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:
The Associate Scientist USB is a contributor in many activities required to develop, scale-up/down, characterize, and potentially transfer the upstream engineering of antibody and gene therapy production, process development, and associated analytical tools to support research, development, and pre-clinical candidates. This role involves the operational build-out and execution of development studies necessary to produce and characterize mammalian cell-based material from early discovery to later-stage development. In addition, this role will involve successful delivery of upstream material and optimization studies from flask to SUB-scale processes. This scientist will work with a group of product and analytical development engineers and scientists to support a multi-platform biologics group and will strive to become one of the subject matter experts (SME) for both internal and external (CRO) & (CDMO) projects in areas of downstream process development. This person will need to be aware of, and strive for adherence to, relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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Your Contributions (include, but are not limited to):

• This person works with scientists and engineers to support the execution of the activities associated with the development of processes relevant to biological therapeutic products including cell line screening, media screening, transfection optimization, ultrafiltration/depth filtration, and other upstream processes as well as assists in the in-process analytical assessments in a Research and Development environment
• This person is a driver for the development of downstream and purification processes for the generation of material as well as early optimization studies, working in conjunction with additional upstream and downstream engineers as well as an analytical team for the characterization and release testing to support research, pre-clinical, and IND-enabling studies
• This person will help to understand process and production development activities to support development candidates and activities for timely IND, BLA and all relevant ex-US regulatory filings
• This person works 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 and assures the development of, effective execution, science-driven, phase appropriate, and risk-based process development strategies to support development projects from candidate nomination to clinical development and commercial manufacture
• Helps to identify and resolve technical problems through scientific understanding, options assessment, and application of innovative solutions
• Works with internal staff and collaboration partners to generate project and cost proposals, timelines, and work plans by applying scientific knowledge and business expertise
• Helps prepare clear and concise technical reports
• Helps develop strategy, vision, and direction set by line management
• Contributes to the decision-making processes within the project team by actively engaging in scientific and technical discussions
• Responsibility to participate 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 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 0-2+ 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 OR
• Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and some similar experience noted above
• Proficient level understanding of HEK-based AAV based gene therapy products with a good understanding of manufacturing and testing/characterization methods required
• Proficient level knowledge of the biologics drug development process is recommended
• Basic knowledge of GLP and GMP environments as they pertain to gene therapy process development and Quality Control (QC) testing is a plus
• Familiar knowledge of CMC and regulatory requirements, including the development of process and product specifications and writing and reviewing development reports is a plus
• Proficient level transfection and stable expression principles associated upstream development of mAbs and AAV is highly desirable
• The understanding of characterization methods associated with protein and nucleic acids for the purposes of downstream process development is a plus
• Knowledge of laboratory operations, including budgeting, capital expense procurement and IQ/OQ, safety, and status reporting to Senior Management
• 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 team, 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.
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The hourly rate we reasonably expect to pay is $33.98-$48.01. 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 15% 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

Please refer the Job description for details