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Principal Scientist, Biologics Research
Company | Neurocrine Biosciences |
Address | San Diego, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-28 |
Posted at | 10 months ago |
Who We Are
- Ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate
- Works collaboratively with internal staff and collaboration partners to generate project and cost proposals, timelines, and work plans by applying scientific knowledge and business expertise
- Performs other tasks and assignments as needed and specified by management
- Provides leadership for the activities associated with the development of processes relevant to viral vector/gene therapy products including all aspects of upstream process and the associated analytical development in a Research and Development environment
- Actively contributes to, and assures, the development of, and effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development projects from candidate nomination to clinical development and commercial manufacture
- Responsible for participating in the day-to-day operations of the project, including conducting and evaluating training for new or current team members and delegating tasks appropriately
- Takes a lead in decision-making processes within the project team by actively engaging in scientific and technical discussions
- Drives the additional process development activities to support development candidates and activities for timely IND, BLA and all relevant ex-US regulatory filings
- Prepares clear and concise technical reports, participates or leads project teams
- Identifies and resolves technical problems through scientific understanding, options assessment, and application of innovative solutions
- Provides support for the activities associated with the development of processes relevant to antibody products including all aspects of upstream production in a Research and Development environment
- Drives the development of upstream suspension-based platform processes for the generation of material as well as the early optimization studies, working with a downstream and analytical team for the characterization and release testing to support research, pre-clinical, and IND-enabling studies
- Executes on strategy, vision, and direction set by line management
- Collaborates with Research and Product Development to build the scientific knowledge, capabilities, and strategies in biotherapeutic, protein and gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization
- Proven expertise with single-use bioprocessing equipment and its application to gene therapy process development and GMP manufacturing preferred
- Ability to deliver results within defined budget, timing, and resources constraints. Awareness of impact(s) on other functional areas.
- PharmD or PhD in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and 4+ years of similar experience noted above
- Excellent verbal and written communication skills
- Expert level knowledge of HEK-based AAV based gene therapy products with a good understanding of manufacturing and testing/characterization methods required
- Demonstrated ability to complete technical assignments by supporting the design, execution and interpretation of complex experiments
- Ability to lead analytical method and upstream process development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs) is desired
- Expert level knowledge of mammalian cell culture and associated upstream development
- BA/BS in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and 8+ years of Biotechnology industry experience in upstream mammalian or insect cell culture technologies and theory. Proven experience in the scale-up and technology transfer from pilot plant to manufacturing with extensive mammalian cell culture experience. Upstream experience with writing regulatory documents to support filings (INDs/CTAs, Briefing Materials, and BLAs/MAAs). Cell culture, lab-scale and pilot scale bioreactor experience is required. Downstream progressively responsible experience in biologics, vaccines and/or gene therapy process development roles. Demonstrated and significant applied experience with technology transfer-in and transfer-out of gene therapy manufacturing process at all levels of development. Significant experience in laboratory operations, including budgeting, capital expense procurement and IQ/OQ, safety, and status reporting to Senior Management. Demonstrated ability to lead downstream process development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs). Demonstrated and significant experience with single-use bioprocessing equipment and its application to gene therapy process development and GMP manufacturing OR
- Self-motivated and comfortable working as part of a cross-functional teams, and an ability to meet timelines efficiently and productively
- Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines
- Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and 6+ years of similar experience noted above OR
- Knowledge of CHO-based antibody expression system optimization is a plus
- Knowledge of GLP and GMP environments as they pertain to gene therapy process development and Quality Control (QC) testing
- Advanced planning, organization and time management skills including the ability to support and prioritize multiple projects
- Knowledge and experience with novel methods in AAV characterization (e.g. ddPCR, DLS, AUC, NGS, etc.) is preferred
- Knowledge of cell-based methods associated with bioanalytical analytical method development (e.g. TCID50, Potency assay, viral transduction, and ELISA methods)
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- Expertise in laboratory operations, including budgeting, capital expense procurement and IQ/OQ, safety, and status reporting to Senior Management
- Ability to monitor on-going experiments and suggest alternatives or solutions
- Expert level knowledge of the biologics drug development process is recommended
- Advanced knowledge with Excel, Word, PowerPoint and other associated software used in the scientific field
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