Sr. Engineer or Sr. Scientist, API Development

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.What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. 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, classic congenital adrenal hyperplasia, 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, visit , and follow the company on , and . (*in collaboration with AbbVie)About the Role: Responsible for cell culture process development activities associated with the advancement of biologic assets from pre-clinical through commercial phases. This includes laboratory experimentation and collaboration with external partners for process development and clinical or commercial manufacturing. Strong scientific knowledge is required to enable cell culture process parameter establishment, optimization, and characterization to ensure robust delivery of the pipeline. The position also requires regulatory awareness, quality and cGMP knowledge, and an ability to build relationships with cross-functional and external partners. May train other scientists, engineers and/or team members.Your Contributions (include, but are not limited to):Apply scientific or engineering principles with increasing complexity to lifecycle responsibilities from cell line development to cell culture process development including process definition, optimization, characterization, and validationMay lead cell culture process scale-up and technology transfer initiatives identifying and mitigating risksSupports project planning and advancement efforts. Participates in cross-functional teamsMaintains accountability for assigned deliverables including production plans for development projectsMay contribute to risk assessments to support project advancementIndependently designs, plans, and executes cell culture activities towards the goals of one or more development projects to support preclinical through commercial activitiesEnsures laboratory work is efficient, productive, and adheres to safe practicesIndependently identifies process challenges and leads necessary optimization activities including trouble-shooting experimentationIdentifies, recommends, and evaluates new methods and techniques to improve product quality, manufacture consistency, or to achieve cost effectivenessAssists with managing contract manufacturing activities and may directly interact with contractorsMay provide input for select sections of CMC regulatory documentation and supporting workMay train lower-level scientists and/or team membersBuild internal and external professional relationshipsOther duties as assigned Requirements: BS/BA degree in chemical engineering, biochemical engineering, or similar engineering discipline AND 4+ years of relevant experience ORMS/MA degree in chemical engineering, biochemical engineering, or similar engineering discipline AND 3+ years of relevant experience ORPhD in chemical engineering, biochemical engineering, or similar engineering discipline AND 2+ years relevant experience; may include postdoc experienceExperience with cell culture techniques in a process development environment including hands-on experience with various bioreactor models and bioreactor scales. Must be skilled in aseptic techniqueStrong knowledge in process optimization approaches and understanding of potential process risksExperience with high throughput cell culture development and familiarity with current technologies for improvement of cell productivity and product qualityKnowledge of or experience with cell line developmentManufacturing experience including with external partnersGood understanding of cGMP and regulatory requirementsDemonstration of cross-functional understanding related to drug developmentStrong knowledge of scientific or engineering principles, methods and techniquesConsistently recognizes anomalous and inconsistent results and interprets experimental outcomesAble to explain the process behind the data, implications of the results, and plan next stepsAbility to build and manage internal and external working relationshipsDetail orientedAbility to work as part of a team. May train lower-level scientist or engineersStrong communication, problem-solving, analytical thinking skillsBroader picture understanding of scientific impact on teamAbility to meet multiple deadlines, with a high degree of accuracy and efficiencyGood project management and interpersonal skills#LI-DM1Neurocrine Biosciences is an EEO/Disability/Vets employer.We are committed to building a workplace of belonging, respect, and empowerment, 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 $110,800.00-$151,000.00. 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 20% 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.

Neurocrine Biosciences