Sr. Scientist, CMC Antibody Development, Biologics

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 process development for therapeutic antibodies including all aspects of DS upstream manufacturing

• Collaborates with discovery research and product development to build the scientific knowledge, capabilities, and strategies in biotherapeutic product development that enable fast to clinic/fast to market product development and commercialization

• Drives the development of upstream platform processes for the generation of material as well as the early-stage optimization studies, working with a downstream and analytical team 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

• 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 precise 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

• BS/BA in Chemical Engineering, Biochemistry, Biology or other relevant discipline and 6+ years of biotech/pharmaceutical industry experience in mammalian cell culture process development OR

• MS/MA in Chemical Engineering, Biochemistry, Biology or other relevant discipline and 4+ years of similar experience noted above OR

• PhD in Chemical Engineering, Biochemistry, Biology or other relevant discipline and 2+ years of similar experience noted above; may include postdoc experience OR

• Skilled in the upstream process development, optimization, implementation, and manufacturing of therapeutical antibodies

• 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; must be self-motivated, detail-oriented, decisive

• 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

• Ability to work as part of a cross-functional teams and meet timelines efficiently and productively

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

• Advanced knowledge with Excel, Word, PowerPoint, JMP 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 CHO-based antibody expression system and biologics cell culture process development

• Proven expertise with cell culture bioprocessing equipment including ambr250, bench top and pilot scale single-Use Bioreactors and their control system, e.g., Sartorius and ThermoFisher Scientific bioreactor control system programing and PID tuning

• Proficiency in DOE, statistical analysis and data interpretation

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

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

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

• Ability to guide and monitor upstream process development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs) is desired

• Proven record of aseptic technique

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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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