10 years (MS), 7 years (PhD) of relevant biopharmaceutical industry experience.
- Demonstrated experience leading purification development initiatives in support of viral vector, vaccine, or protein biologics manufacturing.
- In-depth technical understanding of early- and late-stage process characterization and process validation to support GMP manufacturing of viral vectors, vaccines, or protein biologics.
- Proficiency in strategic planning, team dynamic management, and technical leadership.
- Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a fast-paced environment.
- Ability to influence others using collaboration, team building, communication, and strong organizational skills are required.
- Excellent written and verbal communication skills.
- Prior CMC leadership experience a plus.
- Can do attitude that sees challenges as opportunities.
- Demonstrated ability to influence scientific and business strategies and decisions.
- Travel: < 5% #LI-CS1 #LI-Onsite
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
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: [redacted].