Ultragenyxpharmaceutical
Associate Director, Biologics Manufacturing Management
Company
Role
Associate Director, Biologics Manufacturing Management
Location
Job type
-
Posted
3 hours ago
Salary
Job description
Position Summary:
ultrainnovative – Tackle rare and dynamic challenges
You will provide technical expertise for critical starting materials, drug substance, and/or drug product manufacturing over the life cycle of the products in the Ultragenyx biologics/gene therapy portfolio from development through commercialization. You will serve as external manufacturing relationship manager at the respective contract manufacturing organizations (CMOs) and represent manufacturing as part of cross-functional Ultragenyx CMC teams.
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:
- Oversee external manufacturing of plasmid DNA, biologics and gene therapy drug substance, as well as aseptic drug product manufacturing for biologics and oligonucleotides.
- Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans.
- Lead relationships with CMOs and foster collaborative partnership.
- Participate in Health Authority interactions as a subject matter expert.
- Author global CMC filings in accordance with applicable regulations and guidance.
- Identify and enable selection of DS and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit.
- Actively identify and manage product or manufacturing process risks.
- Manage process optimization, tech transfer, and change control.
- Drive troubleshooting and quality deviation investigations occurring at manufacturing sites.
- Direct key business agreements, manage budget & cost control, approve purchase orders & invoices, and improve COGS development.
Requirements:
- BS in Pharmaceutical, Biological or Bioengineering Sciences or Engineering.
- 10+ years of relevant combined experience in Process Development, MSAT, Quality Assurance, or Manufacturing in biotech / pharmaceutical industry. Fewer years are acceptable if combined with relevant advanced degree.
- Technical experience in process development and commercial bioprocess manufacturing, including one or more of plasmid DNA, enzymes, antibodies, gene therapies, or aseptic drug product manufacturing.
- Substantial experience working in an outsourcing model, involving CMO/CDMO management.
- Proficient in cGMPs and pharmaceutical industry procedures and regulations.
- Good understanding of financial figures, cost management and financial decision making.
- Strong collaboration, communication skills and drive for results.
- Excellent problem-solving skills and verbal/written communication skills.
- Ability to support work requirements across multiple Ultragenyx time zones and reflective of 24/7 manufacturing schedules at CMO sites, as applicable.
- Up to 25% travel commitments (domestic and international) and occasional person-in-plant activities.
#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 applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
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 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.
