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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 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 andpersonally come join our team.
Position Summary:
ultraimpact Make a difference for those who need it most
TheDirectorofOligonucleotide Process Developmentprovides independent technical leadership for oligonucleotide and small molecule drug substance development activities including process development scaleup technology transfer and GMP manufacturing. The role supports multiple development programs frompreINDthrough NDAsubmissionand serves as a core member of CMC program teams.
This position requires deep expertise in oligonucleotide and small molecule synthesis purification technologies and analytical methods along with a strong understanding ofcGMP requirements CMC control strategies and global regulatory expectations. The Directoroperateswith a high degree of autonomy manages complex external partnerships and is accountable for technical execution risk mitigation and regulatory readiness.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Lead drug substance process development optimization scaleup technology transfer process characterization validation and manufacturing support forASO siRNA andsmallmoleculeprogramswithin Ultragenyxs pipeline.
- Provide technical leadership and expert oversight for oligonucleotide (ASO) process development and manufacturing activities conducted atCROs CMOs and CDMOs.
- Serve as a core technical contributor withincrossfunctionalCMC project teams driving execution of program milestones on schedule and within budget.
- Lead or activelyparticipatein theselection evaluation and governanceof external partners ensuring delivery ofhighquality compliant work packages.
- Author review and approve drug substancerelated sections ofIND IMPD NDA andMAAsubmissions.
- Support Manufacturing Quality and Supply Chain teams indeviation investigationsrootcauseanalysis change management and product lifecycle activities.
- Act as a technicalsubjectmatterexpert for Research and Business Development initiatives including technical assessments and due diligence support as needed.
- Prepare and manage program budgets; develop and issue RFPs; review and approve work orders; and partner with Legal and Quality toestablishand maintainMSAs and QTAs.
- Draft review and approve drug substance technical documentation including process development reports master batch records campaign reports validation documentation and change controls.
- Oversee review of executed batch records and provide technical input supportingbatch disposition and release decisions.Supportresolution of manufacturing deviations and events.
- Ensure all activities are conducted in compliance withinternal policies cGMP requirements and applicable global regulatory standards and guidelines. Maintain current knowledge of relevant pharmaceutical regulations.
- Manage all ASO regulatory starting material and drug substance development activities conducted internally and at external CDMO partners includingroute scouting processresearchand development (PRD) scaleup andnGMP/GMP manufacturing.
Requirements:
- PhDin Chemistry Chemical Engineering Pharmaceutical Sciences or a related discipline with10 yearsof relevant pharmaceutical industry experience;orMS with12 years;orBS with15 years includingdemonstratedtechnical or matrix leadership experience.
- Minimum8 yearsof experience in oligonucleotide drug substance development including largescale synthesis and purification.
- Proventrack recordin ASOprocess development manufacturing technology transfer and end-to-endownership of the DS control strategy.
- Strong working knowledge ofIND/IMPD/NDA/MAAsubmissions and global regulatory and quality requirements includingICH guidelines.
- Extensive experience selecting managing and collaborating withCROs/CMOs/CDMOsin an outsourced development environment.
- Demonstrated ability to lead complexcrossfunctionaltechnical initiatives and manage multiple external partners concurrently.
- Strongproblemsolvingskills with excellent written and verbal communication abilities.
- Experience inapplyingDesign of Experiments (DoE)and statistical tools to process development and optimization.
- Experience supporting bothearlystageandlatestagedrug substance development including GMP manufacturing.
- Willingness to travel up to15%.
Physical Demand Requirements
- Sitting andtand for extended periods of time with periodic stooping / bending / kneeling
- Able to lift push pull up to25lbs.
- Climb ladders and stairs of various heights.
- Domestic and international travel up to15%
#LI-CT1#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 applicants 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
$219200 - $270800 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 .
See ourCCPA 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:.
Required Experience:
Director
Why Join UsBe a hero for our rare disease patientsAt 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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 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 andpersonally come join our team.
Position Summary:
ultraimpact Make a difference for those who need it most
TheDirectorofOligonucleotide Process Developmentprovides independent technical leadership for oligonucleotide and small molecule drug substance development activities including process development scaleup technology transfer and GMP manufacturing. The role supports multiple development programs frompreINDthrough NDAsubmissionand serves as a core member of CMC program teams.
This position requires deep expertise in oligonucleotide and small molecule synthesis purification technologies and analytical methods along with a strong understanding ofcGMP requirements CMC control strategies and global regulatory expectations. The Directoroperateswith a high degree of autonomy manages complex external partnerships and is accountable for technical execution risk mitigation and regulatory readiness.
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Lead drug substance process development optimization scaleup technology transfer process characterization validation and manufacturing support forASO siRNA andsmallmoleculeprogramswithin Ultragenyxs pipeline.
- Provide technical leadership and expert oversight for oligonucleotide (ASO) process development and manufacturing activities conducted atCROs CMOs and CDMOs.
- Serve as a core technical contributor withincrossfunctionalCMC project teams driving execution of program milestones on schedule and within budget.
- Lead or activelyparticipatein theselection evaluation and governanceof external partners ensuring delivery ofhighquality compliant work packages.
- Author review and approve drug substancerelated sections ofIND IMPD NDA andMAAsubmissions.
- Support Manufacturing Quality and Supply Chain teams indeviation investigationsrootcauseanalysis change management and product lifecycle activities.
- Act as a technicalsubjectmatterexpert for Research and Business Development initiatives including technical assessments and due diligence support as needed.
- Prepare and manage program budgets; develop and issue RFPs; review and approve work orders; and partner with Legal and Quality toestablishand maintainMSAs and QTAs.
- Draft review and approve drug substance technical documentation including process development reports master batch records campaign reports validation documentation and change controls.
- Oversee review of executed batch records and provide technical input supportingbatch disposition and release decisions.Supportresolution of manufacturing deviations and events.
- Ensure all activities are conducted in compliance withinternal policies cGMP requirements and applicable global regulatory standards and guidelines. Maintain current knowledge of relevant pharmaceutical regulations.
- Manage all ASO regulatory starting material and drug substance development activities conducted internally and at external CDMO partners includingroute scouting processresearchand development (PRD) scaleup andnGMP/GMP manufacturing.
Requirements:
- PhDin Chemistry Chemical Engineering Pharmaceutical Sciences or a related discipline with10 yearsof relevant pharmaceutical industry experience;orMS with12 years;orBS with15 years includingdemonstratedtechnical or matrix leadership experience.
- Minimum8 yearsof experience in oligonucleotide drug substance development including largescale synthesis and purification.
- Proventrack recordin ASOprocess development manufacturing technology transfer and end-to-endownership of the DS control strategy.
- Strong working knowledge ofIND/IMPD/NDA/MAAsubmissions and global regulatory and quality requirements includingICH guidelines.
- Extensive experience selecting managing and collaborating withCROs/CMOs/CDMOsin an outsourced development environment.
- Demonstrated ability to lead complexcrossfunctionaltechnical initiatives and manage multiple external partners concurrently.
- Strongproblemsolvingskills with excellent written and verbal communication abilities.
- Experience inapplyingDesign of Experiments (DoE)and statistical tools to process development and optimization.
- Experience supporting bothearlystageandlatestagedrug substance development including GMP manufacturing.
- Willingness to travel up to15%.
Physical Demand Requirements
- Sitting andtand for extended periods of time with periodic stooping / bending / kneeling
- Able to lift push pull up to25lbs.
- Climb ladders and stairs of various heights.
- Domestic and international travel up to15%
#LI-CT1#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 applicants 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
$219200 - $270800 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 .
See ourCCPA 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:.
Required Experience:
Director
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Posted on:
6 days ago
Vacancies:
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