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. The company's diverse 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 including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than 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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
About the Role:
This position will serve as analytical SME to support Antibody Biologics CMC development. Develop, establish, qualify, and transfer analytical methods used to monitor the critical product quality of Antibody Biologics drug substance and drug product. Contribute to the development and implementation of analytical development strategies and workflows. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of process intermediate, drug substance, drug product at all stages of development process.
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Your Contributions (include, but are not limited to):
- Lead analytical method development, qualification/validation and transfer for the characterization of Antibody Biologics utilizing various analytical separation techniques including but not limited to 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 as well as process development activities such as cell line development, upstream/downstream development, 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
- Lab Personnel and ensure laboratory safety practices
- Other duties as assigned
Requirements:
- BS/BA degree in chemistry or closely related field and 5+ years (7+ years preferred) of pharmaceutical industry experience, focusing on separation method development OR
- MS/MA degree in chemistry or closely related field preferred and 3+ years (5+ years preferred) of pharmaceutical industry experience noted above OR
- PhD in chemistry or closely related field (2+ 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 but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry. Hands on experience in homodimer/heterodimer separation method development for bi-specific/tri-specific antibodies are 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
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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 to exactly what we have outlined in the job description.
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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.
