Senior Scientist, CMC Downstream Process 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. 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:We are seeking a highly motivated and detail-oriented Senior Scientist/Engineer to join our Biologics Process Development team and advance Neurocrine’s antibody and bioconjugate assets from early preclinical development through commercialization. This role will lead downstream process development activities at bench and pilot scales, while supporting scale-up, technology transfer and implementation at external manufacturing facilities. The successful candidate will bring deep technical knowledge and hands-on experience in purification technologies, biologics process development, bioconjugation process development, and manufacturing. Working in a collaborative, cross-functional environment, you will strengthen technical capabilities and contribute to the development of best-in-class biotherapeutics.

_

Your Contributions (include, but are not limited to):

• Independently design and execute scalable purification process for Neurocrine biologics assets across diverse modalities including monoclonal antibody, bispecific, APC (antibody-peptide conjugate), AOC (antibody-oligonucleotide conjugate), and others

• Serve as a downstream process development subject matter expert, leading the selection, optimization and troubleshooting of chromatography resins and modalities (e.g., affinity, AEX, CEX, HIC, MMC), as well as filtration processes

• Support process scale-up, technology transfer initiatives, contract manufacturing activities and external interactions as assigned

• Contribute to the continued evolution and improvement of internal platform purification processes

• Drive documentation excellence by authoring and reviewing protocols, technical reports and raw data to ensure data quality and compliance

• Provide scientific analysis to support process development and program decisions

• Evaluate and implement improvements to enhance product quality and manufacturing consistency

• Identify process challenges and perform troubleshooting activities within assigned scope

• Promote and ensure a safe and compliant laboratory work environment

• Mentor junior scientists and support team development

• Perform other duties as assigned

Requirements:

• BS/BA degree in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and 4+ years of relevant experience OR

• MS/MA degree in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and 2+ industry experience preferred OR

• PhD in chemistry, biochemistry, biophysics, biology, or similar scientific discipline and 0 years of relevant experience

• Hands-on experience with downstream processing unit operations, including chromatography (e.g., affinity, IEX, HIC), membrane-based separation (e.g., depth filtration, UF/DF) and column-packing is required

• Demonstrated ability to operate and troubleshoot laboratory and pilot-scale chromatography skids and other bioprocessing equipment (e.g., AKTA and Repligen systems)

• Strong working knowledge of chromatography and filtration technologies

• Strong working knowledge of process development and scale-up strategies

• Strong laboratory and productivity skills

• Experience with APC, AOC, siRNA and AAV is preferred

• Manufacturing experience internally or with external partners is preferred

• Experience with high-throughout platform is preferred (e.g., Tecan)

• Experience and knowledge of protein characterization and analytical techniques is preferred (e.g., SEC, SDS-PAGE, CE, ciEF)

• Knowledge of DOE and statistical data analysis is preferred

• Familiarity with cGMP requirements is preferred

• Strong knowledge of scientific or engineering principles and methods

• Demonstrated ability to interpret complex data sets and articulate scientific rationale

• Consistently recognizes anomalous results and determines appropriate next steps

• Explains data implications clearly to cross-functional stakeholders

• Builds effective internal and external working relationships

• Detail oriented with strong analytical thinking

• Works effectively as part of a team and may lead defined activities

• Strong communication skills

• Understands broader scientific impact on project outcomes

• Manages multiple deadlines with accuracy and efficiency

• Demonstrates developing project leadership skills

#LI-LS1

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.

_

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.