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:
ultrafocused Work together to fearlessly uncover new possibilities
The Director Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyxs small molecule and oligonucleotide programs. This roleis responsible forexecution of departmental manufacturing strategies management of external CMOs and delivery of reliable clinical and commercial supply undercGMPconditions. The Director partners crossfunctionally to ensure safe compliant and efficient manufacturing whileoperatingwithin established functional strategies.
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 and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment supporting both clinical and commercial supply.
- Oversee production planning execution and performance tracking to ensure reliable fulfillment of agreed manufacturing services.
- Manage and strengthen CMO relationships includingselection onboarding governance and ongoing performance management.
- Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio ensuring alignment with development and supply strategies.
- Author and/or provide expert input into CMC sections for global regulatory filings including INDs IMPDs NDAs and MAAs.
- Serve as an integral member of crossfunctional and crossdiscipline CMC teams for programscontainingsynthetic components.
- Oversee process development optimization technology transfer and lifecycle management including change controls deviations and investigations.
- Ensure development and maintenance of manufacturing-related documentation including Design History Files and Quality Risk Management Plans.
- Drive RFPs Statements of Work Master Service Agreements and other manufacturing and quality governance documents.
- Promote continuous improvement knowledge management and operational excellence whilerepresentingDrug Substance Manufacturing on global and crossfunctional teams.
Requirements:
- Ph.D. in chemistry chemical engineering organic chemistry ora relateddiscipline or equivalent industry experience.
- 812 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing.
- Demonstratedexperienceinmanagingsmall molecule synthetic chemistry pharmaceutical CMC development process scaleup and cGMP manufacturing.
- Demonstratedexperiencemanagingandparticipatingin crossfunctional CMC teams.
- Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus.
- Familiarity withQbDprinciples DoE processscale-up andoptimization validation/qualification andphaseappropriate controls.
- Solid knowledge of cGMP requirements ICH guidelines and phaseappropriatecontrols..
- Familiarity with analytical development and quality control isadvantageous.
- Strongtrack recordof building and sustaining effective CMO partnerships.
- Demonstrated ability to lead teams manage complexity and deliver results in a matrixed environment.
- Excellent written and verbal communication skills in English;additionallanguages are a plus.
- Demonstrated commitment to leadership development coaching and continuous learning.
Physical Demand Requirements
Officebased role with occasional presence in manufacturing and partner GxP gowning and wear protective clothing over the head face hands feet and bodymay be requiredduring site visits or when attending as requires the ability to change clothes into appropriate gowning and personal protective equipment.
#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
$212800 - $262800 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:
ultrafocused Work together to fearlessly uncover new possibilities
The Director Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyxs small molecule and oligonucleotide programs. This roleis responsible forexecution of departmental manufacturing strategies management of external CMOs and delivery of reliable clinical and commercial supply undercGMPconditions. The Director partners crossfunctionally to ensure safe compliant and efficient manufacturing whileoperatingwithin established functional strategies.
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 and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment supporting both clinical and commercial supply.
- Oversee production planning execution and performance tracking to ensure reliable fulfillment of agreed manufacturing services.
- Manage and strengthen CMO relationships includingselection onboarding governance and ongoing performance management.
- Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio ensuring alignment with development and supply strategies.
- Author and/or provide expert input into CMC sections for global regulatory filings including INDs IMPDs NDAs and MAAs.
- Serve as an integral member of crossfunctional and crossdiscipline CMC teams for programscontainingsynthetic components.
- Oversee process development optimization technology transfer and lifecycle management including change controls deviations and investigations.
- Ensure development and maintenance of manufacturing-related documentation including Design History Files and Quality Risk Management Plans.
- Drive RFPs Statements of Work Master Service Agreements and other manufacturing and quality governance documents.
- Promote continuous improvement knowledge management and operational excellence whilerepresentingDrug Substance Manufacturing on global and crossfunctional teams.
Requirements:
- Ph.D. in chemistry chemical engineering organic chemistry ora relateddiscipline or equivalent industry experience.
- 812 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing.
- Demonstratedexperienceinmanagingsmall molecule synthetic chemistry pharmaceutical CMC development process scaleup and cGMP manufacturing.
- Demonstratedexperiencemanagingandparticipatingin crossfunctional CMC teams.
- Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus.
- Familiarity withQbDprinciples DoE processscale-up andoptimization validation/qualification andphaseappropriate controls.
- Solid knowledge of cGMP requirements ICH guidelines and phaseappropriatecontrols..
- Familiarity with analytical development and quality control isadvantageous.
- Strongtrack recordof building and sustaining effective CMO partnerships.
- Demonstrated ability to lead teams manage complexity and deliver results in a matrixed environment.
- Excellent written and verbal communication skills in English;additionallanguages are a plus.
- Demonstrated commitment to leadership development coaching and continuous learning.
Physical Demand Requirements
Officebased role with occasional presence in manufacturing and partner GxP gowning and wear protective clothing over the head face hands feet and bodymay be requiredduring site visits or when attending as requires the ability to change clothes into appropriate gowning and personal protective equipment.
#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
$212800 - $262800 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
View more
View less
Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
