Sr. Scientist/Principal Scientist, CMC Downstream Gene Therapy Development

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Provides leadership for exploratory development of AAV gene therapy purification including all aspects of downstream process and the associated analytical development in a research & development environment

• Experienced in the development, implementation, and manufacturing of AAV drug substances for pre-clinical and clinical trial use

• Provides support for exploratory process development for therapeutic antibodies including all aspects of downstream production in a research environment

• Drives the implementation of downstream 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

• Drives the additional process development activities to support development candidates and activities for timely IND, BLA and all relevant ex-US regulatory filings

• Collaborates with discovery 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

• Actively contributes to science-driven, phase appropriate, and risk-based process development strategies to enable further development from candidate nomination to clinical development and commercial manufacture

• Identifies and resolves technical problems through scientific understanding, options assessment, and application of innovative solutions

• 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

• Prepares clear and concise technical reports, participates, or leads project teams

• Executes on strategy, vision, and direction set by line management

• Takes a lead in decision-making processes within the project team by actively engaging in scientific and technical discussions

• 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

• Ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

• Performs other tasks and assignments as needed and specified by management

• BA/BS in Chemical Engineering, Biochemical Engineering, Biochemistry, or other relevant discipline and 5-12+ years of Biotechnology industry experience in downstream AAV purification technologies and theory. Proven experience in the scale-up and technology transfer from pilot plant to manufacturing with extensive chromatography experience. Downstream experience with writing regulatory documents to support filings (INDs/CTAs, Briefing Materials, and BLAs/MAAs). 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 downstream process development and GMP manufacturing OR

• Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, or other relevant discipline

  and 6-10+ years of similar experience noted above OR

• PharmD or PhD in Chemical Engineering, Biochemical Engineering, Biochemistry, or other relevant discipline and 4+ years of similar experience noted above

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members

• Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines

• Demonstrated ability to complete technical assignments by supporting the design, execution, and interpretation of complex experiments

• Ability to deliver results within defined budget, timing, and resources constraints. Awareness of impact(s) on other functional areas

• Self-motivated and comfortable working as part of a cross-functional teams, and an ability to meet timelines efficiently and productively

• Ability to monitor on-going experiments and suggest alternatives or solutions

• Commitment to continuous process improvement, driving efficiencies in all areas of operation

• Advanced knowledge with Excel, Word, PowerPoint, and other associated software used in the scientific field

• Excellent verbal and written communication skills

• Advanced planning, organization and time management skills including the ability to support and prioritize multiple projects

• Expert level knowledge of HEK-based AAV based gene therapy downstream process with a good understanding of manufacturing and testing/characterization methods required

• Expert level knowledge of the biologics drug development process is preferred

• Knowledge of GLP and GMP environments as they pertain to gene therapy process development and Quality Control (QC) testing

• Knowledge of CHO-based antibody expression system optimization is a plus

• Familiar knowledge of CMC and regulatory requirements, including the development of process and product specifications and writing and reviewing development reports

• Skilled at AAV purification downstream development, such as UF/DF, affinity chromatography, anion exchange chromatography from small scale to pilot scale

• Knowledge of cell-based methods associated with bioanalytical analytical method development (e.g., TCID50, Potency assay, viral transduction, and ELISA methods)

• Expertise in laboratory operations, including budgeting, capital expense procurement and IQ/OQ, safety, and status reporting to Senior Management

• Ability to lead analytical method and downstream process development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs) is desired

• Knowledge and experience with novel methods in AAV characterization (e.g., ddPCR, DLS, AUC, NGS, etc.) is preferred

• Proven expertise with chromatography bioprocessing equipment and its application to gene therapy process development and GMP manufacturing required

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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