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 Senior Director Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyxs drug product formulations including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities supports reliable clinical and commercial supply and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partnerscrossfunctionallyacross Quality Regulatory Supply Chain and Development organizations.
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 external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment.
- Oversee production planning execution and performance tracking to ensure clinical and commercial supply commitments are met.
- Manage CMO relationships includingselection onboarding and performance management fostering strong collaborative partnerships.
- Lead or support CMC activities across the drug product portfolio including authoring and reviewing CMC sections for global regulatory filings (INDs IMPDs NDAs MAAs).
- Serve as an integral member of crossfunctional CMC teams partnering with Quality Regulatory Supply Chain Development and Clinical teams.
- Develop andmaintainmanufacturing documentation including Product Design History Files and Quality Risk Management Plans.
- Oversee process development technology transfer process optimization and lifecycle management activities.
- Manage manufacturing-related deviations change controls investigations and complaint responses.
- Drive RFPs Statements of Work Master Service Agreements and other manufacturing governance documents.
- Promote knowledge management documentation best practices continuous improvement and operational excellence initiatives whilerepresentingDrug Product Manufacturing on global and crossfunctional teams.
Requirements:
- PhD or equivalent relevant experience in Pharmaceutical Sciences Engineering or related discipline.
- 1015 years of experience in pharmaceutical or biopharmaceutical manufacturing preferably within global organizations.
- Demonstratedexpertisein small molecule drug product development and clinical/commercialmanufacturing;experience with multiple dosage forms preferred.
- Strong knowledge ofQbD DoE process validation/qualificationphaseappropriate manufacturingcontrols PAT and current regulatory expectations for drug products.
- Working knowledge of cGMP ICH guidelines and global regulatory submission requirements.
- Proventrack recordmanaging and sustaining effective CMO partnerships in a matrixed organization.
- Experience with analytical development and quality control is a plus.
- Strong problemsolving leadership communication and financial acumen.
- Commitment to coaching feedback and continuous learning and development.
Physical Demand Requirements
Officebased role with occasional presence in manufacturing and partner facilities. requiringGxPgowning and wear protective clothing over the head face hands feet and body may berequiredduring site visits or when attending as person-in-plant. This requires the ability to change clothes intoappropriate gowningand 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
$251300 - $310500 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:
Exec
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 Senior Director Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyxs drug product formulations including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities supports reliable clinical and commercial supply and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partnerscrossfunctionallyacross Quality Regulatory Supply Chain and Development organizations.
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 external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment.
- Oversee production planning execution and performance tracking to ensure clinical and commercial supply commitments are met.
- Manage CMO relationships includingselection onboarding and performance management fostering strong collaborative partnerships.
- Lead or support CMC activities across the drug product portfolio including authoring and reviewing CMC sections for global regulatory filings (INDs IMPDs NDAs MAAs).
- Serve as an integral member of crossfunctional CMC teams partnering with Quality Regulatory Supply Chain Development and Clinical teams.
- Develop andmaintainmanufacturing documentation including Product Design History Files and Quality Risk Management Plans.
- Oversee process development technology transfer process optimization and lifecycle management activities.
- Manage manufacturing-related deviations change controls investigations and complaint responses.
- Drive RFPs Statements of Work Master Service Agreements and other manufacturing governance documents.
- Promote knowledge management documentation best practices continuous improvement and operational excellence initiatives whilerepresentingDrug Product Manufacturing on global and crossfunctional teams.
Requirements:
- PhD or equivalent relevant experience in Pharmaceutical Sciences Engineering or related discipline.
- 1015 years of experience in pharmaceutical or biopharmaceutical manufacturing preferably within global organizations.
- Demonstratedexpertisein small molecule drug product development and clinical/commercialmanufacturing;experience with multiple dosage forms preferred.
- Strong knowledge ofQbD DoE process validation/qualificationphaseappropriate manufacturingcontrols PAT and current regulatory expectations for drug products.
- Working knowledge of cGMP ICH guidelines and global regulatory submission requirements.
- Proventrack recordmanaging and sustaining effective CMO partnerships in a matrixed organization.
- Experience with analytical development and quality control is a plus.
- Strong problemsolving leadership communication and financial acumen.
- Commitment to coaching feedback and continuous learning and development.
Physical Demand Requirements
Officebased role with occasional presence in manufacturing and partner facilities. requiringGxPgowning and wear protective clothing over the head face hands feet and body may berequiredduring site visits or when attending as person-in-plant. This requires the ability to change clothes intoappropriate gowningand 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
$251300 - $310500 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:
Exec
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