Senior Scientist, Analytical Development

Who We Are Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life‑changing treatments for patients with under‑addressed neurological, psychiatric, endocrine and immunological disorders. Our portfolio includes FDA‑approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader‑Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline of clinical candidates. About the Role This position will serve as analytical SME to support Antibody Biologics CMC development, developing, establishing, qualifying, and transferring analytical methods used to monitor the critical product quality of Antibody Biologics drug substance and drug product. The candidate will contribute to the development and implementation of analytical development strategies and workflows, ensure all work is in compliance with cGMP, safety, and regulatory requirements, and participate in analysis and evaluation of process intermediates, drug substance, and drug product at all stages of development. Your Contributions & Responsibilities Lead analytical method development, qualification/validation and transfer for the characterization of Antibody Biologics utilizing various analytical separation techniques including SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D‑LC, CE‑SDS, iCIEF. Expand internal analytical capabilities to support method development, qualification, validation, transfer activities, and process development activities such as cell line development, upstream/downstream development and formulation development. Support off‑site analytical method transfers, manufacturing support, and interaction with external vendors when needed. Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC analytical development strategies. Lead laboratory personnel and ensure laboratory safety practices. Perform additional duties as assigned. Requirements BS/BA in chemistry or a closely related field with 5+ years (7+ years preferred) of pharmaceutical industry experience focusing on separation method development OR MS/MA in chemistry or related field with 3+ years (5+ years preferred) of pharmaceutical industry experience OR PhD in chemistry or related field with 2+ years (5+ years preferred) of pharmaceutical industry experience. Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development. Proficient in characterization of antibody modalities using various analytical technologies with a focus on separation technologies, including liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, and mass spectrometry. Hands‑on experience in homodimer/heterodimer separation method development for bispecific/tri‑specific antibodies is preferred. Method development, qualification, validation, and transfer experience in analytical development. Comprehensive understanding of cGMP requirements in drug substance and drug product. Expert knowledge of cross‑functional understanding related to drug development. Knowledge of FDA, EMA, WHO, and ICH regulatory requirements. Excellent laboratory and productivity skills. Excellent interpersonal skills with strong oral and written communication abilities. Excellent problem‑solving and critical‑thinking skills. EEO Statement Neurocrine 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 exactly with what we have outlined. Compensation & Benefits 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 the 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 include a retirement savings plan with company match, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits covering medical, prescription drug, dental and vision in accordance with the terms and conditions of the applicable plans. #J-18808-Ljbffr Neurocrine Biosciences