Director, Oligonucleotide Process Development
Scorpion Therapeutics, Brisbane, CA, United States
Position Summary:
ultra impact – Make a difference for those who need it most
The Director of Oligonucleotide Process Development provides 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 from pre-IND through NDA submission and 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 of cGMP requirements, CMC control strategies, and global regulatory expectations. The Director operates with a high degree of autonomy, manages complex external partnerships, and is accountable for technical execution, risk mitigation, and regulatory readiness.
Pay Range: $219,200 – $270,800 USD.
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 drug substance process development, optimization, scaleup, technology transfer, process characterization, validation, and manufacturing support for
ASO, siRNA, and small molecule programs
within Ultragenyx’s pipeline.
Provide technical leadership and expert oversight for oligonucleotide (ASO) process development and manufacturing activities conducted at
CROs, CMOs, and CDMOs .
Serve as a core technical contributor within cross‑functional
CMC project teams , driving execution of program milestones on schedule and within budget.
Lead or actively participate in the
selection, evaluation, and governance
of external partners, ensuring delivery of high‑quality, compliant work packages.
Author, review, and approve drug substance–related sections of
IND, IMPD, NDA, and MAA
submissions.
Support Manufacturing, Quality, and Supply Chain teams in
deviation investigations, root cause analysis, change management, and product lifecycle activities .
Act as a technical subject‑matter expert 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 to establish and maintain
MSAs 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 supporting
batch disposition and release decisions . Support resolution of manufacturing deviations and events.
Ensure all activities are conducted in compliance with
internal 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, including
route scouting, process research and development (PRD), scaleup, and nGMP/GMP manufacturing .
Requirements:
PhD
in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline with
10+ years
of relevant pharmaceutical industry experience;
or
MS with
12+ years ;
or
BS with
15+ years , including demonstrated technical or matrix leadership experience.
Minimum
8 years
of experience in oligonucleotide drug substance development, including large‑scale synthesis and purification.
Proven track record in ASO
process development, manufacturing, technology transfer
and end‑to‑end
ownership of the DS control strategy .
Strong working knowledge of
IND/IMPD/NDA/MAA
submissions and global regulatory and quality requirements, including
ICH guidelines .
Extensive experience selecting, managing, and collaborating with
CROs/CMOs/CDMOs
in an outsourced development environment.
Demonstrated ability to lead complex, cross‑functional technical initiatives and manage multiple external partners concurrently.
Strong problem‑solving skills with excellent written and verbal communication abilities.
Experience applying
Design of Experiments (DoE)
and statistical tools to process development and optimization.
Experience supporting both early‑stage and latest‑stage drug substance development, including GMP manufacturing.
Willingness to travel up to
15% .
Physical Demand Requirements:
Sitting and standing for extended periods of time with periodic stooping / bending / kneeling.
Able to lift, push, pull up to 25 lbs.
Climb ladders and stairs of various heights.
Domestic and international travel up to 15%.
Benefits:
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 sponsorship.
Professional development plans.
See our CCPA Employee and Applicant Privacy Notice.
See our Privacy Policy.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, 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 at talentacquisition@ultragenyx.com.
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.
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The Director of Oligonucleotide Process Development provides 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 from pre-IND through NDA submission and 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 of cGMP requirements, CMC control strategies, and global regulatory expectations. The Director operates with a high degree of autonomy, manages complex external partnerships, and is accountable for technical execution, risk mitigation, and regulatory readiness.
Pay Range: $219,200 – $270,800 USD.
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 drug substance process development, optimization, scaleup, technology transfer, process characterization, validation, and manufacturing support for
ASO, siRNA, and small molecule programs
within Ultragenyx’s pipeline.
Provide technical leadership and expert oversight for oligonucleotide (ASO) process development and manufacturing activities conducted at
CROs, CMOs, and CDMOs .
Serve as a core technical contributor within cross‑functional
CMC project teams , driving execution of program milestones on schedule and within budget.
Lead or actively participate in the
selection, evaluation, and governance
of external partners, ensuring delivery of high‑quality, compliant work packages.
Author, review, and approve drug substance–related sections of
IND, IMPD, NDA, and MAA
submissions.
Support Manufacturing, Quality, and Supply Chain teams in
deviation investigations, root cause analysis, change management, and product lifecycle activities .
Act as a technical subject‑matter expert 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 to establish and maintain
MSAs 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 supporting
batch disposition and release decisions . Support resolution of manufacturing deviations and events.
Ensure all activities are conducted in compliance with
internal 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, including
route scouting, process research and development (PRD), scaleup, and nGMP/GMP manufacturing .
Requirements:
PhD
in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline with
10+ years
of relevant pharmaceutical industry experience;
or
MS with
12+ years ;
or
BS with
15+ years , including demonstrated technical or matrix leadership experience.
Minimum
8 years
of experience in oligonucleotide drug substance development, including large‑scale synthesis and purification.
Proven track record in ASO
process development, manufacturing, technology transfer
and end‑to‑end
ownership of the DS control strategy .
Strong working knowledge of
IND/IMPD/NDA/MAA
submissions and global regulatory and quality requirements, including
ICH guidelines .
Extensive experience selecting, managing, and collaborating with
CROs/CMOs/CDMOs
in an outsourced development environment.
Demonstrated ability to lead complex, cross‑functional technical initiatives and manage multiple external partners concurrently.
Strong problem‑solving skills with excellent written and verbal communication abilities.
Experience applying
Design of Experiments (DoE)
and statistical tools to process development and optimization.
Experience supporting both early‑stage and latest‑stage drug substance development, including GMP manufacturing.
Willingness to travel up to
15% .
Physical Demand Requirements:
Sitting and standing for extended periods of time with periodic stooping / bending / kneeling.
Able to lift, push, pull up to 25 lbs.
Climb ladders and stairs of various heights.
Domestic and international travel up to 15%.
Benefits:
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 sponsorship.
Professional development plans.
See our CCPA Employee and Applicant Privacy Notice.
See our Privacy Policy.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, 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 at talentacquisition@ultragenyx.com.
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.
#J-18808-Ljbffr