Principal Scientist, Biologics
J
JobgetherBiologics development
Based in the United StatesFull-TimePrincipal
Salary not disclosed
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Job Details
- Experience
- Bachelor's degree: 11 years of relevant experience. Master's degree: 9 years of relevant experience. PhD: 8 years of relevant experience. At least 5 years of experience in GMP environments, quality management systems, and CMC compliance.
- Required Skills
- Project Management
Requirements
- Hold a degree in science or engineering.
- Have at least 11 years of relevant experience with a bachelor's degree, 9 years with a master's degree, or 8 years with a PhD.
- Have at least 5 years of experience in GMP environments, quality management systems, and CMC compliance.
- Bring technical knowledge in one or more biologics development areas: analytical sciences, purification, formulation, or bioconjugation.
- Demonstrate project management experience in planning, coordination, risk assessment, and delivery management.
- Have experience supporting process development, technology transfer, analytical method transfer, clinical manufacturing, or regulatory documentation.
- Work effectively in cross-functional and virtual teams, manage competing priorities, and complete assignments independently.
- Communicate and collaborate effectively with stakeholders, including in formal meetings and discussions with external partners.
- Be willing to travel approximately 10–25% for in-person meetings, partner-site visits, and technical support at manufacturing sites.
Responsibilities
- Lead biologics development projects to characterize, optimize, and qualify processes for clinical drug substance intermediates.
- Lead process development across analytical sciences, purification, formulation, and bioconjugation.
- Develop process knowledge, transfer technology and analytical methods, define design spaces and control strategies, and optimize and qualify processes.
- Review and approve standard operating procedures, batch records, protocols, analytical procedures, and technical development reports.
- Maintain GMP and quality-system compliance through documentation, quality investigations, corrective and preventive actions, and change control.
- Author and review source documents and CMC content for IND, NDA, and BLA regulatory submissions.
- Lead work with internal sites and external CMC partners, coordinating development, troubleshooting challenges, and managing deliverables.
- Conduct risk assessments and monitor project performance, timelines, and program objectives.
- Serve as biologics technical lead for an assigned therapeutic program and communicate with cross-functional teams and third-party stakeholders.
- Mentor Senior Scientists and other scientists, providing technical guidance.
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