Who We Are:
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.
What We Do:
Neurocrine Biosciences is a 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, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie
About the Role:
Leads within a group, the activities required to develop, scale-up/down, characterize, and potentially transfer the upstream expression of antibody and AAV-based gene therapy production, process development, and associated analytical tools to support research, development, and pre-clinical candidates. This involves the operational build-out and production to support key development studies necessary to characterize AAV material from early discovery to IND-stage development. In addition, this role involves the successful delivery of scale-up studies from flask to pilot-scale processes. This leader serves as a mentor for a growing group of scientists and engineers and may participate as the subject matter expert (SME) for both internal and external (CRO) & (CDMO) projects in all areas of biological upstream process development for Neurocrine’s biotherapeutic pipeline. This person will strive for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Your Contributions (include, but are not limited to):
- 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
- 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
- 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 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, 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
- 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
Requirements:
- 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
- Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and 6+ 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
- Expert level knowledge of HEK-based AAV based gene therapy products with a good understanding of manufacturing and testing/characterization methods required
- Expert level knowledge of the biologics drug development process is recommended
- 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
- Expert level knowledge of mammalian cell culture and associated upstream development
- 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 upstream 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 single-use bioprocessing equipment and its application to gene therapy process development and GMP manufacturing preferred
- 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
- 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
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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.
The annual base salary we reasonably expect to pay is $122,000.00-$195,200.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.