Associate Director, Biologics Manufacturing Management
Somerville, MA · United States - Remote
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 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.
Or
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:
- Oversee external manufacturing of biologics drug substance manufacturing and aseptic drug product manufacturing for biologics and oligonucleotides.
- Support Biologics CMC strategy, milestones and goals with input from the key stakeholders, such as the CMC Review …
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Flexible work model Growth Opportunities Inclusive environment Supportive culture
Tasks- Drive process optimization
- Ensure compliance with regulations
Collaboration Communication Compliance Contract Negotiation Cross-Functional Team Collaboration Management Problem-solving Process Optimization Project Management Quality Assurance Quality Control Regulatory Affairs Regulatory Compliance Reimbursement Risk Management Technical Expertise
Experience10 years
EducationBioengineering Biological Sciences B.S. Business DO Engineering Pharmaceutical Sciences
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9