Note: The job is a remote job and is open to candidates in USA. Sabin Vaccine Institute works to make vaccines more accessible, enable innovation, and expand immunization globally. The Senior Manager, CMC Technical Operations supports vaccine products from clinical development through validation, marketing authorization, and commercial lifecycle management, coordinating CMC activities across internal teams and external partners.
Responsibilities
- Serve as cross-functional matrix team member and support end-to-end integration of CMC efforts for vaccine candidates
- Collaborate with internal and external CMC functional areas to ensure successful execution of assigned CMC projects, and delivery of results on time and within budget
- Assist with development and manufacturing alliance management, product development and manufacturing strategy
- Provide expert technical guidance across all CMC elements (banking through drug product, including testing and release), both internally and externally, to ensure appropriate product and process development
- Facilitate communication to ensure alignment between Sabin and external partners
- Proactively identify and communicate programs risks and work with teams to mitigate as required. Support stakeholder communication and alignment
- Support authoring, review and data verification of Module 3 IND, BLA/MAA and associated regulatory submissions, including Information Request responses
- Collect information and prepare documentation as assigned to support future funding efforts
- Manage, create and review CMC and Quality Systems documentation as required
- Support the implementation and administration of Sabin governance and management systems (including resourcing, financial planning/analysis, and similar)
- Provide written and verbal updates and presentations to internal and external stakeholders
Skills
- Minimum bachelor's degree in biochemical engineering, analytical chemistry, pharmaceutical sciences, biochemistry, or a related engineering or pharmaceutical science field
- Minimum of 10+ years of direct experience with CMC product and process development
- Direct experience with CMC biotechnology product and process development
- Working knowledge of all CMC areas including cell line development and characterization, drug substance, drug product, formulation development, packaging and labeling, and analytics, including stability programs and specification setting and justification
- Working knowledge and understanding of current regulations and industry trends for vaccine/biotechnology product development, manufacture, and testing
- Strong and effective project management, problem solving and interpersonal skills
- Strong writing and presentation skills
- Direct experience and training in current good manufacturing practices (cGMP)
- Working knowledge of ICH guidelines and associated regional requirements (FDA, EMEA, MHRA and similar)
- Demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions and lead in a matrix environment
- Ability to work independently with minimal direct oversight
- Position may require up to 15% travel (USA and international) with notice
- Must demonstrate interest in furthering Sabin's mission
- Advanced degree highly desired
- Experience with matrix team leadership
- Experience with validation and commercialization of late stage (Phase 3) biopharmaceutical products, including BLA/MAA authoring and defense
- Knowledge of adenoviral vector manufacturing, development, characterization and validation
Benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Flexible spending accounts
- Flexible vacation leave
- Sick leave
- Short-term disability options
- Long-term disability options
- 10 federal holidays
- An end of the year winter break
- An employer matching 401(k) plan
Company Overview
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