Sr. Scientist, CMC Antibody Development, Biologics (#SJ-0802)

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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons 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 LinkedIn X and Facebook. (*in collaboration with AbbVie)

• Responsible for pre-clinical and clinical phase scientific process research and development for gene therapy and antibody modalities including internal development and manufacture of GLP (Good Laboratory Practice) as well as support for external manufacture of GMP (Good Manufacturing Practice) drug substance

• Make significant upstream and/or downstream laboratory contributions in order to enable drug-substance process optimization to ensure robust delivery of the Neurocrine pipeline

• Provide project leadership or support for CMC (Chemistry Manufacturing and Controls) programs and lead work streams and platform projects within the Chemical Development team

• Support project planning efforts and participate in cross-functional teams representing Chemical Development

• Maintain accountability for assigned deliverables for R&D and manufacturing plans for Chemical Development projects

• Ensure laboratory work is done productively with adherence to laboratory practices

• Perform process R&D and optimize drug substance processes

• Recommend alternatives and perform research toward new methods and techniques to solve problems

• Assist with managing development manufacturing activities and may interact with contractors

• Provide input for portions of CMC regulatory documentation and supporting work

Requirements:

• Masters degree or equivalent in Chemistry Chemical Engineering or a related field

• 3 years of experience in the field of biologics process development or biologics manufacturing

• Employer will accept a Bachelors degree or equivalent in Chemistry Chemical Engineering or a related field and 4 years of experience in the field of biologics process development or biologics manufacturing in lieu of a Masters degree or equivalent and 3 years of experience

• Work experience to include: (1) 3 years of experience (or 4 years of experience with a Bachelors degree) with scientific principles methods and techniques. (2) 3 years of experience (or 4 years of experience with a Bachelors degree) working with laboratory equipment and tools including incubators biosafety cabinets rocking bioreactors and stirred tank bioreactors of scales from 250mL to 50L. (3) 3 years of experience (or 4 years of experience with a Bachelors degree) with aseptic technique. (4) 3 years of experience (or 4 years of experience with a Bachelors degree) with gene therapy or antibody development and manufacture. (5) Recognizing anomalous and inconsistent results and interpreting experimental outcomes. (6) Explaining the process behind the data and implications of the results and planning next steps. (7) Biologics (upstream) as well as current techniques and literature. (8) Drug substance manufacturing both internal and with external partners. (9) Good understanding of cGMP requirements and regulatory aspects of biologics. (10) Demonstration of cross-functional understanding related to drug development

• Any and all experience may be gained concurrently

• The position requires 5% domestic travel and 15% international travel; travel expenses paid by employer

• 40 hrs./wk.

• Salary: $110800.00 to $177400.00/yr.

• Address of employment: Neurocrine Biosciences Inc. located at 6027 Edgewood Bend Court San Diego CA 92130

• #LI-DNI

How to Apply:

Individuals interested in applying for this position must email resumes to Neurocrine Biosciences Inc. at referencing Job #SJ-0802 or mail resumes to Neurocrine Biosciences Inc. Attn: Elina Yapparova Job #SJ-Edgewood Bend Court San Diego CA 92130.

Neurocrine Biosciences Inc. is an EEO/AA/Disability/Vets employer.